Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Global pharma major Lupin Limited (Lupin) on Monday announced that it has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for its API (active pharmaceutical ingredient) manufacturing facility located in Visakhapatnam.

The facility received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 and March 10.

Nilesh Gupta, Managing Director, Lupin, said, “We are happy to have received the EIR for our Vizag facility from the US FDA."

He said that Lupin is committed to ensuring high quality of products and safety of manufacturing processes.

Lupin is a transnational pharmaceutical company headquartered in Mumbai. It develops branded and generic formulations, biotechnology products, and APIs in over 100 markets in India, the US, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 7.9 per cent of its revenue in research and development in FY23. It has been consistently recognised as a ‘great place to work’ in the biotechnology and pharmaceutical sectors.

The company has 15 manufacturing sites, seven research centres, and over 20,000 professionals working globally.