Recipient Name Pratik Doshi, M.D., Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., Alembic Research Centre Bioequivalence Facility, Alembic Road Next to Bhailal Amin General Hospital Gorwa Vadodara 390003 Gujarat India
Issue DateJuly 10, 2026
FEI NumberN/A
Violations6
CountryIndia
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. FDA Warning Letter, July 10, 2026