Stelis Biopharma's CDMO partner receives USFDA approval for a key ANDA

Stelis Biopharma, the biologics arm of Strides Pharma Science announced 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 Establishment Inspection Report (EIR) from USFDA for Drug Products (DP).

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