Lupin Gets US FDA EIR for Nagpur Injectable Plant with VAI Status

Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its injectable manufacturing facility in Nagpur, India. The report carries a Voluntary Action Indicated (VAI) classification, which is considered satisfactory.

Details of the FDA Inspection

The US FDA inspected Lupin’s Nagpur injectable facility between September 8 and September 16, 2025. The EIR was issued after the completion of this inspection, confirming that the regulator found the facility’s operations acceptable, with only voluntary improvements, if any, suggested.

Management’s Comment

Nilesh Gupta, Managing Director of Lupin, said the company is pleased with the outcome of the inspection. He added that Lupin remains focused on maintaining high-quality standards, regulatory compliance, and continuous improvement across all its manufacturing facilities.

About Lupin Limited

Lupin is a global pharmaceutical company headquartered in Mumbai, with products sold in more than 100 countries. The company operates across branded and generic medicines, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs).

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Lupin Share Price Movement

Lupin share price (NSE: LUPIN) closed at ₹2,085.90 on December 16, down ₹6.70 or 0.32% for the day. The stock opened at ₹2,096.60, touched an intraday high of ₹2,099.90 and a low of ₹2,077.60. Lupin’s market capitalisation stands at ₹95.19 lakh crore, with the stock trading at a P/E ratio of 22.09. Over the past year, the share price has moved between a 52-week high of ₹2,402.90 and a 52-week low of ₹1,795.20. The company offers a dividend yield of 0.58%, with a quarterly dividend of ₹3.02 per share.

Conclusion

The US FDA’s EIR with a VAI classification for the Nagpur injectable facility is a positive regulatory development for Lupin. It reinforces the company’s commitment to quality, compliance, and strengthening its injectable business for global markets.

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