Alembic Pharmaceuticals receives two observations for Karakhadi Injectable Facility

19 Feb 2026 Evaluate

Alembic Pharmaceuticals has received two observations from United States Food and Drug Administration (USFDA) for its Injectable Facility (F-3) located at Karakhadi. The USFDA has conducted an unannounced cGMP inspection at the said facility from February 9, 2026 to February 18, 2026. None of the observations are related to data integrity.

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.

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