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.
