Lupin’s Pithampur Unit-3 Receives EIR from the U.S. FDA
Health

Lupin’s Pithampur Unit-3 Receives EIR from the U.S. FDA

Mumbai, November 5, 2025: Lupin Limited, a globally respected pharmaceutical company, announced today that it has received an Establishment Inspection

Matt Ebner
Matt Ebner
2 min read

Mumbai, November 5, 2025: Lupin Limited, a globally respected pharmaceutical company, announced today that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration for its Pithampur Unit-3 plant. The report follows a comprehensive inspection conducted from July 7 to July 17, 2025. The unit manufactures a portfolio that includes metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions.

Speaking on the update, Nilesh Gupta, Managing Director at Lupin, said, “We are delighted to have obtained the EIR for our Pithampur Unit-3 facility. This reflects our unwavering emphasis on compliance, quality control, and operational excellence as we continue providing high-quality, affordable medications manufactured in advanced facilities to patients worldwide.”

About Lupin

Lupin Limited is headquartered in Mumbai and is a prominent name in the global pharmaceutical sector, with operations reaching more than 100 markets. The company’s product range includes branded and generic formulations, complex generics, biotechnology offerings, and APIs. Lupin enjoys a robust presence across therapeutic areas such as respiratory, cardiovascular, diabetes care, infectious diseases, gastrointestinal issues, CNS disorders, and women’s health. With 15 cutting-edge manufacturing facilities, seven R&D centers, and a workforce exceeding 24,000, Lupin advances its mission through Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

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