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China surpasses developed countries in 7-ADCA production capacity

By Grace Zhang, Pharmaceutical Manufacturing News
Wednesday, 07 May 2008

Shandong Lunan Pharmaceutical Group has recently completed the construction of a new 3000-ton 7-ADCA facility, making it the world’s largest 7-ADCA producer. With the opening of the facility, China is expected to dominate the international cephalosporin market with the total production of 7-ADCA breaking the

4,000-ton mark this year, overtaking such longstanding market leaders as the US, Italy and the Netherlands.
Due to a variety of factors, the Chinese cephalosporin market developed at a very slow rate during the 1970s, when most of the APIs used to produce cephalosporin drugs were imported.

However, since Harbin Pharmaceutical Group built a facility producing cephalosporin APIs including 6-APA, 7-ACA and 7-ADCA with cephalosporin C semisynthetic technology imported from South Korea in the late 1980s, the market has been growing rapidly and at least one hundred pharmaceutical makers including North China Pharmaceutical
and Shandong Lukang Pharmaceutical have begun producing a variety of cephalosporins. In addition, Sichuan Changzheng Pharmaceutical in partnership with Sichuan Indusitrial Intitute of Antibiotics, established a 100-ton 7-ADCA joint venture facility. The annual production of 7-ADCA in China exceeded 1,000 tons in 2006.

Chinese cephalosporin makers have for many years failed to meet the demand of the pharmaceutical sector for 7-ADCA as a result of low production volume and high costs as well as immature technology. Over the past 20 years, the production of 7-ACA and 7-ADCA has been monopolized by the three major pharmaceutical manufacturers, namely Italy’s Antibioticos, Austria’s Biochemie and the Netherlands’ DSM. DSM is currently the largest 7-ADCA manufacturer in the world with an annual production capacity of 1,000 tons. The world’s total production of 7-ADCA had surpassed 6,000 tons as of the end of 2006. Major producers and exporters of the product include the Netherlands, Italy, the US, Spain, South Korea and India.

Today, in addition to Lunan Pharmaceutical, Shanghai Whyte Asia Pioneer Pharmaceutical, a joint venture of Shanghai Asia Pioneer Pharmaceutical, has also started the production of 7-ADCA for internal use exclusively rather than for sale. Other Chinese pharmaceutical makers that have shown interest in 7-ADCA as well include Zhuhai United Laboratories and Shanxi Weiqida Pharmaceutical. Furthermore, Hunan Nonferrous Chembio Biology Medicine, which completed a 6-APA production line in 2007, may also join the growing roster of 7-ADCA makers.

The 7-ADCA market is facing several uncertainties, including rising prices worldwide and challenges from 7-ACA, although the API is believed to have promising prospects looking forward.

China has become the world’s primary producer of penicillin industrial salt, laying a sound foundation for the further development of the 7-ADCA market. Besides, the 7-ADCA export market should face a bright future if production costs and price for the product can be further lowered.


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