USFDA conducts inspection at Alembic Pharmaceuticals’ API Facility at Karkhadi

18 May 2018 Evaluate

The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ API Facility located at Karkhadi from May 14, 2018 to May 18, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with one observation.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company now has a total of 71 ANDA approvals (63 final approvals and 8 tentative approvals) from USFDA.

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