Lupin gets USFDA EIR for Inhalation Research Center, Florida
Coral Springs & Mumbai: Pharma major Lupin Limited (Lupin) has announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Inhalation Research Center located at Coral Springs, Florida. The facility was inspected by the U.S. FDA, between February 19, 2020, and February 26, 2020, on behalf of the U.K. MHRA for Lupin's generic Fostair application to the U.K. MHRA.
Lupin's Inhalation Research Center at Coral Springs, Florida, inaugurated in August 2015, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.
Commenting on the receipt of the EIR, Vinita Gupta, CEO, Lupin said, "The Inhalation Research Center at Florida was established to develop quality respiratory products to benefit patients across the U.S. and other advanced markets. The receipt of the EIR with satisfactory VAI status validates our commitment towards ensuring the highest levels of quality and CGMP compliance at all our sites. We are grateful for the U.S. FDA's confidence in our team during this critical juncture in the fight against COVID-19 when it has become imperative that we focus on bringing high-quality respiratory products to market."
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 the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas. The Company invests 9.6 % of its revenues on research and development.
Lupin has fifteen manufacturing sites, seven research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.