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 IndiaIssued Jul 10, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations6
Issue DateJul 10, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
Location
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
FEI Number
N/A
Country
India
Issue Date
July 10, 2026
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
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