Alkem Laboratories' arm Enzene Biosciences receives 6 US FDA observations, no data integrity issues
Published on 16/02/2026 06:22 PM
Alkem Laboratories' arm Enzene Biosciences receives 6 US FDA observations, no data integrity issuesShares of Alkem Laboratories Ltd ended at ₹5,475.55, up by ₹74.00, or 1.37%, on the BSE.By Jomy Jos Pullokaran February 16, 2026, 6:22:56 PM IST (Published)2 Min ReadAlkem Laboratories Ltd on Monday (February 16) said the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its subsidiary, Enzene Biosciences Limited, located in Chakan, Pune, on 13th February 2026.
At the conclusion of the inspection, the USFDA issued a Form 483 with six procedural observations. Enzene recorded zero observations related to data integrity, validating the quality systems and reliability of regulatory filings at the facility.
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Enzene is preparing and submitting its response to the USFDA within the stipulated timeline and has initiated appropriate corrective and preventive actions.
Third Quarter Results
Net profit rose 1.6% year-over-year to ₹636 crore from ₹625.8 crore, in line with estimates. Revenue climbed 10.7% to ₹3,737 crore compared to ₹3,374 crore last year, driven by revenue from international markets.
Earnings before interest, tax, depreciation, and amortisation (EBITDA) increased 9% to ₹826.8 crore from ₹759.2 crore, though margins dipped marginally to 22.1% versus 22.5%. Also, it declared an interim dividend of ₹43 a share, the highest in the company's history.
Also Read: Alkem Labs Q2 Results: Strong India, US sales lift revenue; profit, margins improve
The Mumbai-based pharmaceuticals company also revealed a plan to acquire a majority stake in Occlutech Holding, a loss-making Swiss company that manufactures minimally invasive cardiac devices valued at €180 million, for cash before June 30, 2026.
Shares of Alkem Laboratories Ltd ended at ₹5,475.55, up by ₹74.00, or 1.37%, on the BSE.Continue Reading(Edited by : Jomy Jos Pullokaran)TagsAlkem Laboratoriesshare market todayUS FDA