Bengaluru, India - Stelis Biopharma Limited (Stelis or Company), an emerging biopharmaceutical and vaccine Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited (Strides, BSE: 532531 NSE: STAR), announced that it had 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.
Commenting on the update, Arun Kumar, Founder, said, 'The approval from EU-GMP is a significant first step in our journey to build a global biologics CDMO platform that offers end-to-end solutions across the modalities. Our facilities are designed to meet global regulatory standards, and as the other global inspections also come through, we would have all the necessary approvals to cater to global players. The last few quarters for our CDMO business have been eventful as we concluded various major contracts. These contracts have added new service revenues to our business and resulted in a commercial sales value of over $85 million in the peak year. The Global Biologics CDMO space remains exciting, and we are confident of delivering better financial outcomes for Stelis as we progress.'
Stelis' flagship facility (Unit 2, Bengaluru, India) is an integrated state-of-the-art manufacturing setup that leverages microbial and mammalian platforms for developing and commercializing biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilized vials. The facility has the most modern equipment setup, including the use of industryleading technologies like single-use bags and isolator-based manufacturing, offering significant operational flexibility.
Stelis's small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) is designed to support smallscale commercial and cGMP clinical trial material generation and initial technology transfer activities across multiple modalities. The facility is equipped with high-throughput instrumentation that offers different analytical developmental and characterization services for a wide range of biopharmaceutical products conforming to global regulatory standards throughout their lifecycle.
As an emerging CDMO partner for the global biopharmaceutical industry, Stelis is committed to offering end-to-end solutions for developing and commercializing biologics, biosimilars, and vaccines. The company has recently entered into marquee international partnerships and gained comprehensive experience in manufacturing biologics for diabetes, osteoporosis, and other therapeutic categories using mammalian and microbial systems from the pre-clinical stage through commercialization. With over US$ 300 million in investments, Stelis has built a robust CDMO platform that offers one of APAC's largest drug substance capacities with over 48,000L across various modalities and drug product capacities exceeding 400 million units per annum.
About Stelis
Stelis Biopharma Limited (Stelis) is an emerging global biopharmaceutical CDMO with a complete and integrated end-to-end offering. It is equipped with world-class Process Development (PD) and manufacturing infrastructure for both drug substances (mammalian and microbial-based therapeutic proteins and other emerging modalities) and drug products (lyophilized vials, liquid vials, pre-filled syringes, cartridges, and devices). Stelis offers the complete spectrum of services, from cell line tech transfer to clinical and commercial manufacturing, with in-house capability to convert drug substances to stable formulations and fill and finish in all formats. Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space and over 800 highly talented professionals. Its facilities are highly automated to increase accuracy, efficiency, and speed at every process stage. Additional details are available at www.stelis.com
About Strides
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an 'in Africa for Africa' strategy and an institutional business to service donor-funded markets. The Company's global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on 'difficult to manufacture' products sold in over 100 countries. Additional information is available at the Company's website at www.strides.com.
Contact:
Stelis
E: ankit@stelis.com
STRIDES PHARMA SCIENCE LIMITED 
