1.        Background of the Project

Degussa Rexim (Nanning) Pharmaceutical Co., Ltd. is a bio-pharmaceutical manufacturing enterprise located in Nanning City, Guangxi Province, P.R.China. It is a subsidiary wholly owned by Degussa Group (located in Germany), which is one of the World抯 Top-500 Enterprises. The predecessor of Degussa Rexim (Nanning) Pharmaceutical Co., Ltd. is a Sino-French joint venture ----- Nanning Only-Time Rexim Pharmaceutical Co., Ltd.  

Nanning Only-Time Rexim Pharmaceutical Co., Ltd. was established in April, 2001, 96.25% of the company抯 equity was held by Degussa Group. Since the establishment, Degussa Group had invested 36 million USD to this company, mainly used for building a production line (incl. construction of production plant & refining unit and installation of equipment & auxiliary facilities) of Pharmaceutical Infusion Grade L-Methionine with 400T/Y capacity. The qualification of construction & installation of the production line had been completed in Oct. 2004 and, the trial production of L-Methionine has started since Nov. 2004. 

2. Usage of L-Methionine 

At present, Methionine (incl. L-Methionine, DL-Methionine, D-Methionine) in various grades is widely used in the fields of animal feed additives, food additives, fine chemicals and pharmaceuticals.

A human protein commonly consists of 20 kinds of L-amino acids. The structure and function of one protein different from those of another, is determined by different linking patterns or sequences of the 20 different amino acids. L-Methionine is one of the 20 amino acids; even more important, L-Methionine is one of the 8 Essential Amino Acids to human body (Essential Amino Acids cannot be synthesized in human body and must be supplied by food; other 12 amino acids aren抰 Essential Amino Acids.). If a human body is lack of L-Methionine, the liver, kidney and/or other organs of it will be in malfunction, therefore, L-Methionine is essential in protecting the normal functions of liver and kidney; besides, L-Methionine can promote the revitalizing of skin to softness and smoothness and promote the growing of hair and fingernail, and, it is also effective in detoxification and improving the ability of muscle and/or skeleton to perform activities. L-Methionine has special structure, it is the only amino acid containing sulfur atom in the 8 Essential Amino Acids and is the 揵ackbone?for the biosynthesis of a protein and hence, it has very extensive usage.

As an active pharmaceutical ingredient, our Pharmaceutical Infusion Grade L-Methionine is mainly used for preparing compound amino acid injections (18AA, 14AA, 11AA, etc.). With the improvement of people's living standard and the increasing demand for good health, the market demand for L-Methionine must be increased constantly. 

3.      Matured Process Technology

Our parent company Degussa Group is responsible for transferring the matured process technology (with international technological patent right) to our company as well as designing and building the L-Methionine production line. In addition, Degussa Group is in charge of the supply of Feed Grade DL-Methionine which is the starting material for manufacturing Pharmaceutical Infusion Grade L-Methionine, and, responsible for introducing the rich experience in L-Methionine manufacture and quality control accumulated by Degussa employees all around the world for more than 20 years to our company.  

For manufacturing L-Methionine, we split the acetylated DL-Methionine by a kind of biocatalyst ---- Acylase. The solution which comes from enzymatic splitting with the mixture of L-Methionine, N-Acetyl-D-Methionine Sodium Salt and Sodium Acetate, is then treated by ion exchange resins to obtain another solution containing rich L-Methionine fraction. After concentration under vacuum, the solution containing rich L-Methionine fraction goes through following purification steps of active charcoal discoloration, press filtration, ultra-filtration, crystallization, centrifugation, methanol digestion (crystals), pure centrifugation and vacuum drying to obtain high-purity finished L-Methionine.    

Thanks to the high-activity biocatalyst and advanced refining technology, the finished L-Methionine manufactured during trial production period has shown high quality in general, with main characteristics of low impurities, low pyrogen, high transmittance and satisfied color.   

Our Pharmaceutical Infusion Grade L-Methionine had got the Drug Registration License issued by Chinese State Food and Drug Administration in Aug. 2005；in addition, its DMF dossier has been submitted to Swedish drug regulatory authorities MPA (Medical Products Agency), German drug regulatory authorities BfArM (Bundesinstitut f黵 Arzneimittel und Medizinprodukte) and American drug regulatory authorities FDA (Food and Drug Administration) and its CEP dossier has been submitted to European drug regulatory authorities EDQM (European Directorate for the Quality of Medicines) for examination. 

Compiled by: Elizabeth Huang

Sep. 6, 2005