Alkem Laboratories’ Bioequivalence Center clears US FDA inspection without observations

Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug Administration (US FDA) conducted a Bioresearch Monitoring (BIMO) inspection at its Bioequivalence Center in Taloja, Maharashtra, from March 10 to March 13, 2025.”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 parentRevenue 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.