HILLSIDE, N.J., June 1 /PRNewswire-FirstCall/ -- Integrated BioPharma, Inc. announced that its subsidiary, Paxis Pharmaceuticals, Inc., expects to submit a Drug Master File (DMF) for its paclitaxel API to the FDA on June 7th and will ship its first API paclitaxel to fill existing orders in June. Paxis is producing paclitaxel Active Pharmaceutical Ingredient (API) under current Good Manufacturing Practices (cGMP). The plant, which is currently scaled for production at the rate of 50 kgs of paclitaxel API per year, is expected to scale up to a capacity of more than 200 kgs per year during the next six months and ultimately to its maximum designed capacity of 400 kgs of paclitaxel per year.
"We are pleased with the ongoing progress at our subsidiary, Paxis Pharmaceuticals," states E. Gerald Kay, CEO of Integrated BioPharma. "Paxis is on schedule to ship existing orders of our first API product, Paclitaxel, and is ramping up its production levels to meet future demand. In addition, Paxis is now examining with existing and potential customers complete production of the active pharmaceutical ingredient for their new Paclitaxel based compounds."
Paxis' first product is the generic active pharmaceutical ingredient (API) paclitaxel. Paxis' mission is to be the premier supplier of paclitaxel and other naturally derived taxanes and taxane-based compounds to the pharmaceutical and biotech industry. Further information is available at http://www.paxispharma.com/ .
INB serves the pharmaceutical, biotech and nutraceutical industries. Through several wholly owned subsidiaries, INB develops, manufactures and distributes more than 130 products worldwide. Its subsidiary, Paxis Pharmaceuticals, Inc., develops and operates a state-of-the art GMP facility for the production and sale of paclitaxel and related drugs. Through its biotech subsidiary, NuCycle Therapy, Inc., INB is developing human therapeutics and preventive cancer compounds in transgenic plants. Further information is available at http://www.ibiopharma.com/.
Statements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects, and internal issues in the sponsoring client. Further information on potential risk factors that could affect the company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.
Integrated BioPharma, Inc.