The company became aware of the warning letter on July 12, 2026. The USFDA inspection of the facility was conducted between March 3, 2025 and March 7, 2025. The warning letter pertains to observations related to the Informed Consent Form (ICF) in connection with a bioequivalence study.
Alembic Pharmaceuticals said the observations do not relate to data integrity. Based on its preliminary assessment, the warning letter does not impose any restriction on the operations of the company’s Bioequivalence facility.
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The company said it is coordinating with the clinical investigator for submission of an appropriate response to the USFDA within the stipulated timeline.
Alembic Pharmaceuticals said, “Based on the company’s preliminary assessment, the warning letter does not impose any restriction on the operations of the company’s Bioequivalence facility.”
The company added, “No material financial impact has been identified at this stage. The company is evaluating the matter and is coordinating with the clinical investigator in relation to the response to the USFDA.”
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Shares of Alembic Pharmaceuticals Ltd ended at ₹830.65, down by ₹6.75, or 0.81%, on the BSE.
First Published: Jul 13, 2026 7:35 PM IST
