Strides Pharma Science’s biologics arm -- Stelis Biopharma 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.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
