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Lupin Shares Hit 52-Week High on Receiving USFDA Clearance for Nagpur Unit

Lupin Ltd
The US FDA issued the EIR after conducting an inspection at the Nagpur facility between 8 and 16 September.

Lupin shares hit a 52-week high of Rs 1,184.70 on 29 September after the company received an Establishment Inspection Report for its Nagpur unit-I manufacturing facility from the USFDA (U.S. Food and Drug Administration).

The EIR (Establishment Inspection Report) indicates the closure of an inspection that classified Lupin’s Nagpur unit as VAI (Voluntary Action Indicated).

The USFDA had issued Form-483 with two observations for Lupin’s Nagpur oral solid dosage facility in July earlier this year.

Nilesh Gupta, Managing Director, Lupin, said, β€œWe are pleased to receive the EIR with a VAI status from the U.S. FDA for the recent inspection of our Nagpur Unit-1 facility. This achievement underscores our commitment to quality and compliance and also mirrors our core values, reaffirming our commitment to providing high-quality healthcare solutions to our patients around the world.”

The company said in its Q1FY24 earnings meeting that it has cleared three sites that were previously under the USFDA’s warning letter and is focused on remediation efforts for Mandideep and Tarapur sites.

At 3:30 pm, the shares of Lupin closed at Rs 1,168.35 or 3.12% above its previous close on NSE.

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