The certificate, valid for three years from the inspection date of December 9, 2025, confirms compliance with European Union Good Manufacturing Practices (EU GMP). The approval follows a prior inspection by the Malta Medicines Authority, as noted in Alkem’s December 10, 2025, disclosure.
This week, Alkem Laboratories said it has received an allotment letter dated March 18, 2026, from DMIC Vikram Udyogpuri Ltd for approximately 30 acres of land in Phase 2 of the industrial area in Ujjain, Madhya Pradesh, for setting up a greenfield formulations manufacturing facility.
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The company’s board of directors has approved an investment of up to ₹533 crore for the project, which will be executed in a phased manner. The land has been allotted in the Industrial Area developed by DMIC Vikram Udyogpuri Ltd in Ujjain. The proposed facility will be a formulation manufacturing unit.
Third Quarter Results
Alkem Laboratories reported a 5% year-on-year rise in net profit at ₹626 crore in the December quarter. The company reported ₹595 crore profit in the corresponding quarter of the previous year. Revenue from operations was up marginally by 1.5% year-on-year to ₹3,374 crore in the quarter under review, as against ₹3,324 crore in the same quarter last year.
Earnings before interest, tax, depreciation, and amortisation or EBITDA climbed 7.4% to ₹759 crore, compared to ₹707.4 crore in the year-ago period. EBITDA margin expanded by 120 basis points to 22.5%, compared to 21.3% last year. For the first nine months of FY25, EBITDA margin stood at 21.6% as against FY25 guidance of 18.5-19%.
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Overall contribution of the US sales to total sales stood at 19.1% in the quarter. During the quarter, the company received two approvals from the USFDA, including one tentative approval. Other international market sales contributed 9.8% to total sales in Q3FY25. The company has a presence mainly in Latin America, Australia and Europe.
Shares of Alkem Laboratories Ltd ended at ₹5,284.50, up by ₹43.70, or 0.83%, on the BSE.
