According to reports from CNBC TV18, PTI, and the latest USFDA communication, Alembic Pharmaceuticals announced on Monday (July 13) 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 in Vadodara. The company became aware of the warning letter on July 12, 2026, following a USFDA inspection conducted between March 3, 2025 and March 7, 2025. As per PTI, the USFDA had conducted inspection from March 3, 2025, to March 7, 2025, at the company's bioequivalence facility at Vadodara in Gujarat. The company has now submitted the necessary details to the stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
As reported by CNBC TV18, PTI, and the latest USFDA communication, the warning letter pertains to observations related to the Informed Consent Form (ICF) in connection with a bioequivalence study. The company emphasized that the observations do not relate to data integrity, which is a more serious regulatory concern for pharmaceutical facilities. According to PTI, the 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. The latest USFDA communication confirms that these observations specifically relate to the Informed Consent Form used during the bioequivalence study.
According to CNBC TV18, PTI, and the latest USFDA communication, 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 stated it is coordinating with the clinical investigator for submission of an appropriate response to the USFDA within the stipulated timeline. The latest communication confirms that no restrictions on the Bioequivalence Facility operations have been imposed as a result of this regulatory action. The company added that it is reviewing the matter and working closely with the clinical investigator to submit an appropriate response to the USFDA within the prescribed timeline.
As reported by CNBC TV18, PTI, and the latest USFDA communication, the company added that no material financial impact has been identified at this stage. The company is evaluating the matter and coordinating with the clinical investigator in relation to the response to the USFDA. Shares of Alembic Pharmaceuticals Ltd ended at ₹830.65, down by ₹6.75, or 0.81%, on the BSE following the announcement. The latest USFDA communication indicates that the company is currently coordinating with the Clinical Investigator to submit an appropriate response to the USFDA within the stipulated timeline.
Last month, Alembic Pharmaceuticals received final approval from the USFDA for its abbreviated new drug application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. With this approval, Alembic Pharmaceuticals' cumulative USFDA approvals stand at 243 ANDAs, comprising 223 final approvals and 20 tentative approvals. The approved product is the generic equivalent of Hoffmann-La Roche's Tamiflu Oral Suspension, 6 mg/mL, used for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older, as well as for the prevention of influenza A and B in patients aged one year and above. According to IQVIA data, the product has an estimated US market size of $27 million for the 12 months ended March 2026.
