The pharma company said its biologics arm, Stelis Biopharma, received the EU-GMP compliance certificate for two of its manufacturing facilities.
Stelis received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary for both for the flagship facility and small-scale commercial & clinical batch manufacturing facility.Stelis' flagship facility (Unit 2, Bengaluru, India) offers integrated microbial and mammalian platforms for biologics development and commercial manufacturing, along with the capability to convert drug substance to stable formulations and fill and finish in all injectable formats.
Stelis' small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) is suited for early-stage clinical trial material generation and commercial manufacturing, including initial technology transfer activities across multiple modalities.
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 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).
Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It 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 focuses on "difficult to manufacture" products sold in over 100 countries.
The drug maker reported a 36.6% decline in consolidated net profit to Rs 29.22 crore on a 4.7% fall in net revenue from operations to Rs 866.02 crore in Q4 FY22 over Q4 FY21.
Shares of Strides Pharma Science jumped 5.53% to Rs 326.10 on Wednesday.
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