
USFDA16 Sept 2026, 06:11 pm
Alembic Pharma: USFDA Closes Inspection of Bioequivalence Facility
AI Summary
Alembic Pharmaceuticals Ltd has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), confirming the closure of the inspection conducted at its Bioequivalence Facility in Vadodara, Gujarat. The inspection took place from March 3rd to March 7th, 2025. This closure signifies regulatory compliance and is a positive development for the company's operations and product approvals in the US market.
Key Highlights
- USFDA inspection at Vadodara Bioequivalence Facility is closed.
- Establishment Inspection Report (EIR) issued by USFDA.
- Inspection period was March 3rd to March 7th, 2025.
- Positive regulatory outcome for Alembic Pharmaceuticals.
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