Stelis Biopharma CDMO partner gets USFDA nod for key ANDA

Written by Ruchika Sharma Published On 2022-12-28T15:19:02+05:30 | Updated On 28 Dec 2022 3:27 PM IST

Stelis Biopharma CDMO partner gets USFDA nod for key ANDA

Bengaluru: Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited has announced that its CDMO partner has received approval for a key Abbreviated New Drug Application (ANDA) from the United States Food & Drug Administration (USFDA).

The filing for the product was done from Stelis Biopharma's 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 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 USFDAfor 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"

Stelis Biopharma Limited is an emerging global biopharmaceutical CDMO with a complete, integrated, end-to-end offering. It is equipped with Process Development (PD) and manufacturing infrastructure for both drug substances (mammalian and microbial-based therapeutic proteins and other emerging modalities) and drug products (lyophilized vials, liquid vials, pre-filled syringes, cartridges, and devices). Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space.

Read also: Strides Pharma biologics arm bags EU-GMP accreditation for 2 facilities

Stelis BiopharmaStrides Pharma ScienceUSFDA

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751