Shares of Unichem Laboratories fell 4.19% to Rs 562.05 during trading today after the company disclosed that the US Food and Drug Administration (USFDA) made three observations during its recent inspection of the firm’s Roha API (Active Pharmaceutical Ingredient) facility.
In an exchange filing dated June 21, 2025, the company stated that the USFDA inspection took place from June 16 to June 20. While the inspection concluded with three observations, Unichem clarified that the issues were procedural in nature and not related to data integrity—a critical area in pharmaceutical compliance.
Unichem Laboratories assured investors that it will submit its formal response to the USFDA within the stipulated 15-day period.
Despite the company’s clarification that the concerns raised are not severe, investor sentiment appears to have been impacted. The stock was trading at Rs 562.05 on the BSE, down 4.19% for the day.
This inspection and the resulting observations are significant as USFDA compliance is crucial for maintaining export approvals to the United States, one of the major pharmaceutical markets.
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