The Mazada Pharma Guide - 1st to 15th May 2015

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ACTIVE PHARMA INGREDIENTS INTERMEDIATES jAlendronate Sodium / Acid j2,3,4-Trimethoxy Benzaldehyde jAllopurinol jBisacodyl BP/ USP j2-Chloro1,3-BIS(Dimethylamino)Trimethinium Hexa Fluoro jEosin Di Sodium FRP jEplerenone Phosphate (Etoricoxib Intermediate) jFluorescein Sodium USP/ Acid j3,4,5 Trimethoxy Benzoic Acid Chloride jFosphenytoin Sodium USP j3-(chloromethyl)-5,5-diphenylimidazolidine-2,4-dione jIbandronate Sodium / Acid j3-(N-Methyl-N-Pentylamino)Propionic Acid Hydrochloride (Ibandronate Intermediate) jOndansetron HCL j4 Aminobutyric Acid jPamidronate Di Sodium / Acid j5-[4-[2-(5-Ethyl-2-Pyridyl)Ethoxy]phenyl]methylene-2-4thiazolidinedione jPhenobarbital (Pioglitazone Intermediate) jPhenytoin Base/Sodium BP / EP j5 Chloro 4 Amino-2,1,3,benzothiadiazole (Tizanidine Intermediate) jPicosulfate Sodium BP / USP jBenzilic Acid jPioglitazone HCL IP / BP jCaproic Anhydride / Hexanoic Anhydride jPropyl Gallate BP / EP jDibenzylphosphono)-3-oxymethyl] Phenytoin or 5,5-Diphenyl-3[(phoshoonoxy) jRisedronate Sodium / Acid methyl]-2,4-imidazolinedione dibenzyl ester jRisperidone jSilver Sulphadiazine USP jDi Benzyl phosphate / Silver Salt / Potassium / Sodium jTelmisartan jTizanidine HCL USP jEthylene Urea/ Acetyl Ethylene Urea jTrimetazidine HCL JP/BP/EP jGallic Acid jHeptanoic Anhydride UNDER DEVELOPMENT jN-Methyl-N-Pentylamine jAdrenaline jTiotropium Bromide jN-Pentyl Bromide (N Amyl Bromide) jCiticoline jBuslfan jPotassium Hydroxide (Powder) jFlupirtine Maleate jClopidogrel jSilver Nitrate jGranisetron jHydrochlorothiazide jMesna jTetra benzyl pyrophosphate jNizatidine jRaloxifene JPN PHARMA PVT. LTD. ( (WWHHOO GGMMPP CCeerrttiiffiieedd)) Off:101, Arihant Enclave (Falguni CHS),Opp. Rosy Blue Diamond Company, Ashok Nagar, Ashok Chakravarty Road, Kandivali (East), Mumbai - 400 101. India. Ph: ++ 91-22-28466000 / 07 / 08 / 09 Email:[email protected] Internet:www.jpnpharma.net Plant : T-108/109/11, MIDC, Tarapur, Boisar, Dist. Thane, Maharashtra, India 53

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VSalt licks mainly contain salt and some trace minerals like iron, iodine, copper, manganese, cobalt etc. VAvailable pack size: 1kg, 2kg, 5kg, 10kg, 20kg. VWe can manufacture these licks under your brand name for distribution as well as for export purpose RAJAN HEALTH CARE 56/17 D-II Block, M.I.D.C., Chinchwad, Pune - 19. Tel.: 020-27441990 * Mob.: 9823506697 / 9765560117 Email : [email protected] 71

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CONTENTS PHARMA EDITORIAL Botanical drug for dengue 76 NEWS 78 PUBLISHER ARTICLE Prakash Anjalekar Phase-3 trials of tildrakizumab in patients with moderate-to-severe plaque 80 psoriasis meet primary endpoints SALES MANAGER Sarfaraz A. Chaudhary FOOD ARTICLE Mob.: 7045337706 USDA offers $6 million for antimicrobial resistance research 82 BUSINESS EXECUTIVES MACH. ARTICLE Telma D’souza Opportunities in life-cycle microbiology testing services 86 Priyanka Gawli SPECIAL FEATURE ARTICLE GRAPHIC DESIGNER Pravin Ubhare API Sourcing for Regulated Markets - Beginner's Guide 98 Shivraj Kudtarkar Thirteen Five U-shaped titanium dioxide market will start to turn out the reasonable 99 PRICES CIRCULATION DEPT. Global Chemical Import Prices 88 jayesh Nikam Indian Chemical Export Prices 89 HEAD OFFICE : Gala No. Import Statistics 90 1A, Sharma Compound, Export Statistics 91 Old Nagardas Road, Andheri (E), Mumbai Chemical Prices 93 Mumbai- 400 069. Mumbai Drugs Prices 94 Tel : 022-6555 1141/42/38 Chennai Chemical Prices 95 Email : [email protected] Web : issuu.com/themazdapharmaguide Hyderabad Drugs Prices 96 DPCO 101 BARODA/AHMEDABAD Mr. Sunil (Mob. : 09427521796) MEETINGS & CONFERENCES 97 Edited, Published and Printed PRODUCT WISE INDEX 103 By Prakash Anjalekar, Gala N. 1A, Sharma Compound, ADVERTISER’S INDEX 137 Old Nagardas Road, Andheri (E), Mumbai - 400 069. Maharashtra On Behalf of SUBSCRIPTION FORM 84 Owners Mazda Publications THE MAZADA PHARMA GUIDE  1May - 15 May 2016 75

PHARMA EDITORIAL Botanical drug for dengue engue, a mosquito-borne viral cle pain, swollen lymph nodes, studies meeting all regulatory disease, poses a significant headache, fever, exhaustion, and standards of India and other Dglobal public health risk. India rash. The presence of fever, rash, regulatory agencies worldwide. is the in grip of its worst dengue and headache is characteristic of In tropical countries such as fever outbreak in years, with more dengue fever.Dengue is prevalent India where periodic dengue out- than 6,500 confirmed cases and at throughout the tropics and subtrop- breaks can be correlated to the least 25 deaths in the capital New ics.Dengue fever is caused by a high prevalence of the mosquito Delhi so far this season. Dengue virus, and there is no specific medi- vector, circulation of all four dengue generally causes a debilitating cine or antibiotic to treat it. For typi- viruses (DENVs) and the high pop- fever, headaches, rash and joint cal dengue fever, the treatment is ulation density, a drug for dengue is and muscle pain.People who are directed toward relief of the symp- being increasingly recognized as infected will not have any symp- toms (symptomatic treatment).The an unmet public health need. toms, but others can develop a acute phase of the illness with A botanical drug is a plant- potentially fatal complication known fever and muscle pain lasts about derived medicinal product that is as dengue haemorrhagic fever. one to two eeks.Dengue hemor- intended for use in the diagnosis, The dengue virus is transmitted to rhagic fever (DHF) is a specific cure, mitigation, treatment or pre- people primarily via two species of syndrome that tends to affect chil- vention of disease in humans. mosquitoes: Aedesaegypti and dren under 10 years of age. This These medicines are based on Aedesalbopictus. There are four complication of dengue causes complex botanical compounds and strains of virus.After being infected abdominal pain, hemorrhage can offer multiple agent solution, with one type of dengue you are (bleeding), and circulatory collapse selectively and differentially affect- immune to that specific type for life, (shock).The prevention of dengue ing various target tissues. These but not the other strains.The risk of fever requires control or eradication characteristics make botanical haemorrhagic fever increases if you of the mosquitoes carrying the virus drugs safe and effective. catch dengue more than once.The that causes dengue.A vaccine for India represents nearly 50 per virus is estimated to infect up to dengue fever was approved in April cent of the global population esti- 400 million people globally each 2016 for use in dengue-endemic mated to be at risk of dengue. year. There is also a growing num- areas. Severe dengue, which is potentially ber of fatalities and allegations Now, the International Centre for fatal, correlates with very high virus authorities have been slow to Genetic Engineering and load, reduction in platelet counts respond with tragic conse- Biotechnology (ICGEB), an interna- and haemorrhage. Antiviral therapy quences.At some hospitals, some tional, non-profit research organisa- to reduce high virus load may be patients share beds. tion, and Sun Pharma, India's top beneficial in attenuating disease The high and growing burden of pharmaceutical company, have severity. Through this collaboration dengue in India suggests a press- signed an agreement to develop a companies are developing innova- ing need to improve its novel botanical drug for treatment tive botanical opportunities to public health efforts. It is estimated of dengue. Through this agree- identify herbal options that could be the cost of medical care for those ment, Sun Pharma commits devel- source of dengue inhibitory activity. who get infected with dengue is opment of Cissampelospariera The developmental efforts of this equal to nearly $550 million annual- (Cipa), a botanical drug in collabo- collaboration will aim to explore ly. Additional indirect economic ration with ICGEB.Through this how the extract prepared from Cipa costs, which are borne by patients agreement Sun Pharma will follow Linn can inhibit the replication of and their families, lost wages, will up on earlier pre-clinical collabora- virus in living cells against dengue be another US$ 550 million. It is tion between ICGEB and erstwhile infection.Using the knowledge of thus believed that dengue costs Ranbaxy Laboratories Ltd. Sun traditional Indian medicine, India India over $1.1 billion annually. Pharma will develop Cipa, a botani- should explore the indigenous Dengue fever is a disease cal drug following a drug registra- herbal bio-resource to identify caused by a family of viruses that tion process similar to a new chem- plants with pan-DENV inhibitory are transmitted by ical entity, consisting of all required activity and identified CIPA as mosquitoes.Symptoms of dengue in-vitro, in-vivo, pre-clinical and a safe, affordable and effective fever include severe joint and mus- clinical solution. 76 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

THE MAZADA PHARMA GUIDE  1May - 15 May 2016 77

PHARMA NEWS Pfizer to pay $150 Janssen inks the lives of men with this disease.' million to Allergan for collaboration & PARP proteins play a key survival terminating proposed license pact with role in DNA repair in cancer cells. merger deal Tesaro for niraparib By inhibiting PARP, certain defective cancer cells are not able to repair New York : Pfizer Inc announced in prostate cancer themselves, leading to cell death. A that the merger agreement between Raritan, New Jersey : Janssen portion of men with prostate cancer the company and Allergan plc has Biotech, Inc., one of the Janssen have these defective cancer cells been terminated by mutual agree- Pharmaceutical Companies of and may benefit from use of a ment of the companies. The deci- Johnson & Johnson, has entered a PARP inhibitor, either alone, or in sion was driven by the actions worldwide collaboration and license combination with other treatments. announced by the US Department agreement with Tesaro, Inc., for eKincare comes out of Treasury on April 4, 2016, which exclusive rights to the investigation- with a study the companies concluded qualified al compound niraparib in prostate on lifestyle as an “Adverse Tax Law Change” cancer. Niraparib is an orally admin- under the merger agreement.In istered poly polymerase (PARP) disease in India connection with the termination of inhibitor, currently in late-stage the merger agreement, Pfizer has development for patients with Mumbai : eKincare, India’s fastest agreed to pay Allergan $150 million metastatic breast cancer and ovari- growing healthcare technology has for reimbursement of expenses an cancer.Acording to terms of the come out with a study on aware- associated with the license agreement and collaboration ness around the lifestyle disease transaction.“Pfizer approached this arrangement, Janssen will have among people in India. The study transaction from a position of global rights and be responsible for was conducted across eKincare’s strength and viewed the potential all development and user base in India.The study combination as an accelerator of commercialization activities for nira- revealed that the single most impor- existing strategies,” stated Ian parib for use in prostate cancer, tant step to prevent diabetes is to Read, chairman and chief executive except in Japan. Tesaro will main- monitor your blood sugar levels reg- ularly. However, despite the wide- officer, Pfizer. “We remain focused tain global development, manufac- on continuing to enhance the value turing and commercial rights for all spread education and awareness campaigns, almost 80 per cent of of our innovative and established other indications. the users on the platform are either businesses. Our most recent prod- In addition to an upfront payment, not aware or have not taken a blood uct launches, including Prevnar 13 Tesaro will be eligible to receive sugar test in the past one year. This in adults, Ibrance, Eliquis and milestone payments, based upon is a startling revelation given that Xeljanz, have been well-received in the achievement of specified devel- most of them belong to educated, the market, and we believe our late opment, regulatory and commercial urban population. stage pipeline has several attractive milestones, as well as royalties on The data also indicated that the commercial opportunities with high future worldwide sales. Separate to risk of diabetes almost doubles for potential across several therapeutic the exclusive license and collabora- the age group of 41-50 when com- areas. We also maintain the finan- tion arrangement, Johnson & pared to the age group of 31-40 cial strength and flexibility to pursue Johnson Innovation – JJDC, Inc. will indicating 41-50 years to be the attractive business development make an equity investment in most risk prone years. This increase and other shareholder friendly capi- Tesaro. in risk is for both men & women. tal allocation opportunities.” 'PARP inhibitors are an exciting, While rudimentary lifestyle and “We plan to make a decision emerging class of medicines in unhealthy food are the biggest con- about whether to pursue a potential prostate cancer, and we believe tributors, it is critical that a mass separation of our innovative and niraparib will perfectly complement awareness campaign or programme established businesses by no later our existing portfolio,' said Peter F. is launched to educate people on than the end of 2016, consistent Lebowitz, M.D., Ph.D., oncology not just healthy lifestyles but also on with our original timeframe for the therapeutic area head, Janssen importance of preventive healthcare decision prior to the announcement Research & Development, LLC. mechanisms such as tracking & of the potential Allergan transac- 'Our team is eager to apply its monitoring their vitals like BP, BMI, tion,” continued Read. “As always, prostate cancer expertise to nira- blood sugar values. This is essential we remain committed to enhancing parib, and enthusiastic about its because the cost/burden of living shareholder value.” potential to expand our impact on with diabetes is far greater than prevention. Regular monitoring helps 78 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

PHARMA NEWS one to spot the risks early and take betes and hypertension prevention methodology creates a technology preventive measures and management program supported independent environment that is con- The data also suggested that the by Eli Lilly and Company under the ducive to staying engaged throughout risk of diabetes increases consider- Lilly NCD Partnership.According to for advanced learning. Adaptable to ably (almost by 70 per cent) as one the International Diabetes Federation, audience requirements, it has been moves from being normal weight to India has the second largest popula- successful in enhancing the capacity obese, indicating that obesity is one tion living with diabetes in the world, of health workers for community inter- of the key factors of diabetes. These second only to China. Higher action and counseling, and in motivat- insights are extremely significant incomes, more sedentary lifestyles ing them to promote opportunistic since they are based on crowd and diets heavy in starches and sug- screenings in different socio-cultural sourced data of eKincare, hence pro- ars as well as high blood pressure are contexts. vides a realistic understanding of the all factors contributing to the spread This package has been comple- level of awareness and the need for of the disorder. While today there are mented with advocacy efforts to more impactful education. “Our pri- about 65 million people with diabetes secure increased attention and mary endeavour at eKincare is to help in India, the number is expected to involvement of the government for individuals assess, track and stay increase to 109 million by 2030. scaling up and mainstreaming NCD informed about their health. Launched in 2012, Project UDAY is related activities. For the first time in Awareness, education and regular led by the Public Health Foundation of India, our unique, evidence-based monitoring of your vitals is a key step India (PHFI), New Delhi in partnership approach will be applied to create towards preventing and controlling with Population Services International effective patient networks in the field chronic conditions like diabetes, (PSI) and Project HOPE. UDAY com- of noncommunicable disease. This hypertension and CVD,” said prises a priority set of five synergistic will enable the community to identify KiranKalakuntla, Founder, eKincare. ecosystem interventions with the successful behaviors and strategies, India has the second largest num- overarching goal to prevent, detect, and develop action plans to adopt ber of people suffering from diabetes and reduce the risk of diabetes and them.India's greatest national treasure and may soon earn the ignominy of hypertension and to improve the man- is our people. We cannot afford to being the world’s capital. Talking agement of individuals with either of neglect their wellbeing and allow so about diabetes, very recently Prime these conditions in two study sites. many of our citizens to face the con- Minister NarendraModi in his monthly These sites are two geographically sequences of NCDs. Project HOPE broadcast asked citizens to defeat it and culturally distinct areas (South approach in UDAY is mobilizing by modifying their lifestyles. and North India) located in patients through patient networks and eKincare is India’s fastest growing Vishakhapatnam (Vizag) in the state at the same time strengthening the healthcare technology company that of Andhra Pradesh and Sonipat in service delivery via health care work- aims to be one stop destination for all Haryana. ers, said CheenaMalhotra, Program your healthcare needs. Be it digitiza- Project HOPE main focus is to Manager for Project HOPE India. tion of your medical history and early address the magnitude of diabetes Project HOPE has been very pleased detection of health risks based on and hypertension by developing with the success of the program strong technology driven data analyt- skilled health care professionals and where participating health workers ics to providing a personalized health noncommunicable diseases (NCD) showed 95 per cent of improvement plan, Hyderabad-based eKincare, patient networks for community in knowledge on the posttest verses helps you lead a smarter way to your empowerment. As the capacity build- 15 per cent at the beginning of the healthier future. eKincare has tied up ing partner, Project HOPE is focused training. with some of the largest service on advancing knowledge for transfor- Through UDAY, we are bringing providers in the country and has a mative action towards early detection, meaningful, long-term changes that presence across 2000 locations in the prevention, management and timely benefit people with diabetes today country, thereby having one of the referrals of NCDs. This involves and will hopefully prevent its onset largest body, dental and vision net- understanding and responding to the with others moving forward, said works in India. specific needs of the community Craig Waugh, Global Leader, Lilly Project HOPE, Eli towards NCD care and manage- NCD Partnership. Our ultimate goal is ment.To maximize learning, Project to use the research coming out of Lilly make strides HOPE has crafted its training method- projects like UDAY to advocate for against diabetes and ology on the VIPP (Visualization in wider scale up in order to positively hypertension in Participatory Programs) approach impact more people in India. which involves adult participatory Founded in 1958, Project HOPE India learning. Extensively participatory, it (Health Opportunities for People Mumbai : Project HOPE, the global pivots around case scenario build- Everywhere) is dedicated to providing health organization, is experiencing ups, informative live sessions, demon- lasting solution to health problems great success in India in its role in strations and role plays and interac- with the mission of helping people to Project UDAY, a comprehensive dia- tive exercises and games. The help themselves. THE MAZADA PHARMA GUIDE  1May - 15 May 2016 79

PHARMA ARTICLE Phase-3 trials of tildrakizumab in patients with moderate-to-severe plaque psoriasis meet primary endpoints un Pharma has announced further validating the importance trolled, multicenter studies that two pivotal phase-3 clini- of the role of IL-23 in psoriasis. designed to demonstrate efficacy Scal trials evaluating the effi- We are encouraged by these of tildrakizumab in moderate-to- cacy and safety of the investiga- results and the potential to provide severe plaque psoriasis compared tional IL-23p19 inhibitor antibody a new treatment option to patients to placebo and comparative drug tildrakizumab (MK-3222) in with moderate-to-severe plaque and to assess safety and tolerabil- patients with moderate-to-severe psoriasis, a disease that often ity. Psoriasis Area Severity Index plaque psoriasis met their primary takes both a physical and emo- (PASI) and Physician Global endpoints for both evaluated tional toll on their lives,” stated Assessment (PGA) were the pri- doses. DilipShanghvi, managing director, mary endpoints in the studies. A The co-primary efficacy end- Sun Pharma. “We would like to PASI score is a measure of psori- points of the placebo controlled thank the over 1,800 patients who atic plaque redness, scaling and studies (MK-3222-010 and MK- participated as well as the investi- thickness and extent of the 3222-011) were: the proportion of gators at more than 200 clinical involvement in each region of the participants with Psoriasis Area sites.” body. Treatment efficacy is often Sensitivity Index 75 (PASI 75) “While there are existing treat- measured by reduction of PASI response at week 12 compared to ment options for psoriasis, many from baseline (i.e. 75 per cent placebo and the proportion of par- patients continue to struggle with reduction is known PASI 75,) a 90 ticipants with a Physician's Global the debilitating impact this chronic per cent reduction is known as Assessment (PGA) score of clear disease can have on their bodies, PASI 90 and PASI 100 is total or minimal with at least a 2 grade their lives and their families,” said clearance of skin disease. PGA reduction from baseline at week Kim Papp, MD, clinical trial inves- measures lesion thickness, erythe- 12 compared to placebo. The tigator and president, Probity ma and scaling across all of a overall safety profile of tildrak- Medical Research, Inc. patient’s psoriasis lesions in order izumab in both phase-3 clinical tri- “Tildrakizumab works by selective- to determine the disease activity als was consistent with the safety ly targeting IL-23, specifically the on a six-point scale from “clear” to data observed in previously p19 component of the cytokine. “severe.” reported studies. Blocking this key cytokine helps Sun Pharmaceutical Industries The second study (MK-3222- control the pathogenic cells Ltd.’s wholly owned subsidiary, 011) also included an etanercept responsible for the inflammatory acquired worldwide rights to comparator arm, with a key sec- process of psoriasis. These new tildrakizumab from Merck in 2014. ondary endpoint comparing tildrak- data are encouraging and support Funded by Sun Pharma sub- izumab and etanercept on PASI the potential of tildrakizumab as a sidiary, Merck is responsible for 75 and PGA. Tildrakizumab new treatment option for patients.” the completion of phase-3 trials in 200mg was superior to etanercept The preparations for submis- patients with mild-to-moderate on both PASI 75 and PGA end- sion of a Biologics License plaque psoriasis and, as appropri- points at week 12, while the 100 Application to the US Food and ate, submission of a Biologics mg dose showed superiority to Drug Administration are proceed- License Application to the United etanercept on PASI 75 only. ing. The detailed findings from the States Food and Drug “Tildrakizumab is the first IL- phase-3 clinical trials will be pre- Administration (FDA). Merck is 23p19 inhibitor to demonstrate sented at upcoming scientific also responsible for manufacturing positive results in phase-3 clinical meetings. finished goods to support Sun trials for the treatment of moder- Tildrakizumab phase-3 studies Pharma’s initial product launch. ate-to-severe plaque psoriasis, are randomized, placebo-con- Post-approval in the US, Sun 80 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

PHARMA ARTICLE Pharma will be responsible for all pain of knee osteoarthritis (OA) entire NDA submission. In other regulatory activities, associated with bone marrow addition, Fast Track designated including subsequent submis- lesions (BMLs). There is currently products are eligible for Priority sions, pharmacovigilance, post no product approved specifically Review at the time of NDA approval studies, manufacturing for this indication. submission. AXS-02 (disodium and commercialisation of the “We are pleased that the FDA zoledronatetetrahydrate) is a approved product. Sun Pharma has granted Fast Track status for potent osteoclast inhibitor being will also be responsible for all reg- AXS-02 for the treatment of knee developed as an oral, targeted, ulatory, pharmacovigilance, post- OA pain associated with bone non-opioid, potentially first-in- approval studies, manufacturing, marrow lesions,” said Herriot class therapeutic for chronic pain. and commercialization of Tabuteau, M.D., chief executive AXS-02 has a high affinity for approved products for all non-US officer of Axsome. “This regulatory bone mineral, and reduces markets. Merck is eligible to decision confirms that this novel osteoclast activity by inhibiting the receive milestone payments, indication represents an unmet farnesyl pyrophosphate synthase and royalties on sales of tildrak- medical need, and complements (FPPS) enzyme. AXS-02 is being izumab. the FDA Special Protocol developed for the treatment of Tildrakizumab is an investiga- Assessment received for our complex regional pain syndrome tional humanized, anti-IL-23p19 recently initiated phase 3 trial.” (CRPS), the pain of knee monoclonal antibody designed to AXS-02 is a potent osteoclast osteoarthritis (OA) associated selectively block the cytokine IL- inhibitor being developed as an with bone marrow lesions (BMLs), 23. Evidence from human genet- oral, targeted, non-opioid, and chronic low back pain ics studies suggest that inhibition potentially first-in-class therapeu- (CLBP). Phase 3 trials are of IL-23 may provide an approach tic for chronic pain. AXS-02 is underway with AXS-02 in CRPS for the treatment of some inflam- currently being evaluated in a and knee OA associated with matory conditions. phase 3 trial, the COAST-1 study, BMLs, and a Phase 3 trial is Psoriasis is a chronic immune for the treatment of knee OA planned in CLBP. AXS-02 is an disease that appears on the skin. associated with BMLs. This study investigational product candidate It affects an estimated 7.5 million is being conducted pursuant to an not approved by the FDA. people in the US and approxi- FDA Special Protocol Knee OA is a disorder charac- mately 125 million people world- Assessment. terized by periarticular bone wide. It is a non-contagious The FDA’s Fast Track designa- changes, progressive loss of disorder that speeds the growth tion programme is designed to aid articular cartilage, joint space cycle of skin cells and results in in the development and expedite narrowing, and eventual total joint thick scaly areas of skin. The the review of drugs that are failure. It is clinically manifested most common form of psoriasis, intended to treat serious or life- by knee pain, significant physical called plaque psoriasis, appears threatening conditions. In order to disability, and reduced quality of as red, raised areas of skin receive Fast Track designation, a life. BMLs are regions of covered with flaky white scales, product must also demonstrate increased signal intensity on which may be itchy and painful the potential to address an unmet magnetic resonance imaging and can crack and bleed. medical need. Fast Track (MRI) of the knee in patients with Currently, there is no cure for designation provides greater knee OA. BMLs are strongly psoriasis. access to, and more frequent associated with the presence and Fast Track status for AXS-02 to communication with, the FDA severity of knee pain, and predict treat pain of knee osteoarthritis throughout the entire drug disease severity and structural associated with BMLs development and review process, progression in patients with knee Axsome Therapeutics, Inc., a with the goal of getting important OA, based on published studies. clinical-stage biopharmaceutical new drugs to patients more rapid- Results of epidemiological company developing novel thera- ly. It also provides the opportunity studies suggest that there are pies for the management of CNS to submit sections of a New Drug approximately 7 million disorders, received from the US Application (NDA) on a rolling symptomatic patients in the Food and Drug Administration basis, where the FDA may review United States, 50 years of age (FDA) Fast Track designation for portions of the NDA as they are and older, with radiographic knee AXS-02 for the treatment of the received instead of waiting for the OA and BMLs. THE MAZADA PHARMA GUIDE  1May - 15 May 2016 81

PHARMA FOOD ARTICLE USDA offers $6 million for antimicrobial resistance research he U.S. Department of cation and outreach resources shutdown the current reporting sys- Agriculture (USDA) is making (including web-based resources) tems for restaurant inspections T$6 million available for that can be adapted by users used by Larimer and Weld counties. research into antimicrobial resist- across the food chain, including pol- Larimer rates restaurants from ance and has set an Aug. 3 dead- icy makers, producers, processors, excellent to unfit, and Weld uses A line for grant proposals. The fund- retailers and consumers. to F grades. ing comes from the Agriculture and Design and conduct studies that The new law empowers the Food Research Initiative authorized evaluate the impact and efficacy of Colorado Department of Public by the 2014 Farm Bill and is admin- proposed research, education and Health and Environment (CDPHE) istered by USDA’s National Institute extension/outreach interventions on to impose a uniform system for of Food and Agriculture (AFRI). antimicrobial resistance across the public reporting on local govern- Through our Antimicrobial food chain, from primary producers ments in exchange for increases in Resistance Action Plan, USDA is to primary consumers. annual licensing fees. leading the way to better under- Since 2009, more than $82 mil- At the behest of the powerful stand how antibiotic resistance lion in food safety research and Colorado Restaurant Association, develops, find alternatives to antibi- extension grants has been awarded both Democrat and Republican law- otics, and educate people on prac- through AFRI, including $3.4 million makers accepted language in the tices that reduce the need for in fiscal year 2015 for antimicrobial bill that specifically says the “uni- antibiotics,” Agriculture Secretary resistance. form system” of reporting “must not Tom Vilsack said in a news release Previously funded projects summarize the results of the Monday. “The research projects include a State University of New inspection with a letter, number, or funded through this announcement York project evaluating critical con- symbol grading system, or a similar will help us succeed in our efforts to trol points in dairy farm operations oversimplified method of quantifying preserve the effectiveness of antibi- and a Texas A&M University project results.” otics and protect public health.” to develop science-based decision That means the A-F letter grade Applications for research funding aids related to antibiotic steward- system, used from New York to must address one or more of the ship. California, would be banned in following: Colorado bans letters, numbers, Colorado, a state that is highly Develop novel systems symbols on restaurant reports dependent on tourism. And the dic- approaches to investigate the ecol- He does not make much use of tates don’t stop there. ogy of microbial resistance the veto power and he is the former Weld County Commissioner microbes and gene reservoirs in the owner of a popular Denver brew Mike Freeman told local media that environment in animals, in crops, in pub. Both of those facts make it HB 16-1401 would leave the state’s food products, or in farm-raised unlikely that Gov. John fastest growing county paying aquaculture products. Hickenlooper will veto popular almost three quarters of the inspec- Develop, evaluate and imple- House Bill 16-1401, which ups fees tion costs while restricting how it ment effective and sustainable and sets new policy for restaurant can communicate with residents. resources and strategies, to include inspections. Since it went to A-F reporting, Weld alternative practices, techniques, HB 16-1401, which first passed County has seen a 100 percent technologies or tools that mitigate the Democratically-controlled increase in public accessing the emergence, spread or persistence Colorado House on a 42 to 11 vote scores and a 50 percent reduction of antimicrobial resistant pathogens with 12 excused, cleared the GOP- on inspection failures. within the agricultural ecosystem, in controlled Senate on a 23 to 11 The first increase in state licens- animals, in crops and in food. vote with one excused on April 28. ing fees for inspections would take Identify critical control points for The Colorado Legislature’s session effect on Jan. 1, 2017. A second fee mitigating antimicrobial resistance is scheduled to end May 11. increase on Jan. 1, 2018, and a in the pre- and post-harvest food Some Northern Colorado offi- third increase on Jan. 1, 2019, have production environment. cials have asked Hickenlooper to strings attached. The state is Design innovative training, edu- veto the new law, which will likely required to implement the uniform 82 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

PHARMA FOOD ARTICLE reporting system in order for the are likely coming soon. The U.S. sharing, and to the extent possible, second increase to take effect. The and New Zealand have had an leverage resources so that the third increase will take effect only if agreement that their systems are agencies can better meet their food establishment plans and comparable since 2012. public health objectives.” specifications and Hazard Analysis The Food Safety Systems The use of an agreement over Critical Control Point plans are Recognition Arrangement between comparable systems is pretty much being approved within 14 working the U.S. and Canada lays down a the same way the U.S. Department days. framework for regulatory coopera- of Agriculture (USDA) has gone Inspection reports for restaurants tion between the neighboring coun- about approving countries for in the Denver area , ski resort ties that runs the gament from sci- importing meat into the U.S., and towns and most other Colorado entific collaboration to outbreak visa versa. counties are found online, but critics response. The FDA, Public Health Government agreements, say the language is too often filled Agency of Canada and the especially those that clear away with legal jargon and vague and Canadian Food Inspection Agency overlap and duplication, are usually incomplete statements. About are all parties to the agreement. met with favor by producers and 11,000 food and beverage FDA needs foreign help in manufacturers. establishments will be covered by implementing the historic Food “This recognition arrangement the new law. Safety Modernization Act, which will significantly benefit both con- US and Canada agree their food calls for imposing the same stan- sumers and the produce industry by safety systems are comparable dards on foreign food as required of facilitating trade, reducing redun- The United States and Canada domestic sources. dant regulatory requirements and have comparable food safety The agreement sets up a U.S.- enabling even greater confidence in systems, a fact that has now been Canada Regulatory Cooperation the produce that is traded between officially recognized by the U.S. Council to help the two countries our two countries,” said Jim Gorny, Food and Drug Administration “better align their food safety regu- vice president for food safety and (FDA). The food safety systems for latory systems, reduce unnecessary technology for the American-based Australia and the European Union duplication, enhance information Produce Marketing Association. THE MAZADA PHARMA GUIDE  1May - 15 May 2016 83

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PHARMA MACH. ARTICLE Opportunities in life-cycle microbiology testing services terigenics International LLC, a ture, customer oriented service and of tenofovir that has demonstrated leading global provider of commitment to quality,” continued high antiviral efficacy similar to and Scontract sterilization, gamma Mulhern. “We believe that the fit is at a dose less than one-tenth that of technologies and medical isotopes, perfect with Sterigenics and look Gilead's Viread (tenofovirdisoproxil- and a portfolio company of Warburg forward to working together on our fumarate, TDF). TAF has also Pincus and GTCR, announced that shared mission of improving global demonstrated improvement in surro- it has acquired Nelson Laboratories, public health.”“Sterigenics will be a gate laboratory markers of renal Inc., the largest US provider of life- great partner, and will provide the and bone safety as compared to cycle microbiology testing services global access and ongoing invest- TDF in clinical trials in combination for the medical devices, pharma- ment necessary to ensure long-term with other antiretroviral agents. Data ceutical and tissue industries. Terms growth of the lab services busi- show that because TAF enters cells, of the transaction were not dis- ness,” said Jeffery Nelson. “They including HIV-infected cells, more closed.Nelson Labs employs 570 are a global leader in contract steril- efficiently than TDF, it can be given professionals, including more than ization and sterility assurance serv- at a much lower dose and there is 300 scientists and 60 registered and ing the same markets as Nelson 90 per cent less tenofovir in the specialist microbiologists. With 85 Labs. This is an excellent cultural fit, bloodstream. labs running out of five corporate and I’m excited for the opportunities 'As the first new HIV treatment buildings in Salt Lake City, they this will bring for our teams and our backbone approved by the FDA in work with more than 3,000 client customers throughout the more than a decade, Descovy rep- companies in 57 countries, provid- world.”PriceWaterhouseCoopers resents an important evolution in ing more than 400 microbiological served as accounting advisors and HIV care. As part of a single tablet and analytical tests.All Nelson Labs Holland & Knight LLC provided legal regimen or partnered with a third operations will remain in Salt Lake counsel to Sterigenics International. agent, the components of Descovy City and be combined with D.A. Davidson & Co. served as offer patients a simple and effective Sterigenics’ existing microbiological financial advisors, Tanner LC served combination with a safety profile and analytical testing and consul- as accounting and tax advisors and that has the potential to improve tancy - SteriPro Labs. Moving for- Parsons, Behle& Latimer provided health,' said Norbert Bischofberger, ward, the combined entities will go legal counsel to Nelson Labs. PhD, executive vice president, to market under the Nelson Labs TAF-based HIV therapy, Descovy research and development and brand name and operate as a Gilead Sciences, Inc. announced chief scientific officer, Gilead standalone business unit within that the US Food and Drug Sciences. 'With today's approval, Sterigenics International. Jeffery Administration (FDA) has approved Gilead is now able to offer patients Nelson will serve as president of Descovy (emtricitabine 200 and providers in the United States a Nelson Labs and together, with the mg/tenofoviralafenamide 25 mg, range of options from our TAF Sterigenics contract sterilization F/TAF), a fixed-dose combination based-portfolio, which is designed business, will create the largest fully for the treatment of HIV. Descovy is to help address the diverse needs integrated global sterilization and indicated in combination with other of HIV patients worldwide.' lab services firm in the world.“This antiretroviral agents for the treat- The approval of Descovy is sup- is a significant strategic acquisition ment of HIV-1 infection in adults and ported by 48-week data from two to help build out Sterigenics’ lab paediatric patients 12 years of age pivotal phase 3 studies (Studies 104 testing and service capabilities on a and older. Descovy is not indicated and 111) in which the F/TAF-based global scale, enabling us to better for use as pre-exposure prophylaxis regimen (administered as Genvoya; serve our multinational customers,” (PrEP) to reduce the risk of sexually elvitegravir 150 mg/cobicistat 150 said Michael Mulhern, CEO of acquired HIV-1 in adults at high risk. mg/emtricitabine 200 mg/tenofovi- Sterigenics International. “We will Descovy has a boxed warning in ralafenamide 10 mg, E/C/F/TAF) continue to explore additional its product label regarding the risks met its primary objective of non- expansion opportunities for our lab of lactic acidosis/severe inferiority compared to a F/TDF- services to meet our customers’ hepatomegaly with steatosis, and based regimen (administered as growing needs.” post treatment acute exacerbation Stribild; elvitegravir 150 mg/cobicis- “We are incredibly impressed of hepatitis B. tat 150 mg/emtricitabine 200 with Nelson Labs’ leadership, cul- TAF is a novel targeted prodrug mg/tenofovirdisoproxilfumarate 300 86 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

PHARMA MACH. ARTICLE mg, E/C/F/TDF) among treatment done for each of its other HIV med- other forms of therapy, and suffered naïve adult patients. Tests of certain ications, to provide discounts to from symptoms including pain, renal and bone laboratory parame- state AIDS Drug Assistance fatigue, anorexia and wasting. The ters favored the F/TAF-based regi- Programs (ADAPs) that will help patients treated in the phase III men over the F/TDF-based regi- ensure access to Descovy for study were considered to represent men. The approval also is support- patients who receive medications a large patient population that is ed by a phase 3 study (Study 109) through these programmes. physically and emotionally exhaust- evaluating the F/TAF-based regimen True human monoclonal antibody ed from the disease and treatment- (administered as Genvoya) among Xilonix in advanced colorectal can- related toxicities. virologically suppressed adult cer XBiotechInc, a clinical-stage bio- 'XBiotech is encouraged by patients who switched from F/TDF- pharmaceutical company, CHMP's action to grant accelerated based regimens. In the study, the announced that the Committee for review of Xilonix,' said John F/TAF-based regimen was found to Medicinal Products for Human Use Simard, chairman, chief executive be statistically non-inferior to the (CHMP) of the European Medicines and founder of XBiotech. 'There is F/TDF-based regimens and demon- Agency (EMA) has granted acceler- an urgency to provide advanced col- strated improvements in certain ated review for Marketing orectal cancer patients with access bone and renal laboratory parame- Authorisation of Xilonix, the compa- to new treatments that have been ters compared to the F/TDF-based ny's first-in-class True Human mon- developed with their specific needs regimens. Additionally, the approval oclonal (IgG1k) antibody treatment in mind.' is supported by data from phase 3 for advanced colorectal cancer. In the US, Xilonix has received studies evaluating the F/TAF-based The CHMP grants accelerated Fast Track designation by the Food regimen (administered as Genvoya) review for medicines deemed to be and Drug Administration (FDA) among virologically suppressed of public health importance and that for the treatment of advanced adults with mild-to-moderate renal represent therapeutic innovation. colorectal cancer. impairment and among treatment The accelerated review procedure Colorectal cancer is the second naïve adolescents. Finally, bioequiv- allows the CHMP to grant an leading cause of malignancy in the alence studies demonstrated that opinion two months earlier than the industrialized world. The incidence Descovy achieved the same drug normal 210-day procedure. With this of colorectal cancer increases with levels of TAF and emtricitabine in action, a decision on Xilonix's economic development and aging, the blood as Genvoya. approval could come as early as hence incidence is rising worldwide. Gilead's US Advancing Access third quarter 2016. In Europe, approximately 470,000 programme provides assistance to Xilonix is XBiotech's lead True patients will be diagnosed with col- appropriate patients in the United Human therapeutic antibody and a orectal cancer in 2016, and half of States who are uninsured, underin- potential breakthrough for patients this number will progress and ulti- sured or who need financial assis- with advanced colorectal cancer. mately succumb to the disease. tance to pay for their medications, Xilonix specifically targets and Disease progression is associated including Descovy. neutralizes interleukin-1 alpha with significant morbidity, functional The programme offers informa- (IL-1a), a molecule known to pro- impairment and failure of multiple tion and assistance for patients, mote angiogenesis (the growth and therapies often with including: Access to agents who spread of tumors), as well as substantial toxicities. Patients with can provide information related to mediate symptoms such as meta- advanced disease are thus sympto- coverage and insurance-related bolic dysregulation (e.g., loss of matic and intolerant to further questions. weight and muscle mass), fatigue treatment-related morbidity. New The Advancing Access Copay and anxiety associated with anti-cancer options are needed for Coupon Program, which provides advanced cancer. patients suffering from advanced co-pay assistance for eligible XBiotech recently received colorectal cancer.Unlike antibodies patients with private insurance who validation of its Marketing found in other therapies, XBiotech's need assistance paying for out-of- Authorisation Application (MAA) for True Human(TM) antibodies are 100 pocket medication costs.The Xilonix based on results of a phase percent human and derived from Advancing Access Patient III study, which showed a 76 per healthy people with natural immuni- Assistance Program and Truvada cent relative improvement in ty to heal and protect Medication Assistance Program, response rate in patients treated others. By rethinking the approach which will provide Gilead medica- with the antibody, as compared to to antibody therapy, XBiotech devel- tions at no charge for eligible placebo (p=0.0045). Patients treated oped a proprietary technology to patients with no other insurance in the phase III study had colorectal identify, isolate and manufacture options.Additionally, Gilead is work- tumors that were metastatic or inop- human antibodies derived from the ing closely with the ADAP Crisis erable, had failed all recommended body that finally work in harmony Task Force, as the company has forms of chemotherapy and most with it. THE MAZADA PHARMA GUIDE  1May - 15 May 2016 87

IMPORT PRICES GLOBAL CHEMICAL IMPORT PRICES PRODUCTS LANDEDAT ORIGIN RS/TON PRODUCTS LANDEDAT ORIGIN RS/TON Bromine-element/ Vizag S Jordan 164832 Para Terilary Butyl Phenol jnpt se taiwan 96056 Crude lodine 99.5 Percent Jnpl Se Chile 1568257 Para Terilary Butyl Phenol jnpt se korea 94778 lodine Jnpl Se Japan 1442280 para-toluidine Vizag S Germany 183255 lodine Solution 16.00% Jnpl Se Korea 1223483 paraxylene (in Bulk ) kolkata Singapore 54431 Liquid Bromine Jnpl Se Israel 144228 Penta Ethylene Hexa Amine jnpt se Japan 241842 Bright Yellow Crude Sulphur Vizag S Bahrain 7017 Phenol jnpt se taiwan 58497 Bright Yellow Sulphur Crude Paradee Qatar 6508 Phenol jnpt se Singapore 68174 Bright Yellow Sulphur Crude Tuticor UAE 7634 Phenol in Bulk kolkata Thailand 58230 Carbon Black - Black Pearl Anklesh USA 1124054 phenyl Ethyl Aicohol Chennai China 264516 Carbon Black Jnpt Se Egypt 52815 Phthalic Anjydrude jnpt se israel 44590 Carbon Black Fw 182 Beads Jnpt Se Germany 791148 Phthalic Anjydrude jnpt se Russia 41556 Carbon Black N326 Sanand Korea 45439 Poly Ethylene Glycol (Peg 400 jnpt se Iran 56090 Compressed Gas N.o.s Chennai USA 61112459 Polymethylene - Polyphenylene Chennai China 77458 Helium Refrlgerated Liquid Class Jnpt Se Qatar 2945700 Polymethylene - jnpt se Japan 76981 Helium Refrlgerated Liquid Jnpt Se UAE 2336868 Polymethylene Polyphenyl jnpt se Japan 77608 Selenium Metal Powder 99.9% Jnpt Se Japan 920312 patassium Citrate Usp jnpt se Germany 380959 Silicon Jnpt Se Australia 161398 Propylene Glycol jnpt se korea 82428 Silicon 2202 Grade Jnpt Se Hongkong 147830 Propylene Oxide Dahej S Saudi 82961 Silicon Metal Jnpt Se Korea 107141 Purified Isophthalic Acid Mundra taiwan 71531 Silicon Metal 553, Ludhian China 104652 Purified Terephthalic Acid jnpt se Iran 40047 Silicon Metal Grade 553 Jnpt Se S.africa 110566 Purified Terephthalic Acid jnpt se Thailand 37310 Yellow Phosphorous Jnpt Se Vietnam 194836 salicylic Acid jnpt se China 101646 Calcium Pferrocal Wire Kolkata Netherland 543141 salicylic Acid (Purified grade jnpt se France 149874 Lithium Metal 98 Pct min Jnpt Se China 4009801 Sodium Ascorbate Chennai China 253988 Mercury Hg Min 99.99% Jnpt Se Indonesia 1820020 Sodium Saccharin 8-16 Mesh jnpt se China 649026 Sodium Metal Adc Chennal France 145945 Sorbic Acid jnpt se Germany 554934 Sulphuric Acid Vizag S Japan 2926 Saya Lecilhin Nagpur Argenlina 38778 Sulphuric Acid In Bulk Paradee Kore rep 1924 Styrene Monomer kandla Saudi 73659 Nonyl Phenol jnpt se taiwan 72114 Styrene Monomer Vizag S Singapore 74036 normal butanol jnpt se malaysla 36459 Styrene Monomer Mumbai Spain 67608 N-prpyl Acetate kandla USA 62184 Tert.-butylamine jnpt se Belgium 273209 N-prpyl Bromide Chennai USA 220645 Terliary Butanol Chennai China 65400 Octiamethyl Cyclotetra Chennai Thailand 201169 Tetra Hydro Furan Vizag S taiwan 105252 orthanilic Acid Ahmedob China 295324 Toluene Mumbai Spain 42292 Orto Amino Phenol jnpt se China 275223 Toluene Di Isocyanate Cosmonate jnpt se Japan 96737 Ortho Chloro Benzyl Cyanide jnpt se China 230078 Toluene In Bulk Vizag S korea 42578 Ortho Chloro Toluene Dadri A Germany 91968 Tranexamic Acid Ip(list 4 Sir.no jnpt se China 4564342 Ortho Ethyl Aniline jnpt se China 253423 Trl Ethanol Amine (tea 85% jnpt se Iran 63016 Ortho Terliary Butyl Phenol jnpt se taiwan 104912 Trl phenyl Phospine 99.5% jnpt se China 442809 Ortho Toluene Sulphonamide Vizag S China 271286 Tridecanol (tridecyl Alcohol jnpt se Japan 157964 Ortho tolyl Acetic Acid Vizag S China 378278 Triethanolamine 99 (tea 99 kolkata Thailand 69487 ortho-aminophenol Ahmedob China 288087 Triethanolamine 99% jnpt se malaysla 74174 Orthoxylene . Mumbai Iran 44654 Triethyl Orthoformate Chennai China 149193 Orthoxylene 98 Pct Mumbai Singapore 43148 Triethylene Tetramine jnpt se Saudi 262279 Oxytetracycline Hydrochlorid jnpt se China 654341 TriethyleneTetramine jnpt se Netherland 250702 Para Amino Phenol krishna China 142854 Trimellitic Anhydride jnpt se China 145602 Para Anisidne jnpt se China 152395 Vinyl Acetate Monomer kandla Singapore 64559 Para Benzoquinone jnpt se China 571418 Vinyl Chloride Monomer Tuticor France 43908 Para Chloro Methyl Benzoic Acid jnpt se China 2111910 Vinyl Chloride Monomer Tuticor Qatar 44569 Para Hydroxy Benzoic Acid jnpt se China 179849 Vinyl Sulphone Ester 96% Min jnpt se China 158049 Para Hydroxy Benzoic Acid Hyderab Japan 182574 Vitamin E Acetate Oil Chennai Germany 618867 Para Nitro Chloro Benzene jnpt se China 41208 88 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

EXPORT PRICES INDIAN CHEMICAL EXPORT PRICES PRODUCTS LANDEDAT ORIGIN RS/TON PRODUCTS LANDEDAT ORIGIN RS/TON Liqutd Bromine Plpavav China 161864 Barium Chioride Dihydrate Crystal Chennal Alabama 53579 Insoluble Slphur Tughiak Iran 111626 Calcium Bromide Mundra Korea 95850 Sulphur in Lumps Mundra Djiboutl 15737 Calcium Phosphoryl Choline Chlori Jnpt Spain 1189032 Sun Petroche Jnpt Se China 105712 Copper Oxychloride Jnpt Thailand 218455 carbon Black Grade N 330 Cochin Srilanka 45218 Copper Oxychloride Ahmedab France 228865 Carbon Black Grade N 660 Cochin korea 41832 Copperlodide Jnpt USA 1434240 Carban Black Grade N 220 Mundra Vletnam 46015 Cupric Chloride Dihydrate Ahmedab Germany 173735 Carban Black Grade N 339 Mundra Philippine 38180 Cuprous Chioride Ahmedab Belgium 302904 Red Phosphorus Jnpt Slovenla 407633 Lithlum Bromide Solution Inhibite Pune Ta Iran 450000 Red Phosphorus tuticor USA 360908 Lithium Bromidesolution Jnpt China 247046 Phosphorus Pentaoxide Jnpt Spain 114533 Potassium Lodide Bp Jnpt Netherland 1294800 phosphorus Pentaoxide Jnpt USA 178784 Potassium Lodide Bp/usp Jnpt Vietnam 1379958 50% Periodic Acid Solution Jnpt USA 1122160 Sadium- Bromide Solution Jnpt Saudi 77094 Hydrobromic Acid 48% Mundra China 83161 Sadium- Bromide Solution Jnpt Oman 76326 Hydrobromic Acid 48% Mundra korea 83488 Stannous Chioride Dijyadrate Lot N Jnpt Italy 834043 Hydrobromic Acid 48% Mundra Talwan 77934 Aquafit ('we Inted To Claim Rewa Jnpt Ghana 104145 Slilcomix - Micro Silica, Vizags Qatar 9123 Calcium lodate Jnpt Brazil 1067853 Phosphorus PentasulphIde 98% Jnpt Russla 100964 Calcium Iodate Jnpt Italy 1121496 Phosphorus PentasulphIde 98% Jnpt S.africa 102669 Calcium Iodate Jnpt U K 1135440 Caustic Potash Flakes Pkd 25kg Ba Chennal UAE 55046 Potassium lodate Jnpt Kenya 1092280 Caustic Soda Flakes Anklesh Srilanka 30462 Potasslum lodate Jnpt Eritrea 1660000 Caustic Soda Flakes Plpavav Zaire 28884 Sodium Formaldehyde Sulphoxylate Baroda Japan 126595 Caustic Soda Flakes Mundra kenya 29548 Zinc Formaldehyde Sulphoxylate Jnpt China 265164 Zinc Oxide Baroda Australia 126393 Redusynth 25tm Nagpur S.africa 19854 Zinc Oxide Baroda Thailand 115438 Solachrome B Basic Chromium Sulph Jnpt Brazil 53341 Zinc Oxide Mundra Vietnam 105666 Basic Chromium Sulphate Vizag S Brazil 54543 Zinc Oxide Baroda Japan 142328 Basic Chromium Sulphate Vizag S China 45679 Zinc Oxide Mundra Philippine 95417 Bordeaux Mixture Tech Jnpt Spain 131214 Aluminium Hydraoxide Jnpt Indonesla 15589 Cobalt Sulphate Baroda China 349593 Aluminium Hydraoxide Jnpt kenya 19490 Copper Sulphate Tuticor Bahrain 113947 Aluminium Hydraoxide Jnpt Talwan 15269 Nickel Sulphate Goa Sea Korea 148877 Aluminium Hydraoxide Chennal Malaysia 15399 Nickel Sulphate Goa Sea Belgium 140672 Calcined Alumina Jnpt B'desh 42434 Tri Basic Lead Sulphate Jnpt Se Russia 133782 Calcined Alumina Jnpt China 27224 Tri Basic Lead Sulphate Jnpt Saudi 125337 Calcined Alumina Jnpt korea 28052 Tri Basic Lead Sulphate Jnpt S.africa 136076 Calcined Alumina Jnpt Thailand 37820 Colcium Hypophosphite Jnpt Indonesia 528902 Sandy Calcined Metallurgical Grad Vizags UAE 16069 Ferric Pyro Phosphate Fcc Bangalo China 397196 Chromium Trixide Anhydrous Vizags Singapore 161664 Ferric PyroPhosphate Baroda Philippine 507806 Manganese Oxide Mundra Indonesla 28454 Ferric Pyro Phosphate Fcc Baroda Israel 504487 manganese Oxide Powder Nagpur Russla 30513 Tribasic Lead Sulphate Chennai Saudi 127373 Iron Oxide Dry Powder Grade Vizags Saudi 16400 Barium Carbonate Lsp Krishna Spain 24613 Iron Oxide Dry Powderiron Oxide Powde jaipur lraq 16068 Colcium Carbonate Fmb grade Petrapo B'desh 25992 Synthetic Iran Oxide Pigment Red tuticor USA 49208 Sodium Cyanide Jnpt Iran 170000 Titanium Dioxide Cochin USA 119171 Magnesium Silicate Packing Mundra Nigeria 11665 Titanium Dioxide anatase tuticor Nigerla 146080 Sodium Silicate Lumps Chennai UAE 16738 Upgraded BeneticIated limenite tuticor Japan 46865 Potassium Dichromate Vizag S Belgium 137155 upgraded BeneticIated limenite tuticor Malaysia 61809 Potassium Permanganate Crystailin Jnpt Turkey 145418 Lead Oxide Litharge Chennal Saudi 125796 Potassium Permanganate Technical Jnpt Germany 147166 Lead Oxide Red (red Lead Hyderab UAE 125989 Sodium Permanganate Jnpt USA 164507 Litharge Plpavav korea 129171 Sodium Selenite Jnpt Brazil 584320 Red Lead (lead Oxide) Cochin B'desh 121443 Zinc Phosphide Zinc Phosphide Jnpt Vletnam 270487 Antimony Trioxide Jnpt Se Egypt 366186 Sodium Hydride Hyderab Japan 519173 Chuna Mundra Saudi 59344 Mercury Ammonium Chloride Jnpt Pakistan 3192846 Aluminium Fluoride tuticor UAE 64085 Sodium Amide (Powder ) Hyderab France 383671 Boron Trifiuoride Jnpt Talwan 579608 Sodium Amide (sodamide Hyderab Italy 351477 Boron Trifiuoride Jnpt USA 428767 Sodium Amide Hyderab USA 351920 52% Caicum Bromide Solution Pack Ahmedab UAE 94203 Sodium Tertiary Butoxide sodium Hyderab Belgium 295347 Aluminium Chioride panki l Australia 45980 THE MAZADA PHARMA GUIDE  1May - 15 May 2016 89

IMPORT PRICES IMPORT STATISTICS PRODUCTS PORT SOURCE QTY.UNIT VALUE IN RS $/UNIT ACYCLOVIR IP JNPT SEA CHINA 2.00 MT 3995963 31713.97 AMIKACIN SULPHATE IP JNPT SEA CHINA 0.62MT 4417681 114019.37 AMOXICILLIN TRIHYDRATE BP CHENNAI SEA SINGAPORE 5.00MT 9355630 29700.48 AMOXICILLIN TRIHYDRATE BP (COMPACTED CHENNAI SEA CHINA 20.00MT 33299700 26428.41 AMOXICILLIN TRIHYDRATE COMPACTED IP JNPT SEA CHINA 30.00MT 48518654 25616.83 AMOXICILLIN TRIHYDRATE IP JNPT SEA CHINA 3.00MT 4947384 26260.03 AMOXICILLIN TRIHYDRATE IP JNPT SEA CHINA 5.00MT 8213926 26159.08 AMOXICILLIN TRIHYDRATE BP JNPT SEA CHINA 5.40MT 9110798 26780.63 AMOXICILLIN TRIHYDRATE IP JNPT SEA CHINA 17.00MT 2845631 26108.44 AMOXICILLIN TRIHYDRATE IP JNPT SEA CHINA 2.00 MT 3364221 26785.19 ASCORBIC ACID IP JNPT SEA CHINA 40.50MT 8534025 3333.02 ASPARTAME FCC/USP JNPT SEA CHINA 4.00 MT 2672461 10605.08 AZITHROMYCIN IP JNPT SEA CHINA 5.38 MT 27378598 79992.04- AZITHROMYCIN IP JNPT SEA CHINA 7.50 MT 39472016 80800.00 AZITHROMYCIN IP JNPT SEA CHINA 0.50 MT 2681418 85124.44 AZITHROMYCINIP JNPT SEA CHINA 2.50 MT 13757218 86355.08 CALCIUM-D-PANTOTHENATE IP JNPT SEA UK 7.00 MT 6859314 15553.97 CEFALEXIN MONOHYDRATE BP JNPT SEA CHINA 2.00 MT 5962232 47319.37 CEFALEXIN MONOHYDRATEB.P JNPT SEA CHINA 11.00MT 32094568 46312.54 CHLORAMPHENICOL IP JNPT SEA CHINA 3.50 MT 12279035 52675 CLARITHROMYCIN IP JNPT SEA CHINA 0.50MT 4598530 146450 D-CALCIUM PANTOTHENATE IP CHENNAI SEA CHINA 10.00 MT 10148480 16160.03 DOXYCYCLINE HYCLATE BP/IP JNPT SEA CHINA 3.00 MT 8372496 44439.97 DOXYCYCLINE HYCLATE IP JNPT SEA CHINA 5.00 MT 14394985 45843.95 DOXYCYCLINE HYCLATE IP JNPT SEA CHINA 1.00 MT 2831535 44945.08 GENTAMYCIN SULPHATE IP JNPT SEA CHINA 0.67 MT 4622789 110429.62 GENTAMYCIN SULPHATE IP JNPT SEA CHINA 1.00 MT 6921107 110429.62 GLICLAZIDE BP/IP JNPT SEA CHINA 1.00 MT 4963140 78780 GLICLAZIDE BP/IP CHENNAI SEA CHINA 6.00 MT 29684304 78529.84 GLICLAZIDE BP/IP JNPT SEA CHINA 1.00 MT 4867695 77265.08 GLICLAZIDE BP JNPT SEA CHINA 1.00 MT 5885775 93425.08 GLICLAZIDE IP/BP JNPT SEA CHINA 1.00 MT 4867695 77265.08 IBUPROFEN BP JNPT SEA CHINA 10.00 MT 6089088 9696.02 MANNITOL IP JNPT SEA CHINA 23.00 MT 3282399 2272.45 MANNOGEM EZ MANNITOL IP JNPT SEA USA 6.20 MT 2819073 7240.29 MANNOGEM EZ MANNITOL IP JNPT SEA USA 15.40 MT 7052209 7292.04 MEFENAMIC ACID IP MUMBAI SEA CHINA 12.00 MT 7230792 9564.6 METRPNIDAZOLE BP JNPT SEA CHINA 13.00 MT 8395979 10251.43 METRPNIDAZOLE BP JNPT SEA CHINA 13.00 MT 8575466 10503.98 METRPNIDAZOLE IP JNPT SEA CHINA 13.00 MT 8685495 10605.08 METRPNIDAZOLE IP/BP JNPT SEA CHINA 13.00 MT 8616694 10520.95 NORFLOXACIN IP JNPT SEA CHINA 9.50 MT 15062564 24946.97 OXYTETRACYCLINE HCL IP JNPT SEA CHINA 20.00 MT 19662680 15605.24 OXYTETRACYCLINE HYDROCHILORIDE IP JNPT SEA CHINA 3.00 MT 3132172 16572.38 PARSCETAMOL IP JNPT SEA CHINA 16.00 MT 3785383 3767.38 RIBOFLAVIN ( VITAMIN B2FINE POWDER (IP JNPT SEA KOREA REP 3.00 MT 9353611 49490 ROXITHROMYCIN IP JNPT SEA CHINA 2.00 MT 8372497 66660.03 STREPTOMYCIN SULPHATE STERILE IP JNPT SEA CHINA 5.47 MT 9133632 2658.98 TETRAETHYDROCHLORIDE IP JNPT SEA CHINA 8.00 MT 11017444 21815.92 VESTASOL IP JNPT SEA CHINA 45.60 MT 5646005 1969.43 VESTASOL IP JNPT SEA GERMANY 30.40 MT 3654052 1907.94 VITAMIN B2 FINE POWDER IP JNPT SEA KOREA REP 1.00 MT 3181500 50500 VITAMIN B2 FINE POWDER IP JNPT SEA KOREA REP 1.50 MT 5104965 54192.83 90 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

EXPORT PRICES EXPORT STATISTICS PRODUCTS PORT SOURCE QTY.UNIT VALUE IN RS $/UNIT ACETAZOLAMID-EP HYDERABAD ICD ISTANBUL 1.00 MT 2754529 44427.9 ALBNDAZOLE EP JNPT SEA CHITTAGONG 2.00 MT 3075200 24800 AMLODIPINE BESILATE BP HYDERABAD ICD DURBAN 1.30 MT 12107212 150699.68 AMOXYCILLN TRIHYDRATE BP CHENNAI SEA HO CHI ,INH 2.50 MT 4181146 26975.16 AMOXYCILLN TRIHYDRATE BP JNPT SEA PENANG(GEOR 2.00 MT 3383960 27290 ASPIRIN USP 80 MESH CHENNAI SEA LINCOLN 32.00 MT 9497708 4787.74 BROMHEXINE HCL EP 8 JNPT SEA ROTTERDAM 1.50 MT 2555724 27479.94 ERYTHROMYCIN STEARATE BP JNPT SEA LUSAKA 3.50 MT 6995574 32342.07 ALLOPURINOL EP JNPT SEA EL ISKANDARI 5.00 MT 8474510 27425.57 CARISOPRODOL USP HYDERABAD ICD SANTOS 12.00 MT 18054750 24267.1 CARISOPRODL USP CHENNAI SEA SINGAPORE 3.00 MT 4639770 24945 CIPROFLOXACIN HCL USP JNPT SEA PORT SUDAN 4.00 MT 6340775 25567.58 CIPROFLOXACIN HCL USP JNPT SEA MEXICO CITY 3.00 MT 5134530 27605 CIPROFLOXACIN HCL USP JNPT SEA SANTOS 4.70 MT 8661270 29785.76 CIPROFLOXACIN HCL USP JNPT SEA VERACRUZ 3.00 MT 4880700 26283.39 DEXTROMETHORPHAN HBR/USP CHENNAI SEA BANGKOK 1.00 MT 6280214 101129.19 DEXTROMETHORPHAN HBR/USP CHENNAI SEA SHUWAIKH 1.00 MT 6176449 99620.16 DEXTROMETHORPHAN HBR/USP CHENNAI SEA NAPLES(TALY 1.00 MT 11084210 178777.58 DEXTROMETHORPHAN HBR/USP CHENNAI SEA TORONTO 0.50 MT 199237.86 DILOXANIDEFUROATE B.P AHMEDABAD ICD KARACHI 2.00 MT 2842800 22925.81 DIPHENHYDRAMINE HCL CHENNAI SEA CHICAGO 6.00 MT 7068000 19000 DONEPEZIL HCLUSP JNPT SEA LATAKIA 0.05 MT 3534840 1140270.97 METFORMIN HCL EP JNPT SEA HAMBURG 42.00 MT 1113055 4222.10 ALLOPURINOL EP JNPT SEA ALEXANDRA(EG 2.00 MT 3954856 31894.03 ALLOPURINOL EP JNPT SEA PORT ELIZABE 3.80 MT 7529900 31960.48 ALLOPURINOL EP JNPT SEA XINGANG (CHI 1.34 MT 2613052 31577.67 METFORMIN HCL PH.EUR/USP JNPT SEA ANTWERPEN 19.20 MT 6822720 5750 PHENOBARBITAL EP JNPT SEA BASEL 1.50 MT 2878660 30953.39 ALLOPURINOL USP JNPT SEA CHARLOTTE 9.60 MT 2350646 39621.2 METFORMIN HCL BP/EP JNPT SEA LIMASSOL 10.50 MT 3029738 4654.03 METFORMIN HCL USP JNPT SEA NEW YORK 42.00 MT 1632690 6280.00 RIBOFLAVIN 5 PHOSPHATE SODIUM EP JNPT SEA ROTTERDAM 1.00 MT 4707350 75925 CHLOROQUINE SULPHATE BP JNPT SEA APAPA 1.05 MT 2530710 39000 EFAVIRENZ USP HYDERABAD ICD DURBAN 5.00 MT 3519925 113545.97 ERYTHROMYCIN STERATE BP 99 JNPT SEA MANZANILLO 1.20 MT 3398147 45821.84 ERYTHROMYCIN STERATE BP 99 JNPT SEA MOMBASA 2.50 MT 5270000 34000 ERYTHROMYCIN HCL BP JNPT SEA BRUSSEL (BRU 1.00 MT 275590 44450 ERYTHROMYCIN HCL USP MORADABAD ICD APAPA 360.00 MT 18688320 837.26 FERROUS FUMARATE BP JNPT SEA HAMBURG 23.00 MT 3190734 2244.82 FLUCLOXACILLIN SODIUM BP TUGHLAKABAD ICD EL ISKANDARI 5.00 MT 12045129 38855.32 FLUCLOXACILLIN SODIUM BP TUGHLAKABAD ICD ALEXANDRA(EG 4.75 MT 9887997 33684.14 FLUCONAZOLE USP HYDERABAD ICD BARCELONA 0.60 MT 3323104 89330.81 GLUCOSAMINE HCL HYDERABAD ICD NEW YORK 10.00 MT 5913184 9537.42 GLUCOSAMINE HCL USP CHENNAI SEA NEW YORK 7.00 MT 3741990 8650 GLYCERINE USP JNPT SEA OSAKA 60.00 MT 3069000 825 GUAIFENESIN HYDERABAD ICD NEW YORK 30.00 MT 29452146 15808.87 GUAIFENESIN HYDERABAD ICD NEW YORK 15.00 MT 11057391 11889.68 GUAIFENESIN HYDERABAD ICD TORONTO 5.00 MT 3562732 11529.94 GUAIFENESIN HYDERABAD ICD VERACRUZ 5.00 MT 3292417 10620.65 GUAIFENESIN JNPT SEA TANJUNG PRIO 9.00 MT 5305159 9538.19 GUAIFENESIN BP JNPT SEA JAKARTA 6.00 MT 3336582 8998.38 IBUPROFEN BP JNPT SEA TEMA 4.30 MT 2710485 10050 IBUPROFEN BP CHENNAI SEA TINCAN/LAGOS 9.00 MT 5500429 9857.42 IBUPROFEN BP LUDHIANA ICD TANJUNG PRIO 4.50 MT 2815797 10092.42 IBUPROFEN BP JNPT SEA TEMA 4.00 MT 2719200 11000 IBUPROFEN BP LUDHIANA ICD TINCAN/LAGOS 12.00 MT 7325300 9845.81 IBUPROFEN BP LUDHIANA ICD TINCAN/LAGOS 9.00 MT 5534190 9917.9 IBUPROFEN BP LUDHIANA ICD VALPARAISO 5.00 MT 3107316 10023.55 IBUPROFEN BP CHENNAI SEA BANGKOK 10.00 MT 6023925 9747.41 IBUPROFEN BP CHENNAI SEA EL ISKANDARI 6.00 MT 3923064 10545.81 IBUPROFEN BP CHENNAI SEA LATAKIA 13.00 MT 8077736 10054.37 IBUPROFEN BP LUDHIANA ICD BANDAR ABBAS 8.00 MT 4842920 9795.63 IBUPROFEN BP CHENNAI SEA MIAMI 36.00 MT 24953000 11197.73 IBUPROFEN BP CHENNAI SEA BANDAR ABBAS 10.00 MT 6058000 9770.97 IBUPROFEN BP CHENNAI SEA GUATEMALA CI 18.00 MT 11002376 9858.71 IBUPROFEN BP CHENNAI SEA MANZANILLO 9.00 MT 5648534 10122.74 THE MAZADA PHARMA GUIDE  1May - 15 May 2016 91

EXPORT PRICES EXPORT STATISTICS PRODUCTS PORT SOURCE QTY.UNIT VALUE IN RS $/UNIT IBUPROFEN BP CHENNAI SEA NEW YORK 18.00 MT 12140730 10878.71 KETOCONA ZOLE U.S.P JNPT SEA ROTTERDAM 0.73 MT 2617237 58225..48 KETOCONA ZOLE U.S.P JNPT SEA JAKARTA 3.50 MT 12960140 59916.99 KETOCONA ZOLE U.S.P JNPT SEA SINGAPORE 0.90 MT 3362260 60255.48 KETOCONA ZOLE U.S.P JNPT SEA SINGAPORE 1.00 MT 3699540 59670 KETOCONA ZOLE U.S.P JNPT SEA RALEIGH-DURH 1.00 MT 415274 6549.29 KETOCONA ZOLE U.S.P AHMEDABAD ICD JEDDAH 0.90 MT 3426810 61412.42 L(+CHOLINE BITARTRATE USP JNPT SEA NEW YORK 6.00 MT 3007868 8111.81 LEVETIRACETAM EP CHENNAI SEA ANTWERPEN 5.00 MT 32188846 103835 LEVO MENTHOL BP JNPT SEA HAMBURG 8.00 MT 7628151 15429.13 LEVO MENTHOL BP JNPT SEA ROTTERDAM 8.00 MT 7799996 15725.81 LORATADINE USP JNPT SEA BARCELONA 0.40 MT 4011400 161750 LORATADINE USP JNPT SEA VERACRUZ 0.20 MT 2624955 212375.08 LORATADINE USP JNPT SEA VERACRUZ 0.20 MT 2585465 212365.53 LOSARTAN POTASSIUM USP BANGALORE ICD BALTIMORE 2.06 MT 1642232 129000 LOSARTAN POTASSIUM USP JNPT SEA BUENAVENTURA 1.00 MT 3375900 54450 MAGNESIUM PIDOLATE EP CHENNAI SEA HAMBURG 4.83 MT 2982315 9969.35 MENTHOL BP JNPT SEA GENOA 3.20 MT 2870290 14467.26 MENTHOL USP JNPT SEA SHANGHAI 43.20 MT 35668831 13288.55 METFORMIN HCL JNPT SEA BUSAN(KOREA) 10.00 MT 2776983 4479.03 METFORMIN HCL BP JNPT SEA KOTKA 12.00 MT 3571200 4800 METFORMIN HCL BP JNPT SEA JAKARTA 11.99 MT 3310552 4454.19 METFORMIN HCL BP TUTICORIN SEA BANGKOK 24.00 MT 4425439 2974.03 METFORMIN HCL BP TUTICORIN SEA JEBEL ALI 17.86 MT 3776420 3410.48 METFORMIN HCL BP TUTICORIN SEA BUENOS AIRES 10.00 MT 2915338 4717.31 METFORMIN HCL BP JNPT SEA HAMBURG 22.00 MT 4288850 3144.35 METFORMIN HCL BP JNPT SEA ST PETERSBUR 20.00 MT 5543668 4470.65 METFORMIN HCL USP JNPT SEA SANTOS 20.00 MT 4389600 3540 METFORMIN HCL USP JNPT SEA ROTTERDAM 7.20 MT 3509457 7887.06 METFORMIN HCL USP JNPT SEA ROTTERDAM 7.20 MT 3519884 3281.45 METFORMIN HYDROCHLORIDE BP JNPT SEA BANGKOK 20.00 MT 40690.72 3281.45 METHOCARBAMOL USP HYDERABAD ICD HAMBURG 5.64 MT 6863979 19629.35 METHOCARBAMOL USP HYDERABAD ICD NEW YORK 12.00 MT 13872803 18122.58 METHOCARBAMOL USP JNPT SEA ALEXANDRA(EG 11.50 MT 12539500 17586.94 METRONIDAZOLE BENZOATE EP/BP JNPT SEA ALEXANADRIA 5.01 MT 3599286 11610.65 NABUMETONE EP CHENNAI SEA BUSAN(KOREA) 1.60 MT 7029044 69732.58 NABUMETONE USP CHENNAI SEA PHILADELPHIA 5.00 MT 18924498 61046.77 NAPROXEN BP CHENNAI SEA CHITTAGONG 3.00 MT 5586200 30033.39 NAPROXEN EP CHENNAI SEA LISBOA 7.00 MT 15690664 35990.78 NAPROXEN USP CHENNAI SEA NEW YORK 10.00 MT 21273006 34311.29 NIACIN BP MUNDRA SEA BANGKOK 15.00 MT 4842649 5223.95 NIACIN BP MUNDRA SEA NAVEGANTES 15.00 MT 4820500 5183.39 NIACIN BP MUNDRA SEA COLOMBO 10.00 MT 3220301 5194.03 NIACIN BP MUNDRA SEA SINGAPORE 10.00 MT 3289409 5322.65 NIACIN BP JNPT SEA PARANAGUA 20.00 MT 7328400 5910 NIACIN USP JNPT SEA ALEXANDRA(EG 21.00 MT 7173710 5455.81 NIACIN USP JNPT SEA ALEXANDRA(EG 16.00 MT 5411856 5455.48 NIACIN USP GRANULES JNPT SEA BARCELONA 16.00 MT 5217052 5259.19 NIACIN USP GRANULES JNPT SEA NEW YORK 16.00 MT 4852864 4891.94 NIACIN USP POWDER JNPT SEA GRANDVIEW 18.50 MT 5408242 4730.42 NIACINAMIDE BP HYDERABAD ICD JAKARTA 16.00 MT 6685028 6738.87 NIACINAMIDE USP MUNDRA SEA BUSAN(KOREA) 10.00 MT 4457025 7211.97 NIACINAMIDE USP JNPT SEA CALLAO 10.00 MT 4003030 6456.45 NIACINAMIDE USP MUNDRA SEA KARACHI 10.00 MT 3704128 5974.35 NIACINAMIDE USP MUNDRA SEA JAKARTA 10.00 MT 3933245 6343.87 NICOTINAMIDE BP MUNDRA SEA JAKARTA 10.00 MT 3760096 6064.68 NICOTINAMIDE USP MUNDRA SEA TAJAI 10.00 MT 3955200 6400 NICOTINAMIDEBP JNPT SEA PUSAN 5.50 MT 2920726 8486.94 92 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

MUMBAI CHEMICAL PRICES Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) ORGANIC CHEMICALS Sodium Acetate 50 18 Sodium Alginate (China) 25 185+VAT Acetic Acid Glacial 35 28+EX+VAT Sorbitol 250 46+Ex+VAT Acetone (GI Drums) 160 58+Ex+VAT Stearic Acid (IMP) 50 70+VAT Acryliamide (Liquid) 250 118+Ex+VAT Stearic Acid (Indian) 50 74+Ex+VAT Acrylic Acid 200 67+VAT Styrene Monomer (Resale) 185 80+Ex+VAT Acrlonitrile 69+EX+VAT Tartaric Acid 50 375+Ex+VAT Adipic ACID 25 130+EX+VAT Thiourea 50 115+Ex+VAT Aniline 200 125+EX+VAT Toluene (Per Litre) 200 55+Ex+VAT Benzene (Per Litre) 200 52+Ex+VAT Trichloroethylene 330 60+VAT Benzo Trichloride 200 75+EX+VAT Triethanolamine (Resale 210 92+VAT Benzoate Plasticiser 200 63 Turkey Red Oil (TRO,50%) 200 64+Ex+VAT Benzoyl Chloride 200 110+Ex+VAT Turpentine Oil (mineral) 200 50.40+VAT Benzyl Alcohol (FFC) 200 140+EX+VAT Vinyl Acetate Monomer (VAM) 185 69+EX+VAT Benzyl Chloride 200 80+Ex+VAT Wax Industrial 25 43+VAT Bisphenol-A (russian) 25 118+Ex+VAT Wax Paraffin 24 90+VAT n-Butanol (Barrels) 170 45+Ex+VAT m-Xylene 50+Ex+VAT Butyl Acrylate 180 96+VAT o-Xylene (per Litre) 200 60+Ex+VAT Butyl Carbitol 190 105+Ex+VAT Xylene Mixed (Per Litre) 200 54+Ex+VAT Butyl Stearate 190 90 Camphor (Indian) 25 430 Carbitol 190 85+Ex+VAT INORGANIC CHEMICALS Carbon Tetrachloride 300 90+VAT Cellosolve 195 108+Ex+VAT Ammonium Bicarbonate 50 71+VAT Chloroform 31+Ex+VAT-4 Ammonium Carbonate 50 64+VAT Citric Acid 25 63+VAT Ammonium Chloride 50 16+VAT Cream of Tartar 50 86 Ammonium Nitrate (Melt) 50 34+VAT m-Cresol 190 280+Ex+VAT Ammonium Phosphate 50 96+VAT o-Cresol 200 150+Ex+VAT Ammonium Sulphte 50 21+Ex+VAT p-Cresol 200 270+Ex+VAT Arsenic (White Powder) 38.5 mixed-Cresol 125+EX+VAT Cresylic Acid 25 160 Barium Carbonate 50 30+VAT Cyclohexane 59+Ex+VAT Bleaching Powder 25 18+Ex+VAT Cyclohexanol 190 125+VAT Borax (Granular) 50 32+VAT Cyclohexanone 190 78+Ex+VAT Borax (Powder) 50 32.50+VAT Diacetone Alcohol 170 110+Ex+VAT Boric Acid (Tech.) 25 60+VAT Dibutyl Adipate 200 45 Bromine Liquid 50 425+Ex+VAT Dibutyl Maleate (DBM) 92+EX+VAT Calcium Carbonte 50 28 Dibutyl Phthalate (DBP) 108+Ex+VAT Calcium Carbonte 50 20 Dicyandiamid (DCDA) 25 160+EX+VAT Calcium Chloride 50 16.75 Diethanolamine (DEA) 90+VAT Calcium Chloride 50 9+VAT Diethyl Oxalate 200 55 Calcium Chloride 50 7.5 Diethylene Glycol (DEG) 230 52+Ex+VAT Carbon Disulphide 300 47.5 Diethyl Phthalate (DEP) 200 90+EX+VAT Caustic Potash 65.50+Ex+VAT Dimethyl Formamide 50+Ex+VAT Caustic Soda (Flakes) 50 33+Ex+VAT Dimethyl Phthalate (DMP) 200 102+Ex+VAT Caustic Soda (Lye) Tanker 28+Ex+VAT Dimethylamine (DMA) 200 31.31+Ex+VAT Chromic Acid 50 350+VAT Dimethylamine (DMA) 200 50 Copper Sulphate 50 75+Ex+VAT Dioctyl Adipate 200 135+EX+VAT Diammonium Phosphate 50 78+VAT Dioctyl Maleate (DOM) 126+Ex+VAT Dioctyl Phthalate (DOP) 200 95+Ex+VAT Ferric Chloride (Anhydrous) 50 32 2-EHA 180 156+Ex+VAT Ferric Chloride (Lumps) 50 25 Ethyl Acetate (Resale) 185 55+Ex+VAT Hydro(China) 50 110+Ex+VAT Ethyl Acrylate (Intact) 180 102+VAT Hydrogen Peroxide 50 31.50+Ex+VAT Ethylene Dichloride 200 20+Ex+VAT Hyflosupercell 22.7 58+Ex+VAT EthyleneGlycol (MEG) 230 56+Ex+VAT Litharge 50 110+Ex+VAT Formaldehyde (Resale) 230 16+Ex+VAT Lithopone (China) 25 95+Ex+VAT Formic Acid 25 50+Ex+VAT Magnesium Carbonate (Indian) 50 24 Glycerince (CP) 250 57+Ex+VAT Magnesium Carbonate (Japan) 50 32 Glycerince (IP) 250 64+Ex+VAT Magnesium Chloride (Crystal) 50 7+VAT Glyoxal (Imp) 80+VAT Mercury 34.5 5,855+VAT Glyoxal (Indian) 75+EX+VAT Nitric Acid RCF (60%) Tanker 11+VAT Hexamine 50 73+VAT Phosphoric Acid (Tech) 35&50 70+Ex+VAT n-Hexane (Per Litre) 200 60+Ex+VAT Potassium Bichromate 50 76 Isobutyl Alcohol 170 41+Ex+VAT Potassium Carbonate 50 75+Ex+VAT Isobutyl Alcohol (IPA) 170 70+Ex+VAT Potassium Carbonate (Indian) 50 84+Ex+VAT Maleic Anhydride (MAN) 25 74+Ex+VAT Potassium Permangante 50 325+Ex+VAT Melamine 25 98+Ex+VAT Potassium Phosphate (Di) 50 146+VAT Menthol Bold 1330+Ex+VAT Potassium Phosphate (Mono) 50 118+VAT Menthol Crystal (Flakes) 1300+Ex+VAT Menthol Crystal Bold 1330+Ex+VAT Sada Ash 50 28+Ex+VAT Methanol (Per Litru) (Resale) 200 LIT 19+Ex+VAT Sada Ash (Tata) 50 33+Ex+VAT MMAMonomer 180 kg 97+VAT Sodium Bicarbanate 50 18+VAT Metha Acrylic Acid 180 kg 125+VAT Sodium Bisulphite 50 20 Methyl Acrylate 180 60+VAT Sodium Chloride (Vacuum Salt) 50 15+Ex+VAT Methyl Ethyl Ketone (MEK) 190 58+Ex+VAT Sodium Chloride 80% (India) 50 120 Methylene Dichloride (MDC) 350 45+Ex+VAT Sodium Metasilicate 50 3.7 Monoethanolamine (MEA) 180 92+VAT Sodium Nitrate 50+VAT Nitrobenzene 200 82+Ex+VAT Sodium Nitrate (Resale)(China) 50 60+VAT Octanol (2-ethylhexanol) 170 63+Ex+VAT Sodium Nitrite (RCF) 50 50+VAT Oxalic Acide (Punjob) 50 52+Ex+VAT Sodium Nitrite (RDeepak) 50 34+VAT Paraformaldehyde91% 25 69+EX+VAT Sodium Nitrite (German) 50 40+VAT Pentaerythritol 50 125+EX+VAT Sodium Sulphate (Coarse) 50 12+EX+VAT Peppermint Oil (Rectified) 188+Ex+VAT Sodium Sulphate (Fine) 50 14+Ex+VAT Phenol (GI Drums) 215 92+EX+VAT Sodium Sulphide 50-52%(Flakes) 50 18 Phthalic Anhydride (PAN) 25 66+Ex+VAT Sodium Sulphide 58-60%(Flakes) 50 30 Polyethylene Glycol (PEG 200) 230 135+VAT 3.25+VAT Polyethylene Glycol (PEG 400) 230 130+VAT Sulphuric Acid (70%) Tanker 135+Ex+VAT Titanium Dioxide Anatase (TTP) 25 Polyethylene Glycol (PEG 600) 25 87 Polyvinyl Alcohol (BP 20) 20 125 Titanium Dioxide Anatase (China) 25 130+Ex+VAT Polyvinyl Alcohol (BF 17) 20 130 Titanium Dioxide (Rutile-R-902) 25 150+Ex+VAT Polyvinyl Alcohol (240 G) 20 120 Trisodium Phosphate (IRE) 50 99+VAT Polyvinyl Alcohol (No 170) 20 100 Zinc Acetate 50 90 Polyvinyl Alcohol 20 96+VAT Zinc Chloride Powder (Tech) 50 85+VAT Polyvinyl Alcohol (No 173) 20 128+VAT Zinc Dust 50 142+VAT Propylene Glycol (Indian) 210 80+Ex+VAT Zinc Hydroxide 50 35 Propylene Glycol (Imp) 210 110+Ex+VAT Zinc Oxide (China) 50 140+Ex+VAT Rosin 215 102+VAT Zinc Sulphate (Tech.) 50 28+VAT THE MAZADA PHARMA GUIDE  1May - 15 May 2016 93

MUMBAI DRUGS PRICES Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) ACTIVE PHARMA INGREDIENTS Niachin 50 360 Niacinamide 50 380 Aceclofenac 25 725 Nifedipine 25 1,750 Aerosil 10 515 Nimesulide 25 415 Albendazole 25 1,550 Norfloxacin 25 2,100 Allopurinol 10 1,650 Ornidazole 25 740 Ambroxol HCL 5 2,300 Oxyclozanide B.P (Vet) 25 925 Aminophylline 25 700 Paracetamol 25 193 Amitriptyline HCL 25 2,100 Pentaprazole 5 3,900 Amlodipine Besylate 5 2,800 Pheniramine Maleate 5 925 Amoxycillin Trihydrate 25 1,475 Phenylbutazone 25 680 Amoxycillin Sodium sterile 10 4,700 Phenylephrine HCL 5 7,900 Ampicillin Sodium sterile (Cryst) 10 3,400 Phenytoin Sodium 25 725 AmpicillinTrihydrate 25 1,500 Piperazine Citrate 25 175 Atenolol 25 1,250 Piperazine Hexahydrate 25 170 Azithromycin Dihydrate 5 6,800 Potassium Iodate 25 1,250 Bromhexine HCL 25 1,500 Potassium Iodite 25 1,550 Brompheniramine Maleate 5 5,400 Povidone Iodine 25 550 Cabosil (Fumed Silica) 10 440 Pregabalin 5 5,500 Caffeine 25 700 Propranolol HCL 25 880 Calcium Glycerophosphate 50 390 Pyrazinamide 25 1,100 Carbamazepine 25 2,800 Pyroxicam 25 3,400 Cefatoxime Sodium Sterile 10 7,300 Ranitidine HCL 25 850 Cefixime Trihydrate 5 7,600 Rafoxanide B.P.(Vet) 25 2,800 Cephalexin 25 3,400 Roxithromycin E.P. 5 5,000 Cetrizine Di HCL (EP) 5 2,600 Salbutamol Sulphate 5 4,100 Chloramphenicol 25 5,600 Sildenafil Citrate 5 1,750 Chloramphenicol Palmitate 25 4,100 Simvastatin USP 2 14,500 Chlorbutol 25 440 Sodium Iodide 25 1,650 Chloroquine Phosphate 25 1,250 Tinidazole 50 700 Chlorpheniramine Maleate 5 890 Theophylline Anhydrous 25 690 Chlorzoxazone USP 25 690 Tizainidine HCL 1 19,800 Ciprofloxacin HCL 25 1,600 Tolbutamide 25 650 Clarithromycin 5 11,200 Tramadol HCl 5 975 Clopidogrel bisulphate 10 3,550 Closantel 25 2,800 DRUGS INTERMEDIATES Cloxacillin Sodium 25 1,600 Dexchlorpheniramine Maleate 1 9,200 1-Bromo 3-Chloro Propane 200 270 Diclofenac Potassium 25 510 2-Chloro Pyridine 200 400 Diclofenac Sodium 25 435 Diethyl Malonate 200 185 Dicyclomine HCL 10 1,400 Dimethyl Amino Ethyl Chloride HCL 50 260 Diethyl Carbamazine Citrate 25 640 Dimethyl Carbonate 200 58 Diiodohydroxyquinoline 25 2,400 Dimethyl Formamide 195 60 Diloxanide Furoate 25 1,190 Dimethyl Malonate 200 240 Dinitolmide (D.O.T) 25 310 Dimethyl Sulphoxide 225 98 Diphenhydramine HCL 25 680 Epichlorohydrin 240 87 Enrofloxacin 25 1,900 E.M.M.E. 200 320 Erythromycin Base 25 3,700 Glycine 25 150 Erythromycin Estolate 25 2,650 HMDS (Hexa Methyl Disilazane) 160 390 Erythromycin Stearate 25 2,450 Hydrazine Hydrate 80% 200 250 Ethambutol 50 1,900 Hydroquinone 200 510 Ethamsylate 25 590 Hydrroxylamine HCL 50 185 Ethophylline 25 725 Hydroxylamine Sulphate 25 145 Famotidine 25 2,350 Iodine 50 1,750 FenbendaZole 25 1,750 Isobutyl Benzene 200 110 Fluconazole 5 4,900 Iso Propyl Alcohol 260 78 Fluoxetine HCL 25 2,500 Methane Sulphonyl Chloride 200 175 Frusemide 25 1,850 Methylene Chloride 250 55 Glibenclamide 5 2,050 N-Ethyl Piperazine 180 700 Glipizide 1 9,800 N-Methyl Piperazine 180 470 Guiafenesin 25 480 Morpholine 200 180 Ibuprofen 50 610 N.M.S.M. 50 600 Iron (III)Hydroxide Polymalteose Complex 25 290 Ortho-Nitro Benzaldehydc 50 1,050 Ketoconazole USP 5 3,900 Para Chloro Benzyl Cyanide 225 325 Lamivudine 1 10,500 Piperazine 68% 205 195 Lamotrigene 1 3,400 Piperazine Anhydrous 100 290 Pivaloy Chloride 190 185 Levocetrizine 1 6,400 Lidocaine HCL 25 700 Propionic Anhydrde 180 280 190 230 Pyridine Loratadine 1 9,700 Pyridine Hydrobrobromide 10 1,600 Mebendazole USP 25 1,300 Sodium Metal 150 280 Mefenamic Acid 25 430 TMCS (Trimethyl Chloro Silane) 160 215 Mepyramine Maleate 25 3,250 Triethyl Ortho Formate 180 180 Metformin HCL 25 148 Trimethyl Ortho Formate 180 260 Miconazole Nitrate 25 1,150 94 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

CHENNAI CHEMICAL PRICES Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) ORGANIC CHEMICALS Vinyl Acetate Monomer 185 100 Xylene Mixed 185 74 Acetic Acid (Glacial) 35 48 o-Xylene INORGANIC CHEMICALS 185 80 Acetone 160 65 Benzene 195 Litrs 55 INORGANIC CHEMICALS Benzyl Alcohol 200 175 Bisphenol-A (Russian) 25 155 Acid Slurry (Soft) 50 115 n-Butanol 170 65 Alum -Ferric 50 7 n-Butyl Acetate 165 90 Ammonium Bicarbonate 25 25 Ammonium Bifluoride (Sugar grade) 50 118 Butyl Cellosolve 195 120 Ammonium Carbonate 50 50 Camphor 25 265 Ammonium Chloride 50 24 Carbon Tetrachloride 60 210 Ammonium Nitrate 50 30 Cellosovle (Ethyl) 195 115 Ammonium Phosphate (Mono) 50 80 Chloroform 300 58 Ammonium Su;phate 50 32 Citric Acid (Anhy) 25 80 Antimony Trioxide 50 750 Citric Acid (Mono) 25 65 Barium Chloride 50 55 Cresote Oil 50 60 Bleaching Powder (33%CI) 25 20 Cyclohexanone 190 115 Borax (Granular) 50 48 D D Turpentine 200 Litrs 90 Boric Acid (Tech.) 25 98 Diacetone Alcohol 195 115 Calcium Carbonate (Activated) 50 16 Diethylene Glycol 230 70 Calcium Carbonate 50 17 Dimethyl Formamide 195 90 Calcium Chloride 70% (Solid) 50 12 Dioctyl Phthalate 200 85 Calcium Chloride -Anhydrous 50 22 Di-Pentene 200 Litrs 94 Caustic Potash (Flakes) 50 90 Edta Acid 25 260 Caustic Soda (Flakes) 50 43 Edta Disodium 25 240 Caustic Soda (Prills) 50 58 Edta Tetrasodium 25 228 Chromic Acid (Flakes) 50 245 50 Copper Sulphate 150 Ethyl Acetate 185 77 Diammonium Phosphate 50 32 Ethylene Dichloride 200 50 Dioctymalitr 180 82 Ethylene Glycol - Mono 230 75 Ferric Chlorede (Anhydrous) 50 36 Formaldehyde 65 22 Ferric Chloride (Lumps) 50 34 Formic Acid 35 68 Ferrous Sulphate -Crystals 50 11 Glycerine -CP 250 63 Hydrochloric Acid Naked 6 Hexamine - Tech 50 90 Hydrogen Peroxide 50% 50 34 n-Hexane 160 Litrs 75 Hyflosupercell 22.7 63 Hydroquinone (Imported) 25 800 Litharge 50 198 Isopropyl Alcohol 160 85 Lithopne (China) 25 82 Isopropyl Alcohol (Refill) 160 75 Magnesium Carbonate (Indian) 50 55 Maleic Anhydride 25 100 Magnesium Sulphate 50 14 Methyl Ethyl Ketone 166 100 Mercury 34.5 3,800 Methyl Isobutyl Ketone 160 110 Naphthalene Balls 50 150 Methyl Isobutyl Ketone (Refill) 160 100 Nickel Chloride 25 490 Methylene Dichloride 250 58 Phosphoric Acid (85% Tech) 50 76 Methylene Dichloride (Refill) 250 50 Potassium Carbonate (Powder) 25 110 Mineral Turpentine Oil 50 89 Potassium Carbonate 25 95 72 Monochloro Phenol 50 65 Potassium Nitrate 50 170 50 Potassium Permanganate Nitrobenzene 200 80 Potassium Permanganate 50 200 Octanol (2-Ethyl hexanol) 160 90 Potassium Phosphate (Di) 50 148 Oleic Acid 50 85 Soda Ash Light 50 26 Oxalic Acid (Punjab) 50 55 Sodium Bicarbonate 50 27 Paraffin Wax (White) 50 105 Sodium Bicarbonate 50 132 Paraformaldehyde 91% 25 84 Sodium Bisulphite 50 36 Perchloroethylene 320 65 Sodium Chlorite 50% (India) 50 210 Phenyl Liquid 230 115 Sodium Chlorite 80% (India) 50 225 Phthalic anhydride 25 90 Sodium Cyanide 50 650 Pine Oil 22% 200 Litrs 120 Sodium Fluoride 50 128 Pine Oil 40% 200 Litrs 140 Sodium Formate (Second sales) 50 29 Poly Alumimium Chloride 25 36 Sodium Hexameta Phosphate 50 98 Polyethylene Glycol 400 230 130 Sodium Hydrosulphite (China) 50 118 Polyethylene Glycol 600 230 130 Sodium Metabisulphite 50 38 Propylene Glycol 215 125 Sodium Nitrate 50 52 Red Lead 50 170 Sodium Nitrate (China) 50 55 Renine 180 62 Sodium Silicate Naked 14 Rosin 17 125 Sodium Sulphate (Anhydrous) 50 12 28 Sodium Sulphide 50 Sodium Acetate 50 24 Sodium Sulphide 50 38 Sodium Benzoate 50 120 Sodium Sulphite 92% 50 45 Sorbitol 250 46 Sodium Tripolyphosphate 50 80 Stearic Acid (Cosmetic) 50 90 Titanium Dioxide Anatase 25 140 Styrene Monomer 185 120 Titanium Dioxide (Rutile -R-902) 25 190 Terpeneol Perfumery 25 Litrs 500 Trisodium Phosphate 50 36 Thiourea 25 148 Zinc Chloride Powder (Tech.) 50 60 Toluene (per Litre) 200 Litrs 71 Zinc Oxide 50 160 Trichloroethylene 280 88 Zinc Stearate 25 135 Triethanolamine 210 130 Zinc Sulphate (Tech.) 50 35 THE MAZADA PHARMA GUIDE  1May - 15 May 2016 95

HYDERABAD DRUGS PRICES Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) Name of Chemicals pack (Kgs.) Price Change (Rs./Kg) Aceclofenac 25 850 Omeprazole Sodium 25 2,300 Albendazole 25 1,500 Ofloxacin USP 25 2,600 Alpha Lipoic Acid 25 3,350 Ondansetron HCL Dihydrate 5 6,000 Ambroxol HCL 25 2,400 Oxyclozanide B.P 25 1,150 Amikacin Sulphate 25 10,000 Paracetamol I.P 50 250 Amlodipine Besylate 10 2,450 Phenylephrine HCL 25 10,000 Amitriptyline HCL 25 1,450 Pantoprazole Sodium 25 4,400 Azithromycin Dihydrate 5 6,600 Potassium Iodide 50 2,000 Bronopol B.P 25 560 Propranolol HCL 25 1,400 Cabosil (Fumed Silica) 5 570 Ramipril USP 5 32,000 Carbonyl Iron 25 250 Ranitidine HCL 25 800 Cefexime 25 8,400 Rebeprazole Sodium I.P 25 3,500 Cefuroxime Axetil 25 8,200 Resperidone 25 20,000 Cisplatin 1 2,600/gm Simvastatin 15 14,500 Citrazine I.P 25 2,200 Sildenafil Citrate 25 1,800 Citrazine E.P 25 2,700 Sparfloxacin 5 7,500 Ciprofloxacin HCL 50 1,650 Sertraline HCL 25 4,250 Closantel Base 25 3,200 Sulbactum Sodium 10 6,000 Closantel Sodium Dihydrate 25 4,200 Terbutaline Sulphate IP 25 11,200 Dexamethasone Sodium Phosphate 1 1,10,000 Tramadol HCL 25 1,250 Diclofenac Sodium IP 25 600 TMSI 25 1,900 Domperidone IP 25 3,500 TMP 25 1,650 Drotaverine HCL 25 4,000 Zidovudine 5 14,000 Duloxetine 5 19,000 Zonisamide 5 16,000 Enrofloxacin HCL 25 1,850 Esomeprazole 25 4,200 Escitalopram Oxalate 5 16,800 Famotidine IP/USP 25 2,150 Finasteride 5 1,45,000 Fluconazole 25 5,100 Furazolidone 25 1,800 Gabapentin 25 1,750 Glimepiride EP 5 14,000 Guaifenesin USP 32 25 630 HPMC - E-5, E-15 25 525 Ibuprofen I.P. 25 600 Iodine 50 2,400 Ketoconazole 25 3,650 Ketorolac Tromethamine 5 12,500 Lamotrigene 5 4,600 Levocitrazine 25 6,500 Levoffloxacin 25 2,600 Lineozolid EP 10 13,000 Loperamide 25 9,500 Mannitol B.P 25 250 Metformin HCL 25 175 Montelukast Sodium 1 32,000 Moxifloxacin 10 15,500 Niacinamide I.P 25 500 Niclosamide I.P 25 950 Nimesulide 25 430 Omeprazole pellets 7.5% 25 350 96 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

MEETINGS & CONFERENCES NATIONAL +91:44-42444523 +91:9840276650 :[email protected] May 2016 :Cii.in 12th May Mumbai Workshop on “Safe Handling of Chlorine” September 2016 S.K.Khurana +91-22-25891609 1-3rd September Mumbai +91-9324266543 India Chem 2016 [email protected] Federation of Indian Chambers of Commerce and Industry (FICCI) :Girish Ahuja 12-13th May Mumbai Food Safety India Summit 2016 +91-11-23487315 Global Landmark Media +91-9871883552 Shabaz :[email protected] +91-22-65632232 :Ficci.com/ Indiachem.in +91-8655138554 [email protected] 21-23rd September Goa Globoil India 2016 Tefla’s 13th May New Delhi 5th National Conference on “Potential +91-22-263487315 Of Plasticulture in India” [email protected] Department Of Chemicals & Petrochemicals, “Teflas.com/teflasevents.html Ministry of Chemicals & Fertilizers. 22-24th September Ahmedabad Govt. of India; FICCI Asia Labex 2016- 2 nd International P.S.Singh +91-11-23316540 Exhibition on Analytical,Research, Diagnostic,Laboratory Instruments & +91-9868260724 [email protected] Consumables Fenza Exhibition Pvt. Ltd Pallav Singh June 2016 +91-11-47148781 2-3 June Bengaluru +91-9711182040 5th Edition of Construction Chemicals [email protected] International Conference C3 Asialabex.com Construction Chemicals Manufacturers’ Association 24-25th September Goa Samir Surlaker PORTLORE-2016- An International +91-22-27892856/27880803 Conference & Exhibition on Port, [email protected] Logistics & Resources Tefla’s 17th June Chennai +91-22-26304816/17 International Conference on water [email protected] Management Teflas.com/teflasevents.html Tamil Nadu Technology Development & Promotion Centre, Confederation of Indian Industry. October 2016 Dr.C. Selvaraj 17-18th October New Delhi +044-42444555 (Extn. 562) Tntdpc.com/com/Ciih2otech.com 5th Edition of Indian Conference on Life Cycle Management 2016 [email protected] July 2016 Indialca.com 19th July New Delhi 6th National Conference on Agrochemicals November 2016 Department of Chemical & Petrochemicals 10-11th October Goa & Department of Agriculture, Cooperation & Farmers Welfare, Govt. Of India & FICCI 11th International Crop Science Conference & Exhibition 2016 :P S Singh +91-11-23316540 Pesticides Manufacturers & Formulators Association of India (PMFAI) +91-9868260724 :[email protected] Aparna Deshpande Bhasin +91-22-26734845/46 +91-9821093076 August 2016 [email protected] 26-28th August Chennai Pmfai.org 2nd Edition of Surface & Coating Expo 2016 Confederation Of Indian Industry (CII) :Kalyani Gupta THE MAZADA PHARMA GUIDE  1May - 15 May 2016 97

SPECIAL FEATURE API Sourcing for Regulated Markets - Beginner's Guide The most important thing to know prior to sourcing the The commercial challenges faced while procuring API API is the target market. for regulated markets are: The major requirement in order to use an API for the US Risk in case of single source API suppliers Market is to have a USDMF whereas in case of EU, Aus, Developing Alternate Vendor for regulated markets New Zealand & other regulated markets, it is necessary to incorporates a lot of challenges like: have a Eu-DMF or CEP. Cost for development as well as exhibit batches Technical feasibility However there are many steps we need to validate Prerequisites of the Supplier to be confirmed before before considering the API from the supplier for the US entering the regulated markets. Market: Planning the Stability batches Price Variation filing as it involves a lot of costs USDMF number ( US Actives or USFDA website) Timelines for execution & approvals are long USFDA approved facility ROI on incorporation of alternate vendor GDUFA paid for the site as well as API ( USFDA Their own captive consumption in few cases Website) API triggered in the US Market The technical challenges faced while procuring for the Do they have their own finished formulation? regulated markets are: Do they have any exclusivity? Documentary Support Lead times GDUFA status Campaigning methods LOA for different markets Their 483 records Stability Studies Plant has to be approved by regulatory authorities We need to consider below mentioned steps in order to validate before considering the API from Supplier for EU Backward Integration of API in case of captive & Other Regulated markets: consumptions is necessary: Price Need of the API in terms of complexity CEP or EU-DMF ( EDQM Website) Technical feasibility Plant approved by any EU authority ROI in case of captive consumption of API Registration of Supplier in other Regulated markets Since USA is the target market GDUFA fees incase we intend to start business has to be borne too for the site as Lead times well as DMF. Campaigning methods Consideration of your market share as finished Other Criteria’s to be considered in general: formu lator Vs number of suppliers for that particular API. Documentary Support The feasibility can also be checked with the Regulatory Accreditations help of IMS data. Packaging conditions Global registrations Author : Karan Zaveri Common Monographs Asst. Manager -International Sales at Regulatory compliance & Global support. Swiss Pharma pvt. Ltd. Ahmedabad. 98 THE MAZADA PHARMA GUIDE  1May - 15 May 2016

SPECIAL FEATURE Thirteen Five U-shaped titanium dioxide market will start to turn out the reasonable hirteen Five first year of the enterprises, sulfuric acid rutile tita- by one, the industry is facing first four months of the titani- nium dioxide prices cannot be restructuring, upgrading of the crit- Tum dioxide market ushered maintained bottom ten thousand ical period. Experts pointed out: in in the 'five rising' a rebound, yuan 9500 yuan / ton, the current the harsh market environment, will industry from last year's haze market price war 'vigorous', when force poor allocation of resources, gradually saw the light of the mar- the titanium dioxide business in environmental protection construc- ket. However, this year, although general loss, stick to the end of tion is not in place, unknown rising for five, but the second half 2015 two third-line business is brand, market channel is not of the market will be like? already very difficult. smooth, which do not have the Last September in china, the China’s titanium dioxide indus- competitive advantage of compa- domestic market has experienced try under low excess capacity, the nies naturally choose to give up, this may be determined by the market rather than to people's will turn meaning 'laws of the market.' It was last year's market environ- ment, forcing the titani- um dioxide industry is also part of the produc- tion capacity out of a part of production shut- down, it appeared for the first time since 1998 to 2015 after 17 years of all-industry output declined 4.6% year on year decline. Thirteen Five start overall situation of the economy in china is line with expectations, some bright spots better than expected, expected in the environment favor- able circumstances, a three-day losing streak, the homogenization of serious cases, titanium dioxide industry, ushered 'Golden September' irrepressible in Chinese economy under the in five rising for a rebound, the down market, rutile titanium diox- background of slower growth, suf- domestic real estate market sup- ide prices continue to fall, forcing fered extremely weak market ply and booming, to clear invento- the anatase titanium dioxide pas- demand, only titanium dioxide ry accelerated directly led to the sive fall. Then sulfuric acid rutile, industry price war as a means of paint market, while stimulating the anatase titanium dioxide were competition between business sur- titanium dioxide market, admitted- mainstream offer 10,100 yuan / vival, intense and brutal warlords ly, titanium dioxide industry is the ton and 9,000 yuan / ton. Part degree of competition reached its key to the stock market. rutile type of product has fallen peak, and rapid development from 2016 annual meeting of the below 10,000 yuan / ton mark. the previous hidden dangers National titanium dioxide industry, 'Silver ten' bearish encroaching posed by the outbreak is also one proposed titanium dioxide industry, THE MAZADA PHARMA GUIDE  1May - 15 May 2016 99

SPECIAL FEATURE 'Thirteen Five' plan, plan's goal is and acquisitions, so that the tory quantity and quality and to to promote titanium dioxide indus- industry before the 10 enterprises encourage each other when it has try supply-side structural reforms, concentration of production capac- reached the market equilibrium, titanium dioxide industry in the ity than the 'Twelve Five' the market price more reasonable. future to carry out the 'three to a increased by 20%. Titanium diox- In a market economy, meeting of a down 'capacity to ide industry is the core of the resources tend to focus on high- destocking, de-leveraging, cost reform and innovation, innovative income areas, industrial isomor- reduction, fill short board, disposal solutions is the driving force of the phism trend appears, after some of' zombie companies 'to promote development of titanium dioxide time, it will form overcapacity, to resolve excess capacity. industry, 'innovation' is the titani- excessive competition, excess To promote supply-side struc- um dioxide industry over the years profits disappear. At this time, tural reforms, accelerate the since the short board, short board some resources looking for a new development of new manufactur- up in the new historical period, place, which resulted in innova- ing, fostering the growth of new highlighting its importance in the tion; some relatively slow, but also industries, transform and upgrade new normal, only a really good job remain in place waiting to boil, traditional industries, these key 'fill short board' in order 'to the when looking to 'come full circle elements related to the restructur- production capacity' in order to to my house.' In both cases the ing and development of titanium achieve 'cost reduction' to create differentiation trend formation, is dioxide industry is listed as the a new situation in the sustainable the law dictates. In the new nor- 'Thirteen Five titanium dioxide development of the industry. mal, we need to optimize the allo- industry planning', planning to At present, the titanium dioxide cation of resources, cultivate new encourage the development of pri- industry in the economic operation impetus to the formation of the ority chlorination and advanced of the supply side, structural and new structure, which means that clean production of sulfuric acid institutional problems, will take the sooner the better differentia- process simultaneously route. time, is still in its initial stage, tion. Titanium dioxide industry has Through independent research therefore, five rising Thirteen Five experienced in previous years of and development and the intro- rebound in the first year out of the suffering, there is always a part of duction of cooperation to promote U-shaped market, but in a reason- the differentiation will come to the the development of sets of chlori- able range of marketing activities, fore, while another part of the situ- nation process titanium dioxide from the U in the first half is more ation and choose a separate look production process, etc., so that rational laws of the market into the more profitable compared to 'boil' the proportion of chlorination prod- second half. Reasonable titanium perhaps more way out. ucts of more than 20%. dioxide market in the unfavorable Elimination of backward produc- market demand and overcapacity Author : Khushboo Bhavsar tion capacity, accelerate mergers coexist, and industry to the inven- FP Page : Tiska- Chemicals at Glance 100 THE MAZADA PHARMA GUIDE  1May - 15 May 2016