Stelis Biopharma's CDMO partner receives approval for a key ANDA 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 its CDMO partner has received approval for a key ANDA from the United States Food & Drug Administration (USFDA). The filing for the product was done from Stelis Biopharma's flagship facility in Bangalore.

Stelis will manufacture and commercially supply the product to its CDMO partner from its flagship facility in Bangalore, India. The Flagship facility has high-end automated DP lines integrated with isolators to convert drug substances (DS) into stable formulations and fill finish within the same facility in all injectable formats, including cartridges, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials. The Facility had recently received Establishment Inspection Report (EIR) from USFDA for Drug Products (DP).

Arun Kumar, the Founder, commented on the development, saying, " The Stelis leadership team is pleased with the key ANDA approval received by our CDMO partner today. The current approval is first of the many fillings made by company's CDMO partners from the flagship facility in Bangalore. We are excited about the upcoming launches by our partners from the facility including several approvals expected in the near term".

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 349.05 as compared to the previous close of Rs. 353.80. The total number of shares traded during the day was 20206 in over 1354 trades.

The stock hit an intraday high of Rs. 357.90 and intraday low of 348.00. The net turnover during the day was Rs. 7102618.00.

Source : Equity Bulls

Keywords

StridesPharmaScience INE939A01011 StelisBiopharma CDMOPartner ANDA USFDA