Stelis Biopharma receives EIR from the US FDA for Drug-Device Combination Products

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)

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26 Aug, 2025 12:21

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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.

Prior to this, the FDA had in September 2022 issued Stelis 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.

The company

Stelis offers a spectrum of services from its facilities – such as DP capabilities in cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials, and has proven technical expertise and capabilities to manufacture DS across microbial, mammalian, and various other technology platforms with world-class cGMP, regulatory, and quality systems, the release added.

Stelis has three state-of-the-art and highly automated facilities, with approximately 85,000 square meters of PD and manufacturing space and over 800 professionals, as per the release.

Its parent Strides' global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York), focussing on "difficult to manufacture" products sold in over 100 countries, it said.