Alembic Pharma gets two USFDA observations for Karkhadi facility
New Delhi: Drugs maker, Alembic Pharma recently announced that the company's API facility located at Karkhadi has received Form 483 with two observations from the US health regulators after the inspection of the facility.
The inspection was a scheduled pre-approval inspection and was conducted from 13th January 2020 to 17th January 2020.
At the end of the inspection, the US Food and Drug Administration (USFDA) issued a Form 483 with two observations.
"We would like to inform that the US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Karkhadi from 13th January 2020 to 17th 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," Alembic said.
Headquartered in Gujarat, Alembic Pharma is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be a player in macrolides segment of anti-infective drugs in India.