Stelis Biopharma, the biologics arm of Strides Pharma Science, has received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary for two of its manufacturing facilities.
Stelis’ flagship facility (Unit 2, Bengaluru, India) is an integrated state-of-the-art manufacturing setup that leverages microbial and mammalian platforms for developing and commercializing biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilized vials. The facility has the most modern equipment setup, including the use of industry-leading technologies like single-use bags and isolator-based manufacturing, offering significant operational flexibility.
Stelis’ small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) is designed to support small-scale commercial and cGMP clinical trial material generation and initial technology transfer activities across multiple modalities. The facility is equipped with high-throughput instrumentation that offers different analytical developmental and characterization services for a wide range of biopharmaceutical products conforming to global regulatory standards throughout their lifecycle.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
