Stelis Biopharma CDMO partner gets USFDA nod for key ANDA

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

The filing for the product was done from Stelis Biopharma's facility in Bangalore. Stelis will manufacture and commercially supply the product to its CDMO partner from its facility in Bangalore, India. The 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 Establishment Inspection Report (EIR) from USFDAfor Drug Products (DP).

Arun Kumar, the Founder, commented on the development, saying, " 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 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"

Read also: Strides Pharma Science Singapore arm secures USFDA okay for Potassium Chloride Oral Solution