Alembic Pharmaceuticals Receives USFDA EIR for Jarod Facility

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).

What Does It Mean?

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.

Establishment Inspection Report (EIR)

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:

• No Action Indicated (NAI): No major issues found.
• Voluntary Action Indicated (VAI): Some violations noted, but no immediate action required.
• Official Action Indicated (OAI): Serious compliance issues requiring regulatory intervention.

Alembic Pharmaceuticals’ Q3 FY25 Performance

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.

Market Movement

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.

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