Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited is pleased to announce that its CDMO partner has received approval for a key ANDA from the United States Food & Drug Administration (USFDA).

The filing for the product was done from Stelis Biopharma’s flagship facility in Bangalore.

Stelis will manufacture and commercially supply the product to its CDMO partner from its flagship facility in Bangalore, India. The flagship facility has high-end automated DP lines integrated with isolators to convert drug substances (DS) into stable formulations and fill finish within the same facility in all injectable formats, including cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials. The facility had recently received an Establishment Inspection Report (EIR) from USFDA for Drug Products (DP).

Commenting on the development, Arun Kumar, Founder said, "The Stelis leadership team is pleased with the key ANDA approval received by our CDMO partner today. The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore. We are excited about the upcoming launches by our partners from the facility including several approvals expected in the near term.”

Stelis offers a complete spectrum of services, from cell line tech transfer to clinical and commercial manufacturing, with in-house capability to convert drug substances to stable formulations and fill and finish in all formats. Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space and over 800 highly talented professionals. Its facilities are highly automated to increase accuracy, efficiency, and speed at every process stage.