Biocon Receives EU’s GMP Certification for its Semglee (biosimilar, Insulin Glargine) Manufacturing Facility in Malaysia

Biocon Receives EU’s GMP Certification for its Semglee (biosimilar, Insulin Glargine) Manufacturing Facility in Malaysia

Shots:

  • Biocon has received EMA’s certificate of GMP compliance from European inspection authority, Health Products Regulatory Authority (Ireland) and expand its capacities multi-fold with the new large-scale devices facility to meet the need of patients with diabetes in EU
  • The manufacturing facility at Malaysia was inspected in May’2019 and is Asia’s largest integrated insulins facility and manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices including recombinant human Insulin (rh-Insulin) and Insulin Glargine
  • Biocon & Mylan’s Semglee, a biosimilar to Sanofi’s Lantus is an approved therapy in 60+ countries including its EMA’s approval in Mar’2018 and is available in key EU markets by Mylan since Nov’2018

Click here to­ read full press release/ article | Ref: Biocon | Image: Different Strokes