The United States Food and Drug Administration (USFDA) conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' solid oral formulation facility (F-4) located at Jarod in Gujarat.
The USFDA issued a Form 483 with 5 procedural observations. None of the observations are related to data integrity and management believes that they are addressable.The company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.
The scrip shed 0.64% to Rs 580 on the BSE.
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