Stelis Biopharma receives establishment inspection report from USFDA

Strides Pharma Science on Wednesday said its arm Stelis Biopharma has received an establishment inspection report (EIR) from the US health regulator specific to drug-device combination products to be commercialised at its flagship facility in Bengaluru. This follows the abbreviated quality system inspection technique drug pre-approval on-site inspection specifically conducted by the US Food and Drug Administration (USFDA) for the drug-device combination products that are to be manufactured and commercialised at the site for the partner products by Stelis, it said in a regulatory filing.

Stelis is an emerging biopharmaceutical contract development and manufacturing organisation (CDMO) and the biologics arm of Strides Pharma Science.

It had previously received an EIR from the USFDA 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, the filing added.


"Several of our customers' key fillings will now progress towards nearer-term approvals leading to an uptick in our CDMO revenues," Strides Pharma Science Founder Arun Kumar said.