Strides Pharma Science’s arm’s CDMO partner gets nod for key ANDA from USFDA

28 Dec 2022 Evaluate

Strides Pharma Science’s biologics arm -- Stelis Biopharma’s Contract Development and Manufacturing Organization (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).

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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