Lupin Secures US FDA Nod for Pithampur manufacturing facility

Pharmaceutical firm Lupin Ltd has stated 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, which produces both APIs and finished goods.

"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," the company said in a statement to the stock exchanges.

Lupin, based in Mumbai, distributes its products across more than 100 markets, as stated in its press release. The pharmaceutical giant focuses on items such as branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The firm operates 15 production facilities and 7 research centers worldwide, employing more than 22,000 individuals at these locations. Lupin was established in 1968 by Desh Bandhu Gupta,[11] a chemistry professor at BITS-Pilani, located in Rajasthan.

“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," the company's Managing Director Nilesh Gupta said after the FDA classification.