CoreRx, Inc. announces that its client Bionpharma has received FDA approval for a generic version of ONFI® (Clobazam)

CoreRx East

Clearwater, Florida- November 4, 2018 – CoreRx, Inc. announces that its client Bionpharma has received FDA approval for a generic version of ONFI® (Clobazam) Oral Suspension, 2.5mg/mL.  Clobazam Oral Suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.  CoreRx developed the formulation and will be the commercial manufacturer for this product.  This is the first commercial product at CoreRx’s facilities. Initial launch supplies for this product having already been produced.

Todd R. Daviau, President, and CEO at CoreRx added, “The launch of this product illustrates the transition of CoreRx from a clinical-stage producer, to now also being a commercial-scale CDMO. The Company has expanded its facilities and capabilities to reliably produce commercial quantities.  We believe this product approval validates the trust our clients have placed in our ability to take their compounds from development to commercialization”.

Bill Winter, EVP-Sales and Distribution added, “Clobazam is Bionpharma’s first launch on the day of expiry of exclusivity. Clobazam Suspension is developed and manufactured at CoreRx. The product launch is a testimony of their capability to execute commercial projects from start to finish in a timely manner. Clobazam 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 August 2018 for Clobazam Oral Suspension, 2.5mg/mL is estimated to be approximately $255 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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For further information, please contact:
CoreRx – Chief Business Officer, Mark DaFonseca or 727-259-6950