Lupin gets EIR from USFDA for Goa facility

Published On 2021-12-14 06:43 GMT | Update On 2021-12-14 12:17 GMT

Mumbai: Global pharma major Lupin Limited today announced that the company has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021.

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

"We are very happy to have received the EIR from US FDA with Voluntary Action Indicated classification for our Goa plant. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We are committed to manufacture and supply products of the highest quality from all our manufacturing sites." said Vinita Gupta, CEO, Lupin.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said "This is a very positive development and we are delighted with the news of the change in classification of our Goa site. The Goa site has a very important place in the U.S. market with the number of affordable, quality medicines we supply, and we now look forward to new products flowing out of the site again. We remain committed to meet and exceed global standards of quality and compliance at all our manufacturing facilities globally."

Earlier, the company had received 7 observations from the US health regulator after an inspection at its Goa facility.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Lupin gets EIR from USFDA for Goa facility

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