Biocon has been gaining for the last 3 days and has risen 3.38% in the period. The stock opened higher by 1% at Rs.225 and rose further to Rs.225.85, its intraday high. It barely remains in the green as the overall mood on the street seems to have affected the stock too.
The company announced today morning that its Malaysian unit has eceived the Certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland).
This approval expands Biocon’s capacities multi-fold with the new large scale devices facility coming up to speed to serve the growing needs of people with diabetes in EU.
The Malaysia site was inspected in May 2019 and the certificate of GMP compliance received now reflects that the agency considers the manufacturing facilities for Drug Substances, Drug Products and Insulin Delivery Devices to be in compliance with the guidelines of Good Manufacturing Practices.
Biocon’s Malaysia facility is Asia’s largest integrated insulins facility and manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices.
Biocon and Mylan’s Biosimilar Insulin Glargine Semglee® has previously received Regulatory approval from EMA in March 2018 and has been launched in key European markets by its partner Mylan since Nov 2018.