Alkem Labs' Taloja Bioequivalence Center Clears USFDA Inspection

16 Mar 2025 , 10:04 PM

On March 13, Alkem Laboratories Ltd informed the stock exchanges that the Bioresearch Monitoring (BIMO) inspection at its Bioequivalence Center located in Taloja, Maharashtra was conducted by the United States Food and Drug Administration (USFDA).

This inspection, conducted from March 10 through March 13, 2025, was to evaluate compliance with the legal standards concerning bioequivalence studies. The inspection successfully concluded with zero Form 483 observations as per USFDA requirements.

Alkem Laboratories has announced a 5% year-on-year (YoY) rise in net profit at ₹626 crore for the December 2024 quarter, as against ₹595 crore in the same period of the previous financial year.

Revenue from operations for the company posted a slight growth of 1.5% YoY, coming in at ₹3,374 crore as compared to ₹3,324 crore in the same quarter last year. EBITDA grew 7.4% for the year to ₹759 crore in the quarter from ₹707.4 crore in the corresponding quarter last year. EBITDA margin expanded 120bps from 21.3% in the corresponding period last year to 22.5%, indicating an improvement in profitability.

Alkem’s sales in the quarter were significantly boosted by its US market, Currently Alkem contributing 19.1% of total sales in the quarter, confirming its solid footing within the international pharmaceutical space. Alkem Laboratories received two approvals from the USFDA, which included a tentative approval during the quarter, increasing the total number of products under its pipeline to the regulated markets.