Chemwerth Scales-up DAVANAT to 100 Kilos per Batch
Posted on 2007-02-21 10:35:00
Pro-Pharmaceuticals, Inc. a developer of novel carbohydrate compounds, today announced it is collaborating with Chemwerth, Inc. to scale-up production of its lead drug candidate, DAVANAT® to 100 kilograms for initial marketing needs. DAVANAT® is a carbohydrate polymer composed of mannose and galactose (galactomannan). Chemwerth, Inc. is an Active Pharmaceutical Ingredient (API) development and supply company specializing in generic drugs that include oral, injectable, topical and veterinary products.
"Our goal is to provide Pro-Pharmaceuticals with a clinical-grade quality product that meets the FDA's requirements for an NDA submission," said Peter Werth, Chief Executive Officer, Chemwerth, Inc. "We believe in Pro-Pharmaceuticals' DAVANAT® product and look forward to helping them gain marketing approval."
Chemwerth offers one of the broadest lines of injectable grade oncology products in the U.S., including, Amifostine, Carboplatin USP, Cisplatin USP, Doxorubicin HCl USP, Epirubicin HCl EP, Etoposide USP, Fludarabine Phosphate, Gemcitabine HCl USP, Ifosfamide USP, Irinotecan HCl 3H2O, Mitoxantrone HCl USP/PhEur and Thiotepa USP.
The Company is using DAVANAT® to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company's proprietary drug target delivery compound through Section 505(b)(2). The FDA has approved galactomannans for oral and topical applications. The Company is seeking approval for co-administration of DAVANAT® (a galactomannan) with 5-Fluorouracil (5-FU) for intravenous injection in the treatment of cancer. FDA-approved, 5-FU is one of the world's most widely used chemotherapeutic drugs.
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