Alkem Laboratories announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) on 13 February, 2026 at the manufacturing facility of Enzene Biosciences (Enzene), a subsidiary of the Company in India located at Chakan, Pune.
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 Enzene's quality systems and the reliability of regulatory filings.
Enzene is in the process of preparing and submitting its response to the USFDA within the stipulated timeline and has initiated appropriate corrective and preventive actions.