Alembic Pharmaceuticals on Thursday announced that United States Food and Drug Administration (USFDA) has conducted an inspection at the drug maker's Injectable Facility (F-3) located at Karkhadi from 18 August 2022 to 30 August 2022.
The pharmaceutical company said that the US drug regulator has issued a Form 483 with 2 observations.
None of the observations are related to data integrity and management believes that they are addressable, the drug maker stated.
The company said that it is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The company is committed to maintain the highest quality standards and compliance at all times, it added.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
The company reported a cconsolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.
Shares of Alembic Pharmaceuticals were down 0.35% to Rs 645.85 on the BSE.
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