J. B. Chemicals & Pharmaceuticals Ltd. (JBCPL) has filed its first Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (U.S. FDA). The filing was made by the Company's US - JV Company, NeoJB LLC(NeoJB) on behalf of J.B. Chemicals & Pharmaceuticals Ltd. Upon approval of the ANDA and expiration of the patent for the indicated drug, JBCPL will manufacture the product and NeoJB will market it in the United States.Revenue from the sale of the indicated drug is likely to commence during 2004.
"When we decided to first partner with Spectrum Pharmaceuticals Inc, (formerly NeoTherapeutics Inc) we did so with confidence in their ability to aggressively implement our common vision to pursue the growing generic drug business in the United States," said J.B. Mody, Chairman of JBCPL. "This ANDA filing marks the first of many we hope to participate in with Spectrum through our NeoJB venture. We remain confident in our ability to produce high quality generic drugs at competitive prices, and in Spectrum's ability to pursue regulatory approvals and ultimately oversee the marketing of these drugs."
Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum stated, "While we remain committed to and focused on the clinical development of novel oncology products, the generic business represents a tremendous opportunity given our partners in India.Additionally, we believe that the growth potential in the generic business is enormous, and the low cost, high quality manufacturing capabilities of our Indian partners' provides us with a competitive advantage. Assuming approval of this first ANDA by the FDA, we hope to begin realizing revenues from this product next year".
In April 2002, JBCPL and Spectrum formed NeoJB LLC to enable Spectrum to benefit from JBCPL's high quality, lower cost drug manufacturing capabilities through the sale of JBCPL's generic drugs in the United States.JBCPL will benefit from Spectrum's skills in managing the regulatory and marketing functions in the United States.NeoJB LLC is an 80:20 JV of Spectrum and a subsidiary of JBCPL respectively. Spectrum is actively working to develop, seek approval for generic drugs in the U.S. market through NeoJB. These generic drugs will be manufactured by JBCPL and supplied to the said joint venture - NeoJB, for sale in the U.S. market.
JBCPL's products are marketed and well accepted in over 50 countries and it has number of manufacturing facilities producing a diverse range of high quality bulk drugs for domestic use and as a supplier to international markets.They also sell pharmaceutical specialties, radio-diagnostics, herbal remedies and generic drugs, active pharmaceutical ingredients and its intermediates.JBCPL produces and markets a family of herbal products under the "Doktor Mom" label.