Alembic Pharma’s Vadodara Plant Gets VAI Status from US FDA

15 Feb 2025 , 12:00 PM

Alembic Pharmaceuticals Ltd has received an Establishment Inspection Report (EIR) from the US FDA for its solid oral formulation facility (F-4) at Jarod in Vadodara. Following an inspection carried out from Nov 14-22 2024, the facility was cited as being ‘VAI’ (Voluntary Action Indicated).

A VAI classification indicates that some violations were discovered, but they do not require regulatory action, allowing the facility to continue selling previously appr oved drugs and obtain new approvals.

As per the FDA’s guidance, an FDA EIR is sent within 30 days of an inspection detailing the facility’s Good Manufacturing Practice (GMP) non-compliance based on the inspection and the company response. Alembic Pharmaceuticals net profit dropped 23% YoY to ₹138.4 crore in Q3 FY25 from ₹180.4 crore in the same quarter of last year.

In the National Stock Exchange, shares of Alembic Pharma has closed at ₹810 on Friday, which is a 1.91% dip than the previous close. The stock has witnessed a total of 19% dip in the last one year, and 19% dip in the last one month.