greenbook4

¬“√—°…“‚√§‡∫“À«“π √“¬™◊ÕË ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡´‡«πà  µ“√å ø“√å¡“´µŸ ‘§Õ≈ 1A 138/42 Glizide Seven Stars Pharmaceutical Co., Ltd. 1A 497/36 Dipazide 1A 114/38 Diasef  ¬“¡‡¿ ™— 1A 678/39 Gipzide Siam Bheasach Co.,Ltd. ¬Ÿπ‘´—π ≈“∫Õ√“∑Õ√’ å Unison Laboratories Co., Ltd. ‡¿ ™— °√√¡»√’ª√– ‘∑∏Ï‘ Sriprasit Dispensary °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 5491

¬“√—°…“‚√§‡∫“À«“π Insulin Injection Õπ‘ ´≈Ÿ ‘π ™π‘¥©’¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªìπ°√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™◊ÈÕ (Sterility Test) - Bacterial Endotoxin (LAL) ººâŸ ≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™ÕË◊ ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ≈≈‘ ≈’Ë ª√–‡∑»Ω√—ßË ‡»  1C 105/42N Humalog Mix Lilly France S.A.S., France 1C 168/44 Humulin 70/30 ≈≈‘ ≈’Ë ø“√å¡“ 1C 387/40 Humulin-N Lilly Pharma Fertigung 1C 388/40 Humulin-R 2C 39/39 Mixtard ‚π‚« πÕ√奠‘ §å ª√–‡∑»‡¥π¡“√§å Novo Nordisk A/S, Denmark 1C 140/39 Insulatard HM ‚Õ≈§‘ (ª√–‡∑»‰∑¬) Olic (Thailand) Ltd. 502 GREEN BOOK 4

¬“√°— …“‚√§‡∫“À«“π Metformin hydrochloride Tablet, 500 mg ‡¡∑øÕ√¡å ‘π ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ºâŸº≈‘µ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Õߧ°å “√‡¿ ™— °√√¡ 1 A 113/45 Metformin hydrochloride Government Pharm. Organization Buformin ∫Ÿ√æ“‚Õ ∂ 1 A 305/41 Metfor Burapha dispensary Co., Ltd. Glucoformin ¡≈‘ ≈‡‘ ¡¥ 1 A 78/45 Millimed Co., Ltd Gluzolyte 𥑠“ ø“√¡å “ 1 A 415/38 Poliformin Nida Pharma Inc., Ltd ø“√¡å “ π— µå ·≈∫Õ√“∑Õ√ ’Ë å 1 A 454/34 Pharmasant Lab. Co., Ltd ‚ª≈ø‘ “√¡å 1 A 60/40 Polipharm Co., Ltd °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 513

¬“≈¥‰¢¡π— „πÀ≈Õ¥‡≈◊Õ¥ - Atorvastatin film coated Tablet - Gemfibrozil Capsule - Gemfibrozil Tablet - Simvastatin film coated Tablet 524 GREEN BOOK 4

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈Õ◊ ¥ Atorvastatin film coated Tablet Õ∑Õ√å«“ ‡µµ‘π ™π¥‘ ‡¡¥Á ‡§≈Õ◊ ∫øî≈¡å À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ૬ (Content uniformity) ººâŸ ≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™◊ÕË ººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‰ø‡´Õ√å ‰Õ√å·≈π¥å ø“√¡å “´Ÿµ§‘ Õ≈ 1 C 117/47(N) Lipitor 20 mg Pfizer Ireland Pharmaceuticals °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 535

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈Õ◊ ¥ Gemfibrozil Capsule 300 mg ‡®¡‰ø‚∫√´‘≈ ™π‘¥·§ª´≈Ÿ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §“à ‡∫Ë’¬ß‡∫π®“°π”È Àπ°— ‡©≈¬Ë’ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºâŸº≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Ë◊ÕºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√å≈π‘ ø“√å¡“´µŸ §‘ Õ≈ Õπ‘ ¥— µ√È’ 1A 622/34 Hidil Berlin Pharmaceutical Industry Ltd. Gozid ‡¬π‡πÕ√å√“≈ ¥√Í°— ‡Œ“ å 1A 196/33 Lipolo General Drugs House Co., Ltd. Polyxit ·¡§‚§√ø“√å 1A 126/38 Macrophar Company Limited ø“√¡å “ π— µå ≈“∫Õ√“∑Õ√ ’ å 1A 334/35 Pharmasant Laboratories Co.,Ltd. 546 GREEN BOOK 4

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈◊Õ¥ √“¬™Õ◊Ë ººŸâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∑’.·¡π ø“√å¡“ 1A 633/33 Delipid T. Man Pharma Limited Partnership Gemfibrozil ¬Ÿπ´‘ —π ≈“∫Õ√“∑Õ√ ’ å 1A 447/41 Unison Laboratories Co.,Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 557

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈◊Õ¥ Gemfibrozil Tablet ‡®¡‰ø‚∫√´‘≈ ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’¬Ë ߇∫π®“°π”È Àπ—°‡©≈¬Ë’ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººŸâ ≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊Ëպ⟺≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√≈å π‘ ø“√¡å “´Ÿµ‘§Õ≈ Õ‘π¥— µ√’È 1A 175/38 Hidil -600 mg Berlin Pharmaceutical Industry Ltd. 1A 381/44 Hidil O.D.- 900 mg ‡ÕÁ¡ ·Õπ¥å ‡Õ™ ·¡π·Ÿ ø§‡®Õ√‘ßË 1A 956/41 Lipozil -600 mg M&H Manufacturing Co.,Ltd. ∑.’ ‚Õ. ø“√¡å “ 1A 168/40 Locholes -600 mg T.O. Pharma Co.,Ltd. 568 GREEN BOOK 4

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈Õ◊ ¥ Simvastatin film coated Tablet ´‘¡«“ µ“µ‘π ™π¥‘ ‡¡¥Á ‡§≈◊Õ∫øî≈å¡ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ÕË◊ ºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√≈å ‘π ø“√å¡“´µŸ ‘§Õ≈ 1A 3/44 Bestatin 10 mg Berlin Pharmaceutical Industry Ltd. 1A 1/45 Bestatin 20 mg 1A 2/45 Bestatin 40 mg ‰∫‚Õ·≈∫ Vascor 10 mg Biolab Co.,Ltd. 1A 5/44 Eucor 10 mg ‡°√Á∑‡µÕ√å ø“√¡å “ 1A 8/43 Greater Pharma Co.,Ltd. 1C 1/43 Simvor 10 mg ·√π·∫Á°´Ë’ ≈“∫Õ√“∑Õ√ ’ å Zimmex 40 mg Ranbaxy Laboratories Co.,Ltd.  ’≈¡ ‡¡¥‘§—≈ 1A 4/44 Silom Medical Co.,Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 579

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ - Antacid Suspension - Bisacodyl enteric coated Tablet - Dicyclomine hydrochloride film coated Tablet - Dicyclomine hydrochloride Syrup - Domperidone oral Suspension - Domperidone Tablet - Hyoscine butylbromide coated Tablet - Loperamide hydrochloride Capsule - Metoclopramide hydrochloride Injection - Metoclopramide hydrochloride Tablet - Omeprazole Capsule - Omeprazole sodium sterile Powder - Ranitidine hydrochloride Tablet - Sulfasalazine Tablet 5680 GREEN BOOK 4

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Antacid Suspension ¬“≈¥°√¥ ™π‘¥π”È ·¢«πµ–°Õπ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - §«“¡ “¡“√∂„π°“√≈¥°√¥ (Acid - Neutralizing Capacity) - ª√‘¡“≥‡™ÕÈ◊ ®≈ÿ π‘ ∑√’¬å (Microbial Limit) ºâºŸ ≈µ‘ ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™Ë◊ÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‰∑¬π§√æ—≤π“ 2A 356/2529 Antacil Gel Thai Nakorn Pattana Co., Ltd. 2A 171/2529 Belcid ‰∫‚Õ·≈∫ Biolab Co., Ltd °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 6591

¬“√°— …“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Bisacodyl enteric coated Tablet ∫‘ ´“‚§¥≈‘ ™π‘¥‡¡¥Á ‡§≈Õ◊ ∫‡Õπ‡∑Õ√°‘ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - °“√·µ°°√–®“¬µ«— ¢Õ߇¡¥Á ¬“ ·≈–ª√‘¡“≥µ—«¬“∑Ë≈’ –≈“¬ (Disintegration as delayed-release for enteric coated) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) ºâŸº≈µ‘ ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ËÕººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡¡¥´‘ π’ ‚ª√¥—° å 1A 1104/29 Bisacod Medicine Products Co., Ltd. (enteric sugar coated) 𑫉≈øá ø“√å¡“ 1A 490/41 Bisacodyl New Life Pharma. Co., Ltd. (enteric sugar coated) ‚Õ≈§‘ (ª√–‡∑»‰∑¬) 1A 1044/41 Laxitab Olic (Thailand) Ltd. (enteric coated) 602 GREEN BOOK 4

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ø“√å¡“ π— µå ·≈∫Á ∫Õ√“µÕ√Ë ’ å 1A 63/36 Laxcodyl Pharmasant Laboratories Co., Ltd. (enteric coated) Õß— °ƒ…µ√“ߟ (·Õ≈.æ’) 1A 1005/28 Emulax The British Dispensary (L.P.) Co.,Ltd. (enteric coated) ‡¿ ™— °√√¡‡§.∫.’ ®”°—¥ 1A351/46 K.B.Biscod K.B.Pharmaceutical Co., Ltd. (enteric sugar coated) °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 613

¬“√—°…“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Dicyclomine hydrochloride film coated Tablet ‰¥‰´‚§≈¡π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥‡§≈Õ◊ ∫ø≈î å¡ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content uniformity) ºâºŸ ≈‘µ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™ÕË◊ ººŸâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√≈å π‘ ø“√å¡“´µŸ ‘§Õ≈ Õ‘π¥ — µ√È’ 1A 65/32 Dicomin Berlin Pharmaceutical Industry Co., Ltd. 624 GREEN BOOK 4

¬“√—°…“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Dicyclomine hydrochloride Syrup ‰¥‰´‚§≈¡’π ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥π”È ‡™Õ◊Ë ¡ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) ºâºŸ ≈‘µ∑’ºË à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚ª≈ø‘ “√¡å 2A 255/30 Berclomine Polipharm Co., Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 635

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Domperidone oral Suspension, 1mg/ml ¥Õ¡‡æÕ√‘‚¥π ™π‘¥πÈ”·¢«πµ–°Õπ ”À√∫— √∫— ª√–∑“π À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªìπ°√¥-‡∫  (pH) ºŸºâ ≈‘µ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™◊ËÕºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ≈ ∫’ ‡Õ  ≈“∫Õ√“∑Õ√ ’ å 1A 587/31 Doperan L.B.S. Laboratory Ltd., Part 1A 752/38 Domperdone ‚æ≈ø‘ “√å¡ Polipharm Co., Ltd. 1A 554/39 Pondperdone æÕπ¥å ‡§¡‘§Õ≈ å 1A 837/32 Dany Pondûs Chemicals (Thailand)  ¬“¡ ‡¡¥‘·§√å Siam Medicare Co., Ltd. 646 GREEN BOOK 4

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ √“¬™◊ÕË ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∑’ ·¡π ø“√¡å “ 1A 863/30 Dominox T.Man Pharma Ltd., Part 1A 901/43 Motidom ∑’ ‚Õ ø“√å¡“ T.O. Pharma Co., Ltd. 1A 143/41 Rabugen ¬Ÿπ´‘ —π ≈“∫Õ√“∑Õ√ Ë’ å Unison Laboratories Co., Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 657

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Domperidone Tablet, 10 mg ¥Õ¡‡æÕ√‘‚¥π ™π¥‘ ‡¡¥Á À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §“à ‡∫’ˬ߇∫π®“°πÈ”Àπ°— ‡©≈Ë’¬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ºŸâº≈µ‘ ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™Ë◊ÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∫“ß°Õ° ·≈∫ ·Õπ¥å §Õ ‡¡µ‘§ 1A 245/40 Domper-M Bangkok Lab & Cosmetic Co., Ltd. Mirax-M ‡∫Õ√å≈π‘ ø“√å¡“´µŸ ‘§Õ≈ Õπ‘ ¥ — ∑√’Ë 1A 752/44 Mirax Berlin Pharmaceutical Industry. 1A 292/32 Ltd., Part Mocydone-M ø“√¡å “ π— µå ≈“∫Õ√“∑Õ√Ë’ å 1A 262/41 Pharmasant Laboratories Co., Ltd. 668 GREEN BOOK 4

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ √“¬™Õ◊Ë ººŸâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name 𥑠“â ø“√¡å “ 1A 326/45 Stil ium Nida Pharma Inc.Co., Ltd. 1A 252/43 Domp-M ™ÿ¡™π‡¿ —™°√√¡ Community Pharmacy Public 1A 86/40 Moridon Co., Ltd. 1A 1213/41 Moridon-M 1A 58/35 Molax-M 𑫉≈øá ø“√å¡“ 1A 2501/29 1A 2252/29 Molax New Life Pharma Co., Ltd. Dominox 1A 460/38  ¬“¡‡¿ —™ 1A 350/30 Motidom-M Siam Bheasach Co., Ltd. 1A 2028/30 Motidom Dolium ∑’·¡π ø“√å¡“ T. Man Pharma Ltd.,Part ∑’‚Õ ‡§¡§‘ —≈ å T. O. Chemicals (1979) Ltd. ¬Ÿ‚∑‡ªôï¬π Utopian Co., Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 679

¬“√°— …“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Hyoscine butylbromide coated Tablet, 10 mg Œ—¬ÕÕ ´π’ ∫‘«∑≈‘ ‚∫√¡“¬¥å ™π‘¥‡¡¥Á ‡§≈Õ◊ ∫ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫’¬Ë ߇∫π®“°π”È Àπ°— ‡©≈’¬Ë (Weight variation)  ”À√∫— film coated - °“√·µ°°√–®“¬µ«— ¢Õ߇¡Á¥¬“ (Disintegration) - °“√µ√«® Õ∫ Related substances ºâŸº≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™Ë◊ÕºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ∫“ß°Õ° ·≈∫ ·Õπ¥å §Õ ‡¡µ§‘ 1 A101/38 Spascopan Bangkok Lab & Cosmetic Co., Ltd. Myspa ‡°√Á∑‡µÕ√å ø“√¡å “ 1 A355/44 Greater Pharma Co., Ltd. Butyl ¡“´“·≈∫ 1 A942/40 U-oscine Masa Lab Co., Ltd Higan ¬Ÿ‡¡¥â“ 1 A 641/44 Umeda Co., Ltd ¬πŸ ´‘ —π ≈“∫Õ√“∑Õ√ ’Ë å 1 A 525/42 Unison Lab. Co., Ltd 6780 GREEN BOOK 4

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Loperamide hydrochloride Capsule ‚≈‡æÕ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ·§ª´≈Ÿ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–Àπ૬ (Content uniformity) ºâŸº≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™ÕË◊ ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name 𑫉≈øá ø“√å¡“ 1A 187/39 Dainox New Life Pharma Co., Ltd. Impelium ∑’.‚Õ.‡§¡’§Õ≈ å (1979) 1A 625/31 Loperamide T.O. Chemicals (1979) Co., Ltd. Õߧ尓√‡¿ ™— °√√¡ 1A 318/43 Government Pharm. Organization °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 7691

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Metoclopramide hydrochloride Injection ‡¡∑‚∑‚§≈æ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ©¥’ À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™◊ÈÕ (Sterility Test) - Bacterial Endotoxin (LAL) ºâŸº≈‘µ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ≈.∫’.‡Õ . ·≈∫∫Õ√“∑Õ√ ’ å 1A 1078/30 H-peran L.B.S. Laboratory Ltd., Part Vomitin 𑥓â ø“√¡å “ Õπ‘ §Õ√åªÕ‡√™—Ëπ 1A 6/29 Nida Pharma Incorporation Metoclopramide Co., Ltd. Õߧ°å “√‡¿ ™— °√√¡ 1A 458/48 Government Pharm. Organization 702 GREEN BOOK 4

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Metoclopramide hydrochloride Tablet ‡¡∑‚∑‚§≈æ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°π”È Àπ—°‡©≈’¬Ë (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºŸâº≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ËÕºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 900/27 Maril Atlantic Laboratories Corp. Ltd. R-J ‡¡¥´‘ ’𠂪√¥°—  å 1A 1969/29 Nausil Medicine Products Co., Ltd. Nausin  ¬“¡‡¿ —™ 1A 647/29 Siam Bheasach Co., Ltd. Metoclor ∑.’ ·¡π ø“√¡å “ 1A 927/27 T.Man Pharma Ltd. Part.  À·æ∑¬‡å ¿ —™ 1A 504/27 The Medic Pharma Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 713

¬“√—°…“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Omeprazole Capsule, 20 mg ‚Õ‡¡æ√“‚´≈ ™π‘¥·§ª´Ÿ≈ À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫Ë’¬ß‡∫π®“°π”È Àπ°— ‡©≈¬Ë’ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ºâºŸ ≈µ‘ ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Õ◊Ë ºŸâº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 1A 312/35 Zefxon Biolab Co.,Ltd. 1A 485/36 Miracid ‡∫Õ√å≈π‘ ø“√¡å “´µŸ ‘§Õ≈ Õπ‘ ¥— ∑√’Ë Berlin Pharmaceutical Industry. 1A 327/44 Omepac Ltd., Part Õ‘π·æ§ø“√å¡“ Inpac Pharma 724 GREEN BOOK 4

¬“√°— …“‚√§√–∫∫∑“߇¥‘πÕ“À“√ √“¬™◊ËÕºŸâº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚æ≈ø‘ “√¡å 1A 230/39 Opramed Polipharm Co.,Ltd. 1A 21/41 O-Sid  ¬“¡‡¿ —™ Siam Bheasach Co.,Ltd. 1A 343/35 Desec ∑’.‚Õ. ‡§¡‘§≈—  å T.O. Chemicals ( 1979) Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 735

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Omeprazole sodium sterile Powder ‚Õ‡¡æ√“‚´≈ ‚´‡¥’ˬ¡ ™π‘¥ºßª√“»®“°‡™◊ÈÕ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™È◊Õ (Sterility Test) - °“√µ√«® Õ∫ “√°Õà ‰¢â (Bacterial Endotoxin Test, LAL) -  “√ ≈“¬µ«— (Degradation product) ºŸâº≈µ‘ ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™ËÕ◊ ºâŸº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Astra Zeneca, Sweden 1B 20/43 Losec (º·Ÿâ ∑π®”Àπ“à ¬ : ‚Õ≈§‘ (ª√–‡∑»‰∑¬)) Zefxon ‰∫‚Õ·≈∫ 1A 32/47 Omesec Biolab Co.,Ltd. Omez Natco, India 1C 181/47 (º·âŸ ∑π®”Àπà“¬ :  À·æ∑¬å‡¿ ™— ) Dr. Reddyûs Laboratories, India 1C 6/48 (ºâŸ·∑π®”Àπ“à ¬ : π’‚Õø“√¡å ) 746 GREEN BOOK 4

¬“√—°…“‚√§√–∫∫∑“߇¥‘πÕ“À“√ Ranitidine hydrochloride Tablet, 150 mg √“π∑‘ ¥‘ π’ ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥‡¡Á¥ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §“à ‡∫ˬ’ ߇∫π®“°π”È Àπ°— ‡©≈Ë’¬ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - °“√µ√«® Chromatographic Purity ºŸâº≈µ‘ ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Ë◊պ⺟ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√å≈π‘ ø“√å¡“´µŸ ‘§Õ≈ Õ‘π¥— ∑√’Ë 1A 67/33 Xanidine Berlin Pharmaceutical Industry Ltd. Ranidine ‰∫‚Õ·≈∫ 1A 24/27 Biolab Co., Ltd. Utac ¡≈‘ ≈‡‘ ¡¥ 1A 426/46 Millimed Co., Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 757

¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√ Sulfasalazine Tablet ´≈— ø“´“≈“´’π ™π¥‘ ‡¡Á¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫Ë’¬ß‡∫π®“°π”È Àπ°— ‡©≈¬’Ë (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) ºâºŸ ≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™ÕË◊ ºâŸº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 1165/27 Saridine Atlantic Laboratories Corp. Ltd. Salazopyrin EN ø“√¡å “‡´’¬ ª√–‡∑» «‡’ ¥π 1C 192/39 Pharmacia AB, Sweden 768 GREEN BOOK 4

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® - Acetylcysteine (N-acetylcysteine) sterile Solution - Aminophylline Tablet - Beclometasone dipropionate Inhaler - Hydroxyzine hydrochloride Tablet - Salbutamol Inhaler - Triprolidine hydrochloride and Pseudoephedrine hydrochloride Tablet - Terbutaline sulfate Injection - Terbutaline sulfate Tablet °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 779

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Acetylcysteine (N-acetylcysteine) sterile Solution Õ‡´∑≈‘ ´’ ∑’π ™π¥‘  “√≈–≈“¬ª√“»®“°‡™◊ÈÕ À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) ººâŸ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™◊ÕË ºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ·Õ≈.∫.’ ‡Õ .≈“∫Õ√“∑Õ√ ’ å 1A 1088/44 Acetin L.B.S. Laboratories Ltd. Part. 1C220/27 Fluimucil ·´¡∫Õπ °√äÿª, ª√–‡∑»Õ‘µ“≈’ Zambon Group, Italy 7880 GREEN BOOK 4

¬“√°— …“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Aminophylline Tablet, 100 mg Õ¡‘‚πøî≈≈’π ™π‘¥‡¡Á¥ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºŸºâ ≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ·Õµ·≈𵑰 ≈“∫Õ√“∑Õ√ ’ å 1A 1091/28 Aminophyl ine Atlantic Laboratories Corp., Ltd. Aminophyl ine ¬Ÿ‡πˬ’ π ¥√°—  å ≈“∫Õ√“∑Õ√’ å 1A 520/33 Fileen Union Drug Laboratories Ltd. Aminophyl ine ∫√‘…∑— ‡¿ ™— °√√¡»√’ª√– ∑‘ ∏‘Ï ®”°—¥ 1A 235/36 Sriprasit Pharmaceutical Ltd. À“â ßÀπâÿ  «à π®”°¥— ‡Õ.‡ÕπÁ .‡Õ™. ‚ª√¥§—  å 1A 560/28 A.N.H. Products °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 8791

¬“√—°…“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Beclometasone dipropionate Inhaler ‡∫‚§≈‡¡∑“‚´π ‰¥‚æ√‰æ‚Õ‡π∑ ™π¥‘  Ÿ¥æπà À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) ºâºŸ ≈‘µ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Chiesi Farmaceutici S.P.A., Italy 1C 42/40 Clenil 50 mcg (º·Ÿâ ∑π®”Àπ“à ¬: ·ª´‘ø§î ‡Œ≈∏å·§√å 1C168/41 Clenil 250 mcg ª√–‡∑»‰∑¬) 802 GREEN BOOK 4

¬“√°— …“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Hydroxyzine hydrochloride Tablet ‰Œ¥√ÁÕ°´‘´’π ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥‡¡Á¥ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑’ºË à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ËÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ∫“ß°Õ°·≈∫ ·Õπ¥å §Õ ‡¡µ‘° 1A 389/37 Alerax - FC Tablet Bangkok Lab & Cosmetic Co.,Ltd. 10 mg. ∫√Ÿ æ“‚Õ ∂ 1A 571/40 Dormirax Tablet Burapha Osoth Co.,Ltd. 10 mg.  À·æ∑¬å‡¿ ™— 1A 601/40 The Medic Pharma Hydroxzine-FC Tablet 10 mg. ø“√¡å “ —πµå ≈“∫Õ√“∑Õ√’ å 1A 64/36 Cerax Tablet 10 mg. Pharmasant Laboratories Co.,Ltd. 1A 2102/30 Antizine Tablet 10 mg.  ¬“¡‡¿ ™— 1A 2027/29 Histan Tablet 10 mg. Siam Bheasach Co.,Ltd. ∑’.‚Õ. ø“√¡å “ 1A 909/41 Taraxin Tablet 10 mg. T.O. Pharma Co.,Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 813

¬“√°— …“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Salbutamol Inhaler ´≈— ∫Ÿ∑“¡Õ≈ ™π‘¥ ¥Ÿ æàπ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - °“√µ√«® Õ∫ Related substances ººâŸ ≈µ‘ ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™◊ËÕººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Chiesi Farmaceutici S.P.A., Italy 1 B 2/45 Butovent (ºŸ·â ∑π®”Àπà“¬: ‚Õ≈§‘ ª√–‡∑»‰∑¬) Laboratorio Aldo-Union SA., Spain 1C 217/43 Buto-asma Inhaler (ºŸâ·∑π®”Àπà“¬: ‡°√∑Á ‡µÕ√øå “√å¡“) 824 GREEN BOOK 4

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Triprolidine hydrochloride and Pseudoephedrine hydrochloride Tablet ‰µ√‚æ√≈¥‘ π’ ‰Œ‚¥√§≈Õ‰√¥å ·≈– ´‚Ÿ ¥Õø’ ¥ï √π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ºŸâº≈µ‘ ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ÕË◊ ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ∑’ ‚Õ ‡§¡§‘ ≈—  å 2A 133/36 Sufed T.O. Chemical(1979) Co., Ltd. 2A 23/33 Nasolin ‰∑¬π§√æ—≤π“ Thai Nakorn Patana Co.,Ltd. 2A 655/28 Policold ‚æ≈‘ø“√¡å 2A 90/40 Nasifed Polipharm Co., Ltd. 2A 173/41 Colidine ∫√Ÿ æ“‚Õ ∂ Burapha Dispensary Co.,Ltd. ∑’ ·¡π ø“√å¡“ T. Man Pharma Co., Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 835

¬“√—°…“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Terbutaline sulfate Tablet, 2.5 mg ‡∑Õ√å∫∑Ÿ “≈π’ ´—≈‡øµ ™π‘¥‡¡¥Á À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à ‡∫’¬Ë ߇∫π®“°π”È Àπ—°‡©≈¬’Ë (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑’ºË à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™◊ËÕºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∫“ß°Õ° ·≈∫ ·Õπ¥å §Õ ‡¡µ‘° 1A 54/38 Framagon Bangkok Lab & Cosmetic Co., Bucanyl ∫Ÿ√æ“‚Õ ∂ 1A 72/41 Turbuline Burapha Dispensary Co., Ltd. Bronconyl ‡®√‘≠‡¿ —™·≈∫ 1A 1462/28 Charoen Bhaesaj Lab Co., Ltd. π«‘ ‰≈øá ø“√å¡“ 1A 32/39 New Life Pharma Co., Ltd. 846 GREEN BOOK 4

¬“√°— …“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® √“¬™◊ËÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ø“√¡å “ π— µå ≈“∫Õ√“∑Õ√ ’Ë å 1A 2254/29 Bronchonyl Pharmasant Lab. Co., Ltd. Terbutaline ∑’ ‚Õ ‡§¡‘§≈—  å 1A 417/29 Bucaril T.O. Chemicals (1979) Co., Ltd. ¬Ÿ‚∑‡ªï¬π 1A 1158/28 Utopian Co., Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 857

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Terbutaline sulfate Injection, 0.5 mg/ml ‡∑Õ√∫å ∑Ÿ “≈’π´—≈‡øµ ™π‘¥©’¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) ºâºŸ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊ÕË ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Õߧ尓√‡¿ —™°√√¡ - Terbutal Government Pharm. Organization Baltic ·Õ≈.∫.’ ‡Õ .≈“∫Õ√“∑Õ√’ å 1A 395/30 L.B.S. Laboratories Ltd. Part. 868 GREEN BOOK 4

‚§√ß°“√ √â“ßÀ≈°— ª√–°—π§ÿ≥¿“æ ·≈–¡“µ√∞“π∫√‘°“√¥“â 𬓠ªßï ∫ª√–¡“≥ 2550 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 89

¬“ªØ‘™’«π– - Ampicillin for Injection - Cefazolin for Injection - Erythromycin for oral Suspension - Erythromycin stearate Tablet - Neomycin sulfate Tablet - Penicillin G sodium for injectable Suspension - Streptomycin sulfate for Injection - Sulbactam and Cefoperazone for Injection 8980 GREEN BOOK 4

¬“ªØ‘™«’ π– Ampicillin for Injection ·Õ¡æ‘´‘≈𑠙𥑠©’¥ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ૬ (Content uniformity) - ª√‘¡“≥π”È (Water content) ºŸâº≈‘µ∑Ë’º“à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™ËÕ◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ ™— °√√¡ ·Õµ·≈𵑰 1A 1822/28 Ampilin 1 g Atlantic Laboratories Corp. Ltd Ampicillin Õߧ尓√‡¿ —™°√√¡ 1A 219/49 Ampra Government Pharm. Organization Ampin ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√ßË‘ 1A 26/36 M&H Manufacturing Co.,Ltd. Nadicillin ‚¡‡¥Õ√πå ·¡πŸ 1A 202/29 Modern Manu. Ltd. 𑥓â ø“√å¡“ Õπ‘ §Õ√åªÕ‡√™Ëπ— 1A 1126/27 Nida Pharma Incorporation Co.,Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 9891

¬“ªØ™‘ ’«π– Cefazolin for Injection ‡´øø“‚´≈𑠙𥑠©’¥ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–Àπ«à ¬ (Content uniformity) ºŸºâ ≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ≈ ∫’ ‡Õ  ≈“∫Õ√“∑Õ√’ å 1A 589/31 Cefaben L.B.S. Laboratory Ltd., Part Cefazol ‡¬π‡πÕ√√å “≈ ¥√—Í°‡Œ“ å 1A 990/27 Zefa M.H. General Drugs House Co., Ltd. Zolicef ‡ÕÁ¡ ·Õπ¥å ‡Õ™ ·¡π·Ÿ ø§‡®Õ√‘ßË 1A 1799/30 M&H Manufacturing Co.,Ltd. ¡≈‘ ≈‡‘ ¡¥ 1A 391/47 Millimed Co., Ltd 902 GREEN BOOK 4

¬“ªØ™‘ «’ π– √“¬™Ë◊ÕººŸâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚¡‡¥Õ√πå ·¡πŸ 1A 145/42 Zofalin Modern Manu. Ltd. Cefazol π¥‘ â“ ø“√¡å “ Õ‘π§Õ√ªå Õ‡√™Ë—π 1A 1291/27 Nida Pharma Incorporation Co., Ltd Fazolin  ¬“¡‡¿ —™ 1A 1807/30 Siam Bheasach Co.,Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 913

¬“ªØ‘™«’ π– Erythromycin for oral Suspension Õ√’ ‘∑‚∏¡¬— ´‘π ™π‘¥πÈ”·¢«πµ–°Õπ ”À√∫— √∫— ª√–∑“π À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) ºŸºâ ≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™ÕË◊ ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡Õ‡´¬’ π ø“√¡å “´Ÿµ§‘ Õ≈ 1A 1150/29 Erythromycin Asian Pharm. Ltd. Part. Tomcin ‡¬π‡πÕ√√å “≈ ¥√—°Í ‡Œ“ å 1A 253/28 Newthrocin General Drugs House Co., Ltd. Erythro 𑫉≈øá ø“√¡å “ 1A 449/40 New Life Pharma Co., Ltd. ‚Õ ∂ Õ‘π‡µÕ√å·≈∫ 1A 405/31 Osoth Inter Lab. Co.,Ltd. 924 GREEN BOOK 4

¬“ªØ™‘ «’ π– √“¬™ÕË◊ ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 765/31 Erolex Pondûs Chemical (Thailand) R.O.P. Erimycin Rintacin  ¬“¡‡¿ —™ 1A 1123/28 Erycon Siam Bheasach Co., Ltd Erimit ∑.’ ·¡π. ø“√å¡“´µŸ ‘§Õ≈ 1A 1171/28 Medthrocin T.MAN Pharma Ltd.,Part. Eryo ∑.’ ‚Õ. ø“√¡å “ 1A 462/38 T.MAN Pharma Ltd.,Part. ∑’.æ.’ ¥√°— ≈“∫Õ√“∑Õ√’ å (1969) 1A 347/38 T.P.Drug Laboratories (1969) Co.,Ltd. ¬Ÿ‚∑‡ª¬ïô π 1A 647/27 Utopian Co., Ltd. ‡« ‚° ø“√å¡“´µŸ ‘§Õ≈ 1A 25/40 Vesco Pharm.,Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 935

¬“ªØ™‘ ’«π– Erythromycin stearate Tablet Õ’√∑‘ ‚∏¡¬— ´‘π  ‡µ√¬’ ‡√∑ ™π¥‘ ‡¡¥Á À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™◊ËÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∑’.·¡π ø“√¡å “ 1A 299/33 Ritacin T.Man Pharma Ltd. Part. ∑.’ ‚Õ. ‡§¡§‘ ≈—  å 1A1207/31 Erycon T.O. Chemicals (1979) Co., Ltd. ·¡§‚§√ø“√å 1A 2163/29 Stacin Macrophar ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√ß‘Ë 1A 743/32 Malocin M&H Manufacturing Co.,Ltd. æÕπ¥å ‡§¡§’ Õ≈ (ª√–‡∑»‰∑¬) 1A 86/33 Erytromycin stearate Pondûs Chemical (Thailand) R.O.P. 946 GREEN BOOK 4

¬“ªØ‘™«’ π– Neomycin sulfate Tablet π’‚Õ¡¬— ´‘π ´—≈‡øµ ™π‘¥‡¡¥Á À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - §“à ‡∫’ˬ߇∫π®“°π”È Àπ—°‡©≈¬Ë’ (Weight variation) - °“√·µ°°√–®“¬µ—«¢Õ߇¡¥Á ¬“ (Disintegration) ºâºŸ ≈‘µ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™◊Ëպ⟺≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡°√∑Á ‡µÕ√å ø“√å¡“ 1A1840/29 Myneocin Greater Pharma Ltd. Part 2A122/43 Basina ∑’.·¡π ø“√å¡“ T.Man Pharma Ltd. Part. 1A1111/30 Neobemed ‰∑¬ø“√凡¥ 1942 Thaipharmed 1942 Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 957

¬“ªØ‘™’«π– Penicillin G sodium for injectable Suspension ‡æπ‘´≈‘ ‘π ®’ ‚´‡¥’¬¡ ™π‘¥¬“πÈ”·¢«πµ–°Õπ ”À√—∫©’¥ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈¬Ë’ (Weight variation) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - °“√µ√«® Õ∫ “√°àÕ‰¢â (Bacterial Endotoxin Test, LAL) - °“√∑¥ Õ∫ Particulate Matter ººâŸ ≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™◊ËÕººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡¬π‡πÕ√å√“≈ ¥√°Í— ‡Œ“ å 1A 1124/30 Penicilin G Sodium General Drugs House Co., Ltd. ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡π·Ÿ ø§‡®Õ√‘ßË 1A 1474/29 Penicilin G Sodium M&H Manufacturing Co.,Ltd. ‚Õ≈π— -‡§¡‡¡¥ 1A 669/32 Sodium Penicilin G Olan-Kemed ‚¡‡¥Õ√πå ·¡πŸ 1A 765/29 Sodipen Modern Manu. Ltd. 968 GREEN BOOK 4

¬“ªØ™‘ «’ π– Streptomycin sulfate for Injection  ‡µ√ª‚µ¡“¬´‘π ´≈— ‡øµ ™π¥‘ ©’¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫¬Ë’ ߇∫π®“°π”È Àπ—°‡©≈’¬Ë (Weight variation) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - °“√µ√«® Õ∫ “√°àÕ‰¢â (Bacterial Endotoxin Test, LAL) ºŸºâ ≈‘µ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™Ë◊պ⺟ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡¬π‡πÕ√å√“≈ ¥√—°Í ‡Œ“ å 1A 1601/29 Strepto General Drugs House Co., Ltd. ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡π·Ÿ ø§‡®Õ√Ëß‘ 1A 888/28 Streptomycin sulfate M&H Manufacturing Co.,Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 979

¬“ªØ‘™’«π– Sulbactam and Cefoperazone for Injection ´≈— ·∫§·∑¡ ·≈– ‡´ø‚ø‡æÕ√“‚´π ™π¥‘ ©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - °“√∑¥ Õ∫ Particulate Matter - µ√«®ª√‘¡“≥πÈ” (Water content) ºâºŸ ≈‘µ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ÕË◊ ºâŸº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name  ¬“¡‡¿ ™— 2A1/45(NG) Sulcef Siam Bheasach Co., Ltd 19080 GREEN BOOK 4