USFDA inspects Alembic Pharma’s Gujarat-based API facility
This was a scheduled pre-approval inspection at Gujarat’s Karkhadi-based facility and at the end of the inspection.
Alembic Pharmaceuticals on Monday said no observations were issued by US health regulator USFDA after inspection of its Baroda facility.
The bio-equivalence facility was inspected by US Food & Drug Administration (USFDA) from March 6-10; March 13-17 and April 10-12, Alembic said in a filing to BSE.
“There were no 483s issued by USFDA at the end of the inspection,” it added.
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USFDA issues Form 483 observations to a firm's management at the conclusion of an inspection to notify it of objectionable conditions at the facility.
It is issued when investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Alembic stock was trading at Rs.626.80, up 0.35 per cent, in the afternoon trade on BSE.
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