Unichem Labs slides after receiving three USFDA observations at Roha facility

Unichem Laboratories declined 1.36% to Rs 578.60 after the company announced that its Roha active pharmaceutical ingredient (API) facility has received three observations from the United States Food and Drug Administration (USFDA).

In a regulatory filing, the company stated that the USFDA conducted the inspection from 16 June to 20 June 2025. At the conclusion of the inspection, the USFDA issued three observations, which were primarily related to procedural changes, with none related to data integrity.

The company stated that it will provide the necessary response to the USFDA within the stipulated 15-day period.

The official announcement was made on Saturday, 21 June 2025.

Unichem Laboratories is engaged in the manufacturing of pharmaceutical products.

The company reported a consolidated net profit of Rs 52.97 crore in Q4 FY25, compared with a net loss of Rs 129.31 crore in Q4 FY24. Revenue from operations jumped 36% year-on-year to Rs 587.18 crore in Q4 FY25.

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