Unichem Labs’ Kolhapur API facility inspected by USFDA; 5 procedural observations

Mumbai-based pharma company Unichem Laboratories Ltd on Monday, February 2, said the US Food and Drug Administration (USFDA) has conducted an inspection at its Kolhapur active pharmaceutical ingredients (API) manufacturing facility.

The inspection, carried out between January 27 and February 2, was closed with five observations. The company clarified that all observations relate to procedural aspects and are not linked to data integrity concerns.

In an exchange filing, Unichem said it will submit its

response to the USFDA within the stipulated 15-day timeframe.

Shares of Unichem Laboratories closed at ₹377.95 on the NSE, up 0.68% from the day’s opening price.

On the financial front, the company reported a 20.5% year-on-year decline in net profit for the December quarter at ₹58 crore, compared with ₹73 crore in the same period last year. Revenue, however, rose 14.5% year-on-year to ₹533 crore from ₹466 crore in Q3FY24.

Also Read: Jupiter Life Line Q3: Profit slips 18% despite higher revenue, EBITDA; margins flat

Operating performance improved sharply, with EBITDA more than doubling to ₹85.2 crore from ₹31.6 crore a year ago. EBITDA margins expanded significantly to 16% in the December quarter, compared with 7% in the corresponding period last year, reflecting improved operating leverage and cost efficiencies.