Alembic Pharmaceuticals's API facility at Karkhadi concludes USFDA pre-approval inspection

With two observations under Form 483

Alembic Pharmaceuticals announced that the US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Karkhadi from 13 January, 2020 to 17 January, 2020. This was a scheduled pre-approval inspection and at the end of the inspection, the USFDA issued a Form 483 with two observations.

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