Strides Pharmas biologics arm gets US FDA nod for drug product capabilities

1 Sep 2022 , 10:51 AM

This outcome for the drug products facility comes after the U.S. Food and Drug Administration (US FDA) 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 automated drug products lines integrated with isolators to convert drug substances 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. Stelis Biopharma is an emerging biopharmaceutical contract development and manufacturing organization (CDMO) and the biologics arm of Strides Pharma Science. 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 pre commercial 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.? Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It mainly operates in the regulated markets and has an in Africa for Africa strategy and an institutional business to service donor-funded markets. The company focuses on difficult to manufacture products sold in over 100 countries. The company reported a consolidated net loss of Rs 135.89 crore in the quarter ended June 2022 as against net loss of Rs 205.20 crore during the previous quarter ended June 2021. Sales rose 36.56% to Rs 940.07 crore in Q1 FY23 over Q1 FY22. The scrip rose 0.82% to currently trade at Rs 333.60 on the BSE. Powered by Capital Market – Live News