Global pharmaceutical giant Lupin Limited (Lupin) said today that it received the United States Food and Drug Administration’s (U.S. FDA) Establishment Inspection Report (EIR) for its Pithampur (Madhya Pradesh) Unit-1 manufacturing plant, which produces both APIs and final goods. Following a facility inspection conducted from September 16 to September 27, 2024, the EIR was given with an inspection classification of Voluntary Action Indicated (VAI).
“We are pleased to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a satisfactory VAI classification,” stated Nilesh Gupta, Managing Director of Lupin. This illustrates our dedication to the greatest levels of compliance and quality.
About Lupin
With its headquarters located in Mumbai, India, Lupin Limited is a leading pharmaceutical company with medicines supplied in more than 100 markets worldwide. Lupin specialises in pharmaceutical products, including as active pharmaceutical ingredients, complicated generics, branded and generic formulations, and biotechnology products. The company, which is trusted by consumers and healthcare experts worldwide, has a strong presence in both India and the United States in a number of therapeutic areas, such as women’s health, respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, and central nervous system. With 15 cutting-edge production facilities and 7 research facilities worldwide, Lupin employs more than 22,000 committed specialists. Through its businesses, Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, Lupin is dedicated to enhancing patient health outcomes.
