Coral Springs, Florida, Mumbai, India: Pharma major Lupin Limited (Lupin) announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Inhalation Research Center (IRC) 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 (IRC) 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.
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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.”