USFDA inspection at the manufacturing facility of Enzene Biosciences Limited

The United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) on 13th February, 2026 at the manufacturing facility of Enzene Biosciences Limited ("Enzene"), a subsidiary of Alkem Laboratories Limited 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.

Shares of Alkem Laboratories Limited was last trading in BSE at Rs. 5480.30 as compared to the previous close of Rs. 5401.55. The total number of shares traded during the day was 103601 in over 639 trades.

The stock hit an intraday high of Rs. 5538.35 and intraday low of 5384.50. The net turnover during the day was Rs. 568264910.00.

Source : Equity Bulls

Keywords

AlkemLaboratories INE540L01014 Pharmaceuticals USFDA Inspection EnzeneBiosciences