Strides Pharma Science said that its biologics arm Stelis Biopharma has secured an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) pertaining to the commercialization of drug-device combination products at its Bengaluru facility.

Stelis Biopharma is an Indian contract development and manufacturing organization (CDMO).

Strides Pharma Science said that the abbreviated quality system inspection technique (QSIT) drug preapproval on-site inspection was carried out specifically by the FDA for the drug-device combination products that are to be manufactured/ commercialized at the location by Stelis Biopharma for its partner products.

Last September, an EIR was issued by the FDA to Stelis Biopharma based on on-site pre-approval inspection (PAI), and, subsequently, the first product approval for one of its main customers in December 2022.

Arun Kumar — Strides Pharma Science Founder said: “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. 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.”

  Arun Kumar, Bengaluru, India, Karnataka, Stelis Biopharma, Strides Pharma Science, US Food and Drug Administration