Strides Pharma Arm Gets EU-GMP Certification

Strides Pharma Science announced on Thursday that its subsidiary has obtained EU-GMP certification for its two manufacturing sites from the National Institute of Health and Nutrition in Hungary.

Stelis Biopharma, an emerging Contract Development and Manufacturing Organisation (CDMO) for bio pharmacy and vaccines and Strides Pharma's biopharmaceutical division, has obtained EU Good Manufacturing Practice (EU-GMP) certification for its two manufacturing facilities.

Stelis' flagship facility (Unit 2, Bangalore, India) is an integrated manufacturing facility that leverages microbial and mammalian platforms to develop and commercialize biologics and biosimilars in multiple locations. Finished formats, including cartridges, equipment, prefilled syringes, liquid, and lyophilized vials.

In addition, the small-scale cGMP manufacturing facility (Unit 1, Bangalore, India) is designed to support the creation of small-scale commercial and cGMP clinical trial materials and delivery operations. 

With over $300 million in investments, Stelis has built a robust CDMO platform that offers one of the largest drug capacities in APAC with over 48,000 liters in multiple modalities and drug product capacity in excess of 400 million units per year.