Lupin has recently informed exchanges that the company received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Pithampur Unit-1 manufacturing facility. The plant, which produces both active pharmaceutical ingredients (APIs) and finished products, was inspected by the FDA from September 16 to September 27, 2024.
The FDA issued the EIR with a Voluntary Action Indicated (VAI) classification, which signals that while the facility complies with regulatory requirements, certain actions may be voluntarily undertaken by the company to ensure continued adherence to the FDA’s quality standards.
Nilesh Gupta, Managing Director, Lupin stated, “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.”
Headquartered in Mumbai, India, Lupin Limited is a trusted global pharmaceutical company, operating in over 100 markets. Specializing in branded and generic formulations, biotechnology products, active pharmaceutical ingredients, and complex generics, Lupin has a strong presence in the U.S. and India. The company serves multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
