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Alembic Pharmaceuticals gets EIR from USFDA for Injectable facility in Gujarat

14 May 2026 Evaluate

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its Injectable facility (F-III) located at Karakhadi, Gujarat on May 13, 2026. 

Earlier, the USFDA had conducted an unannounced cGMP inspection from February 9, 2026 to February 18, 2026. The inspection had been completed with two observations, and none of the observations were related to data integrity. 

Alembic Pharmaceuticals is principally engaged in the manufacturing and selling of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.

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