Strides Pharma Science said that its biologics arm, Stelis Biopharma, has received an establishment inspection report (EIR) from US Food and Drug Administration (US FDA) for the drug-device combination to be commercialised from the Bengaluru facility.

The abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the US FDA for the drug-device combination products that are to be manufactured/ commercialised at the site for the partner products by Stelis.

Previously, the US FDA 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 programmes on the drug substance and drug product side.