Alkem Lab arm Enzene receives 6 observations after USFDA inspection

Alkem Laboratories has informed that the United States Food and Drug Administration (USFDA) has completed a pre-approval inspection (PAI) at the manufacturing facility of Enzene Biosciences in India (Enzene), a subsidiary of the company in India.

At the conclusion of the inspection, the USFDA issued a Form 483 with 6 procedural observations. Enzene has achieved zero observations related to data integrity a critical validation of Enzens quality systems and the reliability of regulatory filings.

Enzene is currently preparing its response to the USFDA within the stipulated timeline and has initiated appropriate corrective and preventive actions to address the observations.

Alkem Laboratories is engaged in the pharmaceutical business with global operations. The company is engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products.

The companys consolidated net profit rose 2% to Rs 653.53 crore in Q3 FY26, compared with Rs 640.79 crore posted in Q3 FY26. Net sales jumped 10.7% YoY to Rs 3,736.82 crore in the quarter ended 31 December 2025.

Shares of Alkem Laboratories added 1.38% to currently trade at Rs 5,475.85 on the BSE.

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