Lupin Receives U.S. FDA Establishment Inspection Report for Somerset Facility

Lupin Receives U.S. FDA Establishment Inspection Report for Somerset Facility

Lupin Receives U.S. FDA Establishment Inspection Report for Somerset Facility​

Global pharmaceutical major Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) regarding its manufacturing facility located in Somerset, New Jersey. The report carries a Voluntary Action Indicated (VAI) classification.

The inspection of the facility was conducted by U.S. FDA officials between April 13, 2026, and April 17, 2026.

Nilesh Gupta, Managing Director of Lupin, stated that the receipt of the VAI classification from the U.S. FDA for the Somerset facility underscores the company's dedication to operational excellence and compliance. He added that this outcome reinforces their commitment to manufacturing high-quality medicines trusted by patients globally.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed across more than 100 markets worldwide. The company specializes in various pharmaceutical products, including branded and generic formulations, complex generics, active pharmaceutical ingredients, biotechnology products.

Lupin maintains a strong presence in the US and India, serving multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, gastrointestinal, central nervous system, and women's health. The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce exceeding 24,000 professionals. Lupin is also committed to improving patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

LUPIN Stock Price Movement​

On Wednesday, Lupin Limited shares shed 0.90% in the market, closing at ₹2397.5. The stock traded during the session within a range of ₹2392 to ₹2443.4.
 

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