The US Food and Drug Administration (USFDA) conducted an inspection at Alembic Pharmaceuticals’ Gujarat-based API facility. The inspection was held from January 13-17,2020, the drug firm said in a BSE filing on Tuesday.
This was a scheduled pre-approval inspection at Gujarat’s Karkhadi-based facility and at the end of the inspection, the USFDA issued a form 483 with two observations, the company said.
“The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals active pharmaceutical ingredient (API) facility located at Karkhadi from January 13 to January 17, 2020,” it said.
Last week, Alembic Pharmaceuticals received USFDA’s approval for Empagliflozin tablets, 10 mg and 25 mg. These tablets are indicated as an assistant to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, reports stated.
The firm is actively working on formulas to develop formulations and Active Pharmaceutical Ingredients (APIs). The company expertise in medicines related to anti-infective, analgesic, cough and cold therapies.
On Tuesday, the shares of the company were trading at Rs 600.30 a piece on BSE in morning trade, up 0.26 per cent from the previous close.
(With input from agencies)