Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes

Stelis Biopharma Limited (Stelis), an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited, has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) specific to Drug-Device Combination Products to be commercialized at Stelis’ flagship facility in Bengaluru, India.

This Abbreviated Quality System Inspection Technique (QSIT) drug preapproval 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.

Commenting on the development, Arun Kumar, Founder said, "We are delighted to have closed our successful inspection within a few months by the USFDA covering a larger scope to include Drug-Device combination products where Stelis is emerging as a global leader with significant capacities established and customers onboarded. 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.”