Benda's Jiangling Plant Receives Production Approval

Benda Pharmaceutical, a China-based pharmaceutical company producing both Gendicine, the world's first commercialized gene therapy medicine for the treatment of cancer, and traditional Chinese and conventional medicines, announced its Jiangling plant has received approval from the State Food and Drug Administration to re-initiate production of its primary product line.

This was the last step necessary for Jiangling to be eligible for Good Manufacturing Practices certification, a standard required in China to produce pharmaceuticals or their ingredients. Jiangling will begin production immediately upon the receipt of its GMP certification.

Jiangling originally closed in July 2004 to complete renovations necessary to secure GMP certification. The GMP process has been unexpectedly drawn out due to the much-publicized restructuring of the SFDA.

Jiangling reopened and started to produce bulk chemical in August 2007 as producing and selling bulk chemical in China does not require GMP certification. Jiangling primary products, for which it has now received production approval, are active pharmaceutical ingredients. Jiangling is now eligible for GMP certification and will begin API production immediately upon certification receipt.

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