Stelis Biopharmas flagship DP facility receives EIR from USFDA

3 Sep 2022 , 01:31 AM

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 US 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