Bengaluru: Stelis Biopharma Limited, an emerging
biopharmaceutical and vaccine Contract Development and Manufacturing Organization (CDMO) and
the biologics arm of Strides Pharma Science Limited, today
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. 

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

“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 stated.

Stelis Biopharma Limited is equipped with 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).

Read also: Strides Pharma biotech division gets CDSCO nod to manufacture, export Sputnik Light

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