Jan 18, 2023

The US FDA’s EIR is received for the drug-device combination to be commercialised from the Stelis Pharma's flagship facility in Bengaluru, India January 18, 2023 / 11:20 AM IST The FDA had in September 2022 issued Stelis Pharma an EIR based on on-site Pre-Approval Inspection (PAI), and then in December 2022, the first product approval for one of its key customers (Image Source: Shutterstock) Trade × Stelis Biopharma has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA), after the successful closure of its inspection specific to Drug-Device Combination Products to be commercialised at its flagship Bengaluru facility, it told the bourses on January 18. At the time of writing, Stelis Biopharma’s parent company, Strides Pharma Science was quoting at Rs 333.05, up Rs 0.15, or 0.05 percent. Founder Arun Kumar said they are “delighted” with the successful inspection, adding that they have “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,” Kumar said. Stelis, which is a fully integrated biopharmaceutical contract development and manufacturing organisation (CDMO), had the US FDA conduct an Abbreviated Quality System Inspection Technique (QSIT) drug preapproval on-site inspection. Related stories