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Stelis Biopharma's flagship facility receives EIR from the USFDA

Posted On : 2023-01-18 11:22:41( TIMEZONE : IST )

Stelis Biopharma's flagship facility receives EIR from the USFDA

Stelis Biopharma Limited (Stelis or Company), an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited (Strides, BSE: 532531 NSE: STAR), has announced that it has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA or FDA or Agency) 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.

Arun Kumar, the Founder, 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. 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."

As a fully integrated biologics CDMO, Stelis can offer a complete spectrum of services from its facilities. Besides the DP capabilities in cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials, the facility 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 Company's integrated capabilities offer significant operational flexibility, greater efficiency, and varied scope within the same premises.

Stelis continues to build its clientele with global partnerships and onboarding of new programs on the drug substance and drug product side. It remains a strong biologics CDMO player given its comprehensive capabilities, high-quality systems, large drug substance (DS) scale across modalities, and significant fill-finish capacity.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 332.90 as compared to the previous close of Rs. 334.35. The total number of shares traded during the day was 7113 in over 871 trades.

The stock hit an intraday high of Rs. 335.30 and intraday low of 331.10. The net turnover during the day was Rs. 2366425.00.

Source : Equity Bulls


StridesPharmaScience INE939A01011 StelisBiopharma EIR USFDA Bengaluru