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.
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