Strides Pharma gains as CDMO partner of arm gets USFDA nod for key ANDA

Strides Pharma Science rose 1.86% to Rs 355.60 after the company's biologics arm, Stelis Biopharma announced that its Contract Development and Manufacturing Organization (CDMO) partner has received approval for a key ANDA from the US drug regulator.

The abbreviated new drug application (ANDA) 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 facility in Bangalore, India.

The facility has high-end automated drug product lines integrated with isolators to convert drug substances 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 United States Food & Drug Administration (USFDA) for drug products.

Arun Kumar, the founder of Stelis commented, "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.

Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It mainly operates in the regulated markets and has an "in Africa for Africa" strategy and an institutional business to service donor-funded markets.

The company reported a consolidated net profit of Rs 22.83 crore in Q2 FY23 against a net loss of Rs 162.56 crore posted in Q2 FY22. Net sales jumped 24.3% year on year to Rs 897.10 crore in Q2 FY23.

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