Alkem Laboratories Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

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.

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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 Enzen?s 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 company?s 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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Alkem Laboratories announced that the Board of Directors of the Company at its meeting held on 13 February 2026, inter alia, have recommended the interim dividend of Rs 43 per equity Share (i.e. 2150%) , subject to the approval of the shareholders.

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Net profit of Alkem Laboratories rose 1.63% to Rs 636.02 crore in the quarter ended December 2025 as against Rs 625.82 crore during the previous quarter ended December 2024. Sales rose 10.74% to Rs 3736.82 crore in the quarter ended December 2025 as against Rs 3374.28 crore during the previous quarter ended December 2024.

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