Sakar Healthcare’s OSD, API blocks get WHO GMP approval from FDCA

12 Oct 2022 Evaluate

Sakar Healthcare’s oncology Oral Solid Dosage (OSD) and Active Pharmaceutical Ingredient (API) manufacturing blocks, which are a part of its research-driven API-integrated oncology formulation manufacturing unit located at Bavla, Gujarat, India, have received WHO GMP approval from Food & Drugs Control Administration (FDCA), Gujarat. The regulatory authority has certified both the above mentioned units complying to Good Manufacturing Practices (GMP) with cytoxic category of drugs.

This certification has enabled Sakar Oncology unit to Trigger for manufacturing unit audits (OSD finished formulations and APIs) by regulatory bodies of multiple countries, a pre-requisite to export these product and to utilize glass-line reactors/assembly to develop and supply high potent API (HPAPI) to prospects and partners in anti-cancer segment. To manufacture and supply the big brands in tablets/capsules for renowned players in the segment at international level.

Sakar Healthcare is an Indian pharmaceutical company engaged in the manufacturing and marketing of its own pharmaceutical formulations for domestic and international markets.

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