Stelis Biopharma Limited, the biologics arm of Strides Pharma Science Limited, announced that it had received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for the Drug Products (DP) facility 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.
As a fully integrated biologics CDMO, Stelis can offer a complete spectrum of services from its Unit 2 facility. Besides the DP capabilities, the facility has proven technical expertise and capabilities to manufacture DS across microbial, mammalian, and various other technology platforms with world-class cGMP, regulatory, and quality systems. The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise. Earlier in June 2022, the facility received European Union Good Manufacturing Practice (EU-GMP) approval.
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