By: IPP Bureau
Last updated : March 07, 2025 9:06 pm
USFDA inspection at Alembic Pharma's Bioequivalence facility
USFDA inspection at Alembic Pharma's Bioequivalence facility
The United States Food and Drug Administration (USFDA) has conducted an inspection at our Bioequivalence Facility located at Vadodara from 3rd March, 2025 to 7th March, 2025. This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation. The company will provide comprehensive response to USFDA for the observations within the stipulated period.
EDQM issues CEP Certificate for IOL Chemicals and Pharmaceuticals’ API Quetiapine Fumarate
European Directorate for the Quality of Medicines & Health Care (EDQM) has issued a Certificate of Suitability for IOL Chemicals and Pharmaceuticals’ API product "Quetiapine Fumarate" on 4th March 2025.
This certification will enable the Company to export Quetiapine Fumarate to European and other countries that accept CEPs. Quetiapine Fumarate is an antipsychotic drug which is widely used to treat various mental health disorders.