Strides Pharma arm gets EU-GMP certification for 2 facilities from Hungary

Strides Pharma Science on Thursday said its subsidiary has received EU-GMP certification for two of its manufacturing facilities from Hungary's National Institute of Pharmacy and Nutrition.

Stelis Biopharma, an emerging biopharmaceutical and vaccine Contract Development and Manufacturing Organisation (CDMO) and the biologics arm of Strides Pharma, has received the European Union Goods Manufacturing Practices (EU-GMP) certification for the two manufacturing plants.

"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," company founder Arun Kumar said in a statement.

The facilities are designed to meet global regulatory standards, and as the other global inspections also come through, the company would have all the necessary approvals to cater to global players, he added.

"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 USD 85 million in the peak year," Kumar stated.

Stelis' flagship facility (Unit 2, Bengaluru, India) is an integrated manufacturing set-up that leverages microbial and mammalian platforms for developing and commercialisng biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilized vials.

Besides, its 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.

With over USD 300 million in investments, Stelis has built a robust CDMO platform that offers one of APAC's largest drug substance capacities with over 48,000 litre across various modalities and drug product capacities exceeding 400 million units per annum.