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Lupin's Nagpur Facility Receives EIR from U.S. FDA

Lupin's Nagpur Facility Receives EIR from U.S. FDA

Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U.S. FDA inspection of its Nagpur, India facility. The inspection for the facility was carried out by the U.S. FDA between January 6, 2020 and January 10, 2020.


Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are very happy to have received the EIR for our Nagpur facility, our largest and most advanced oral solid dosage facility. We remain committed to enhancing compliance and quality standards across all our manufacturing sites.”

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 enjoys leadership position 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. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin's Nagpur Facility Receives EIR from U.S. FDA

Darshana

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More news about: quality / gmp | Published by Darshana | April - 13 - 2020 | 127

 

 

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