Strides Pharma's biologics arm receives EU-GMP accreditation for two manufacturing facilities

16 Jun 2022 , 09:37 AM

Stride Pharma Science Limited announced that its biologics arm Stelis Biopharma Limited had received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary. The company has received the said accreditation for two of its manufacturing facilities.

Commenting on the update, Arun Kumar, Founder, said, “The approval from EU-GMP is a significant stepping stone in our journey to build a global biologics CDMO platform that provides end-to-end solutions across the modalities. We have designed our facilities to meet global regulatory standards, and as the other global inspections also come through, we would have all the necessary approvals to serve the global players.

The last few quarters for our CDMO business have been enthusiastic as the company concluded various major contracts. These contracts contributed new service revenues to our business and increased our commercial sales value above $85 million in the peak year. The Global Biologics CDMO space remains thrilling, and we are confident that we will deliver better financial outcomes for Stelis as we progress.”

Stelis’ flagship facility (Unit 2, Bengaluru, India) is an integrated state-of-the-art manufacturing setup. This facility leverages microbial and mammalian platforms for the development and commercialization of biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilized vials.

Stelis’s small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) supports small-scale commercial and cGMP clinical trial material generation along with initial technology transfer activities across multiple modalities.

Strides Pharma is currently trading at Rs323 down by Rs3.1 or 0.95% from its previous closing of Rs326.10 on the BSE. The scrip opened at Rs331.50 and has touched intraday high and low of Rs332.70 and Rs322.20 respectively.