U.S. FDA completes its inspection of the Lupin facility in Vizag without making any findings

14 Aug 2023 , 11:50 AM

The United States Food and Drug Administration (U.S. FDA) has finished a Pre-Approval and GMP Inspection of the API production plant Lupin Limited (Lupin) has in Visakhapatnam (Vizag), India. The inspection, which lasted from March 6 to March 10, 2023, was declared to have found nothing.

Nilesh Gupta, Managing Director of Lupin, stated, ‘We are happy with the smooth completion of the inspection at our Vizag site. This success demonstrates our dedication to providing everyone with access to high-quality, reasonably priced healthcare and to upholding global quality standards across all of our manufacturing facilities.

An international pharmaceutical firm with a focus on innovation, Lupin is based in Mumbai, India. The company creates and promotes a wide variety of branded and generic formulations, biotechnology goods, and APIs in more than 100 markets throughout the Americas, Europe, the Middle East, India, and South Africa.

The Company has a strong presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health sectors and holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments. By prescriptions, Lupin ranks as the third-largest pharmaceutical firm in the United States. In FY22, the company spent 8.7% of its revenue on research & development.

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