Alembic Pharmaceuticals Ltd has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its solid oral formulation facility (F-4) at Jarod, Vadodara. The inspection was conducted between November 14-22, 2024, and the facility has been classified under “Voluntary Action Indicated” (VAI).
A VAI classification indicates that while the inspection found certain issues, they do not require immediate regulatory action. The company can continue manufacturing and selling approved drugs and can also receive approvals for new filings.
Any improvements related to the observations are left to the company’s discretion.
The EIR is a standard report issued by the USFDA following an inspection. It is typically sent within 30 days and contains details of the findings. The FDA classifies inspections under three categories:
For the quarter ending December 31, 2024, the company reported a 23% year-on-year decline in net profit at ₹138.4 crore, compared to ₹180.4 crore in the same quarter last year. However, revenue from operations saw a 3.8% increase, reaching ₹1,692.7 crore from ₹1,630.6 crore in Q3 FY24.
On February 14, Alembic Pharmaceuticals’ shares closed at ₹809, down ₹17.20 (2.08%) from the previous session. As of 12:00 PM on February 17, the shares were trading at ₹801.10, down ₹17.05 (2.08%) for the day. Over the past month and year, the stock has dropped by 19%.
The EIR confirms the completion of the inspection, with Alembic Pharmaceuticals now expected to address the findings voluntarily.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.
Investments in the securities market are subject to market risks, read all the related documents carefully before investing.
Published on: Feb 17, 2025, 3:19 PM IST
Team Angel One
We're Live on WhatsApp! Join our channel for market insights & updates