Alembic Pharmaceuticals has received a formal warning letter from the U.S. Food and Drug Administration targeting its bioequivalence research facility in Vadodara, India.
The warning letter, dated July 10, 2026, follows an FDA inspection of the Alembic Research Centre Bioequivalence facility conducted between March 3 and March 7, 2025.
The inspection had previously resulted in a Form 483, a less severe regulatory notice, before the agency escalated its concerns to a full warning letter this week.
The FDA’s core allegation centres on Alembic’s failure to properly obtain informed consent from participants involved in an in vivo bioequivalence study at the site.
The agency alleges that Alembic “failed to seek informed consent” for its bioequivalence study “under circumstances that provided the prospective subject or representative with sufficient opportunity or information to consider whether to participate and that minimized the possibility of undue influence.”
The FDA’s concern focuses specifically on the Informed Consent Form used during the study, rather than on broader data integrity issues at the facility.
Alembic confirmed that the observations relate solely to the Informed Consent Form and do not concern data integrity or restrict the operations of its Bioequivalence Facility.
The warning letter was issued to the Clinical Investigator associated with the bioequivalence study, and the identity of the investigational drug involved has been redacted from publicly available documentation.
Bioequivalence studies are a critical component of the generic drug approval process, typically required to demonstrate that a proposed generic copy performs comparably to its branded reference product in the body.
In guidance issued to generic drugmakers, the FDA has clarified that the focus of most bioequivalence studies falls on “the release of the drug substance from the drug product into the systemic circulation.”
Alembic disclosed the completion of the original March inspection to stock exchanges on March 7, 2025, in line with its regulatory reporting obligations.
The company said that, based on its preliminary assessment, the regulatory action does not impose any restrictions on the operations of its Bioequivalence Facility and is not expected to have any material financial impact at this stage.
Alembic added that it is evaluating the matter and is coordinating with the Clinical Investigator to submit an appropriate response to the FDA.
The company did not immediately respond to requests for comment on the warning letter or provide further details regarding the redacted product at the centre of the study.