Materials Management for Bulk Drug Intermediates

General Controls There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of materials. Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials. Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the quality […]

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Bulk Drug Intermediates – A Market Review

Bulk drug intermediates are the drugs used as raw materials for the production of bulk drugs, or they can refer to a material produced during synthesis of an API that must undergo further molecular change or processing before it becomes an API. Drug intermediates are hygienically formulated using high grade raw materials and they are […]

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Government of India promotes bulk drugs parks and curbs imports to boost manufacturing in India

In a bid to revive India’s active pharmaceutical ingredient (API) and bulk drug market, the government is contemplating restrictions on the import of APIs and has suggested setting up of mega bulk drug parks, a move that is expected to boost domestic production. In the draft pharmaceutical policy framed by the Department of Pharmaceuticals under […]

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Emerging Trends in Bulk Drug Industry

At the time of Independence the bulk drug industry in the country had a meagre investment of Rs. 10 crores, producing a few bulk drugs valued at only Rs. 26 crores. Most of the bulk drugs and formulations were being imported from other countries. But now the industry has grown to proportions where investment has […]

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