Strides Pharma Science said that its biologics arm, Stelis Biopharma, has received establishment inspection report (EIR) from U.S. Food and Drug Administration (USFDA) for the drug-device combination to be commercialized from Bengaluru facility.
This abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the USFDA for the drug-device combination products that are to be manufactured/ commercialized at the site for the partner products by Stelis.Previously, the USFDA issued an EIR to Stelis in September 2022 based on on-site Pre-Approval Inspection (PAI) and, consequently, the first product approval for one of its key customers in December 2022.
As a fully integrated biologics Contract Development and Manufacturing Organization (CDMO), Stelis can offer a complete spectrum of services from its facilities. Besides the DP capabilities in cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials, the facility has proven technical expertise and capabilities to manufacture drug substance (DS) across microbial, mammalian, and various other technology platforms with world-class cGMP, regulatory, and quality systems. Stelis continues to build its clientele with global partnerships and onboarding of new programs on the drug substance and drug product side
Arun Kumar, the founder, commented on the development said, Several of our customers' key fillings will now progress towards nearer-term approvals leading to an uptick in our CDMO revenues. We remain excited about the strategic progress that the Company has made so far and are confident of delivering better business outcomes.
Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.
The company reported consolidated net profit of Rs 22.83 crore in Q2 FY23 as against net loss of Rs 162.56 crore in Q2 FY22. Net sales rose 24.3% YoY to Rs 897.10 crore in Q2 FY23.
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