Strides Pharma's arm receives EIR from USFDA for Drug Products facility in Bengaluru
1st Sep 2022

Strides Pharma Science’s biologics arm and an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) -- Stelis Biopharma has received the Establishment Inspection Report (EIR) from U.S. Food and Drug Administration (USFDA) 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.

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.