Date: 11th September, 2026
Regulatory Compliance Update
Alembic Pharmaceuticals Limited has successfully completed an unannounced onsite Bioequivalence inspection conducted by the United States Food and Drug Administration (USFDA) at the Company's Bioequivalence Facility located in Vadodara, Gujarat.
The inspection resulted in no Form 483 observations, indicating full compliance with USFDA regulatory standards.
The inspection period was from 31st August, 2026 to 10th September, 2026 (11 days).
Company Representative
The disclosure was signed by Chirag K. Shukla, Company Secretary of Alembic Pharmaceuticals Limited, with digital signature timestamped on 11th September, 2026 at 11:17:21 IST.