Clearwater, Florida- June 3, 2018 – CoreRx, Inc. announces that its client Bionpharma Inc. has received FDA approval for a generic version of Banzel® (Rufinamide) Oral Suspension, 40mg/mL. Rufinamide Oral Suspension is a second in a series of products developed and manufactured by CoreRx to be approved for Bionpharma. Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS). Bionpharma plans on launching Rufinamide Suspension upon satisfaction of certain legal and regulatory requirements.
On October 22, 2019, Bionpharma successfully launched Clobazam Suspension (Onfi®), the first US FDA approved product to be developed and commercially manufactured by CoreRx.
Todd R. Daviau, President and CEO at CoreRx added, “This launch represents a significant opportunity to establish CoreRx as a recognized commercial-scale manufacturing facility. The company’s expanded facilities and capabilities has been tested in both the development as well as commercialization phases.”
Bill Winter, EVP-Sales and Distribution added, “Rufinamide Suspension is a good addition to the growing portfolio of Bionpharma and the company’s endeavor to provide high quality, affordable generics to the US healthcare system.”
According to IQVIA™, U.S market annual sales for the 12 months ending December 2018 for Rufinamide Oral Suspension, 40mg/mL is estimated to be approximately $100 Million
About CoreRx, Inc.
CoreRx, a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical – niche commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi-solid dosage forms.
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