Mumbai, January 8, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-1 manufacturing facility that manufactures both APIs and finished products. The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024.

Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a satisfactory VAI classification. This reflects our commitment to the highest standards of quality and compliance.”

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact:

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com