how generic medicines are made

HOW GENERIC MEDICINES ARE MADE TIPS FOR YOUR HEALTH CARE Altabrisa Group Limited, LLC

CONTENT Generic medicines are made through a process known as generic drug manufacturing. The process involves several steps to ensure that the generic version of a medication is equivalent to its brand- name counterpart in terms of safety, quality, dosage form, strength, route of administration, and intended use. Here is a general overview of how generic medicines are made 1 2 3 4 Active Research and Obtaining Pharmaceutical Formulation Development Approval Ingredient (API) Development Sourcing

GENERAL OVERVIEW 01 SERVICE 1 Generic drug manufacturers conduct research to identify brand-name drugs that have lost their patent protection. They study the chemical composition, active ingredients, and therapeutic effects of the original drug. 02 SERVICE 2 Before manufacturing a generic medicine, the manufacturer needs to obtain approval from the regulatory authorities. In most countries, this involves submitting an Abbreviated New Drug Application (ANDA) or similar documentation.

03 ACTIVE PHARMACEUTICAL INGREDIENT (API) SOURCING The manufacturer procures the active pharmaceutical ingredient, which is the chemical substance responsible for the therapeutic effect of the drug. The API can be sourced from various suppliers, ensuring it meets the required quality standards. 04 FORMULATION DEVELOPMENT The manufacturer formulates the generic medicine by combining the API with other inactive ingredients such as fillers, binders, disintegrants, and lubricants. These additional ingredients help create the final dosage form, such as tablets, capsules, or liquids. 05 MANUFACTURING PROCESS The generic medicine is produced in large quantities through a controlled manufacturing process. This involves weighing and mixing the ingredients, granulation (if needed), compression or encapsulation, coating (if applicable), and packaging.

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