Biocon, which had closed yesterday at Rs.270.60, opened higher at Rs.280 and even went on to an intraday high at Rs.285.40. It is currently off the days high is at Rs.275 levels.
Today morning the company announced its subsidiary, Biocon Sdn Bhd, has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine.
The inspection was conducted between Feb 10 and Feb 21, 2020 and was closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020.
The closing of the USFDA Inspection of its Malaysia facility is an important milestone in its journey of developing Insulin Glargine for patients in the US. Its Insulin Glargine (Semglee) application filed by its partner Mylan, with the USFDA under NDA pathway, is currently under review.