The pharmaceutical firm Strides Pharma Science announced on Thursday that two of its manufacturing sites in Hungary have been certified by the National Institute of Pharmacy and Nutrition as meeting EU-GMP standards.
Two manufacturing plants of Strides Pharma’s subsidiaries, Stelis Biopharma, a growing vaccine and biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics division have received EU-GMP certificates.
Reacting to the news, the founder of the company Arun Kumar said, “The EU-GMP license is a major stride in our mission to develop an international biologics CDMO podium that delivers end-to-end answers for all treatments.”
The facilities are built to international regulations and will therefore be able to serve worldwide customers. Because the other global assessments are also coming through, the firm will have all of the required permissions to service global competitors.
“Our CDMO business has been eventful in recent quarters as we completed several major contracts. These deals have generated new service incomes, resulting in market sales worth over $85 million during the pinnacle year,” Kumar added.
Stelis’ main research and manufacturing facility (Unit 2, Bengaluru, India) is a biotechnology production and marketing system that applies mammalian and microbial platforms to create and market biologicals as well as biosimilars in a variety of fill-finish forms, including lyophilized vials, liquid, pre-filled syringes, devices, and cartridges.
Furthermore, its diminutive cGMP production plant (Unit 1, Bengaluru, India) is built to sustain miniature cGMP and commercial medical test material production and first technology transfer for several treatments.
Stelis has developed a solid CDMO stage with the largest drug substance capabilities (over 48,000 litres cut through myriads of treatments and drug development capabilities exceeding four hundred million units per year), by leveraging $300 million in funding.