| By Alex Shaw, Pharmaceutical Manufacturing News |
| Wednesday, 25 March 2009 |
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In spite of the rapid growth seen in the pharmaceutical excipient market worldwide over the last few years, certain issues continue to dog China’s pharmaceutical excipient sector: products of poor quality, insufficient production capacity, lack of specialized manufacturers, low level of competence in research and
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development, as well as cutthroat competition. At the 2009 Pharmaceutical Excipient Summit held in Shanghai, representatives from pharmaceutical excipient makers, universities and pharmaceutical associations across the country held in-depth discussions over the future development of China’s pharmaceutical excipient sector.
While the ongoing global financial turmoil has posed tough challenges to China’s pharmaceutical export business, exports of Western preparations from the country posted a year-on-year increase of 41.8 per cent last year. By contrast, the country’s pharmaceutical excipient sector still lags behind and fails to meet the growing market demand for high-quality product.
China is currently home to between 200 and 300 excipient manufacturers, with only a limited number of them specializing in the production of the excipients. Most of these producers have annual sales |
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below RMB100 million (approx. US$15 million). The lack of uniform standards when it comes to the manufacturing and application of pharmaceutical excipients is another challenge facing the makers. 72 variants of pharmaceutical excipients are listed in the 2005 version of the Chinese Pharmacopoeia, compared to about 500 that can potentially be used in production process, according to Ping Qineng, a professor of China Pharmaceutical University.
In addition, the falling prices for pharmaceutical products generally speaking as a result of the implementation of bidding policies, together with the skyrocketing raw material costs, have exerted significant pressure on excipient producers. BASF raised prices for its pharmaceutical excipients by 9 per cent in May 2008 due to the rising raw material, energy and transportation costs, while U.S.-based FMC BioPolymer has raised the price of its pharmaceutical celluloses by 8 per cent. However, a number of Chinese excipient manufacturers, which are under pressure on all fronts, are struggling with a margin squeeze.
Ping also encouraged China’s pharmaceutical excipient sector to embrace a production model based on specialization. Some foreign manufacturers focus on one or several excipients and on improving their products in accordance with the requirements of end-users and |
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preparation makers, while some invest considerable resources in mixing and blending pharmaceutical excipients based on different formulations to deliver a wide array of features. Furthermore, China’s excipient producers are advised to pay particular attention to technologies and services. Anhui province-based Shanhe Pharmaceutical Excipients plans to establish a laboratory to develop innovative pharmaceutical excipients, while providing technical support to preparation manufacturers.
As more excipient makers from outside of China are seeking contract manufacturing partners in the country, its manufacturers need to set up production lines in compliance with international standards to win overseas orders, grabbing a larger share in international markets. The global market for pharmaceutical excipients, which was worth US$3.5 billion in 2006, is expected to cross the four billion dollar mark by 2011, reaching US$4.3 billion.
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