Alembic Pharma Gets USFDA Warning Letter for Vadodara Facility

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Jul 13, 2026 19:13

Alembic Pharmaceuticals received a USFDA warning letter for its Vadodara bioequivalence facility regarding an informed consent form observation. No data integrity issues or operational restrictions.

New Delhi, Jul 13 (PTI) Alembic Pharmaceuticals Ltd on Monday said the US health regulator has issued a warning letter following the inspection of its bioequivalence facility at Vadodara, regarding the informed consent form.

The US Food and Drug Administration (USFDA) had conducted inspection from March 3, 2025, to March 7, 2025, at the company's bioequivalence facility at Vadodara in Gujarat, Alembic Pharmaceuticals said in a regulatory filing.

The company has been made aware that the US Food and Drug Administration (USFDA) has issued a warning letter dated July 10, 2026, to the Clinical Investigator associated with a bioequivalence study conducted at the company's bioequivalence facility, it added.

The warning letter pertains to an observation regarding the informed consent form (ICF) in relation to a bioequivalence study. The observations do not relate to data integrity, it added.

It does not impose any restriction on the operations of the company's bioequivalence facility. The company is coordinating with the Clinical Investigator for submission of an appropriate response to the USFDA within the stipulated timeline, Alembic Pharmaceuticals said.

As per the USFDA, ICF is the form on which a prospective subject signs for participation in a clinical investigation, after being provided all the requisite information under well-defined rules.

Source: PTI By Rediff Money Desk, New Delhi

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