Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company’s API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90.
The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors.
The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are “addressable” and reiterated its commitment to maintaining high standards of quality and regulatory compliance.
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