Stelis Biopharma, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science today announced that it received the Establishment Inspection Report (EIR) from U.S. Food and Drug Administration (USFDA
or agency) for the Drug Products (DP) facility inspection that was completed at its flagship manufacturing site (Unit 2) at Bengaluru, India.
This outcome for the DP facility comes after the USFDA on-site Pre-Approval Inspection (PAI) at Stelis flagship manufacturing facility for several product submissions by the partners to the agency. The Unit 2 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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