“This is to inform you that US FDA had conducted a Bioresearch Monitoring (BIMO) inspection at the Company’s Bioequivalence Center located at Taloja, Maharashtra, from 10th March 2025 to 13th March 2025,” Alkem Laboratories said in a regulatory filing.
The inspection concluded that no Form 483 had been issued.
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.Also Read: Exclusive: Alkem Labs in talks to acquire Novartis India from its Swiss parent
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.
The 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.
Also Read: Alkem Labs launches Kojiglo serum in India to treat facial hyperpigmentation
Shares of Alkem Laboratories Ltd ended at ₹4,686.80, down by ₹63.55, or 1.34%, on the BSE.
