Strides Pharma arm gets EIR from USFDA for Bengaluru facility

Bengaluru: Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited, 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.

Arun Kumar, the Founder, commented on the development, saying, "I am very pleased with the USFDA nod for DP capabilities at our flagship facility, a second major win after receiving the EU-GMP approval in June 2022. While these two outcomes validate our GMP systems and Global Quality fabric, it fast-tracks our ability to close out on the impending manufacturing services agreements for the precommercial revenues. The EIR from USFDA now also paves the way for the commercial services revenue from the site in the next two quarters after our partners receive respective product approvals. We have had an exciting year so far, and we continue to deliver even better financial outcomes as we accelerate and build on the opportunities in the Global CDMO landscape."

Besides the DP capabilities, the Unit 2 facility has proven technical expertise and capabilities to manufacture DS across microbial, mammalian, and various other technology platforms with cGMP, regulatory, and quality systems. 

Earlier in June 2022, the facility received European Union Good Manufacturing Practice (EU-GMP) approval. 

Read also: Strides Pharma Kenya based arm bags WHO certification to produce antimalarial drug