Stelis Biopharma’s CDMO partner to get USFDA approval for a key ANDA

Stelis Biopharma, Strides Pharma Science’s biologics division, announced that its CDMO partner has received approval from the US Food and Drug Administration for a key ANDA (USFDA). The product was filed from Stelis Biopharma’s flagship facility in Bangalore. Stelis’ flagship facility in Bangalore, India, will manufacture and commercially supply the product to its CDMO partner.

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

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