Global pharma major Lupin Ltd. has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US 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.

Commenting on the development, 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.”

Lupin is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company enjoys a strong position in India and the US 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 centres globally.