Strides Pharma Science Ltd's subsidiary Stelis Biopharma Ltd has received establishment inspection report from the US Food and Drug Administration for the drug-device combination products to be commercialised at facility in Bengaluru, via a press release.
Previously, the regulator issued an establishment inspection report to Stelis in September, based on an on-site pre-approval inspection and, consequently, the first product approval for one of its key customers in December.
Stelis is an emerging biopharmaceutical contract development and manufacturing organisation (CDMO) and the biologics arm of Strides Pharma Science.
This abbreviated quality system inspection technique 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.
Arun Kumar, founder of the company, commented on the development, saying, "We are delighted to have closed our successful inspection within 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."
Shares of Strides Pharma were trading 0.2% higher on the NSE at 333.55 rupees at 12:00 IST.
