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JB Chem files 1st ANDA, US FDA
January 16, 2003 11:34 IST
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.

The filing was made by the company's US joint venture company, NeoJB LIC 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 the drug in the US.

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."

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 joint ventures of Spectrum and a subsidiary of JBCPL respectively. Spectrum is actively working to develop, seek approval for generic drugs in the US market through NeoJB.

These generic drugs will be manufactured by JBCPL and supplied to the said joint venture NeoJB for sale in the US market.

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