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Briefs on Alembic Pharma and IOL Chemicals and Pharmaceuticals

Briefs on Alembic Pharma and IOL Chemicals and Pharmaceuticals

Mar 08, 2025

USFDA Inspection at Alembic Pharma’s Bioequivalence Facility SFDA Inspection at Alembic Pharma’s Bioequivalence Facility The United States Food and Drug Administration conducted an inspection of our Bioequivalence Facility in Vadodara between 3rd and 7th March 2025. This was a planned inspection. The USFDA issued Form 483, which included one procedural observation. The company will respond to USFDA's observations in a comprehensive manner within the specified time frame. EDQM Issues CEP Certificate for IOL Chemicals and Pharmaceuticals API Quetiapine Fumarate The European Directorate for the Quality of Medicines & Health Care's (EDQM), has issued a Certificate of suitability for IOL Chemicals and Pharmaceuticals API product "Quetiapine Fumarate", on the 4th of March 2025. This certification will allow the Company to export Quetiapine Fumarate into European countries and other countries who accept...

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