Lupin has good news to share today morning. The company said that it has received the Establishment Inspection Report (EIR) from the U.S. FDA for its Inhalation Research Center located at 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.”
Prior to this, Friday evening after market closure, the company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHPM) has adopted a positive opinion and recommended approval of Nepexto, a biosimilar to Enbrel (Etanercept). The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for member countries of the EU. The decision on the EC’s approval is expected in May 2020.
These two approvals have greatly cheered up the stock. From its close of Rs.547 on Friday, it opened today at Rs.564, going up to an intraday high at Rs.573.65 and it continues to remain in the positive.