Lupin’s Dabhasa Facility Receives FDA Approval with Zero Observations

Lupin Ltd announced in a stock exchange filing that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility in Dabhasa, Gujarat. This report follows an inspection conducted from April 8 to April 12, 2024, which concluded with no observations. The facility received an inspection classification of “No Action Indicated” (NAI), indicating full compliance with U.S. FDA standards.

This manufacturing unit is part of Lupin Manufacturing Solutions (LMS), which specialises in the development, manufacture, and sale of Active Pharmaceutical Ingredients (APIs) and Contract Development and Manufacturing Operations (CDMO). The successful inspection and subsequent EIR reinforce Lupin’s commitment to maintaining high-quality manufacturing standards and regulatory compliance, enhancing its reputation in the global pharmaceutical market. This significant achievement is a testament to the company’s dedication to excellence in its manufacturing processes and operations.

Speaking of the significant development, the Managing Director of Lupin Ltd, Nilesh Gupta, said, “We are pleased to receive the EIR for Dabhasa from the U.S. FDA. This achievement is in line with our continued focus and commitment to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of delivering high-quality, affordable healthcare solutions to our patients globally.”

Earlier in June, the company received the Establishment Inspection Report from the United States Food and Drug Administration for its manufacturing facility in Somerset, New Jersey, with a Voluntary Action Indicated (VAI) status. This facility was inspected from May 7 to May 17, 2024.

About Lupin Ltd 

Lupin is an innovation-driven global pharmaceutical company based in Mumbai, India. It develops and markets a diverse portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) across more than 100 markets, including the U.S., India, South Africa, as well as the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

On July 15, 2024, the share price of Lupin Ltd opened at ₹1,819.95, touching the day’s high at ₹1,825.00, as of 9:32 AM on the NSE.

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