Vibhu

Brychem (UK), 34, The Drive, Orpington, Kent BR6 9AP, United Kingdom Tel.: +44 1689 600 501. Fax: +44 1689 897 786.
The recent scandal over the corrupt China is rapidly catching up Italy (with based resource to assist industry par- administration of Chinese GMP certifica- around 525 registrations) and will no ticipants outside of China to develop a tion is unlikely to greatly slow down the doubt challenge India (holding over 1,350 better understanding of the producers, growth of the Chinese pharmaceutical in- US DMFs) within the next few years.
dustry and its increasing role as a leading In this short article, Dr Rob Bryant of based upon the data published by the US Brychem Business Consulting explores the FDA on active registrations). To many recent changes in the Asian production of within the global PFC industry, the lead- APIs, with the emphasis on China’s industry. ing Indian company names are very fa- miliar. This is not the case for the much Over the past ten years, the Chinese more fragmented Chinese industry, which pharmaceutical fine chemical (PFC) in- continues to change and consolidate. For dustry has developed from being over- this reason, Brychem and WiCON Inter- whelmingly an exporter of intermediates national have recently published SNAPI, into a major producer of APIs for the glo- the first validated database of informa- bal drug industry. With over 450 APIs tion on the top Chinese API producers.
now registered for export to the USA, The intention has been to provide a web- Comparison of top US DMF holders in India and China (Aug 2007) Numbers of API companies in China’s leading provinces ity of the Chinese industry and the rapid industry (see http://www.brychem.co.
antibiotics. Having first wrested produc- tion of the majority of the world’s fer- Note: Data pertains to 650 companies reviewed in SNAPI to date mentation antibiotics from India, Chinese or tail of locally published information.
vast majority of the world’s top-selling barrier to Western individuals’ attempts to get to grips with the country, its peo- sources for many APIs (see Table 2).
customers no longer tolerate poor en- and China offer similar challenges to vironmental performance in the way Western customers. The proliferation of that they have done in the past. The companies and agents make it hard to Chinese regulatory authorities have sort the better companies from those that begun to take this issue very seriously would best be avoided. The sheer size of and many companies located in sensi- the country and the numbers of produc- tive areas (such as the Yangtse river ers (many of whom are only making for- basin) have had to spend considerable mulations, but happily resell their sup- sums on abatement projects or be pliers’ APIs) makes travel time-consum- w Process patents. As Chinese companies trated in several provinces (see Table 3), offer ever newer APIs, the processes this is only of limited help when under- being used are more likely to have in- taking a series of visits.
infringing routes is still often ignored and Indian companies should benefit from and this can result in expensive prob- a straightforward guide to the Chinese API industry. This is what the new online w Legal issues. India’s laws are similar to database, SNAPI (Sino-API), now pro- those operating in the majority of West- vides. Indian companies, in particular, ern markets, whereas the lack of trans- need to understand the threats and ben- parency of the China legal system is a efits being offered by China, so that they are able to plot a course for their busi- catching up with the best Indian produc- w Language and script. Like Japan, China nesses over the next 2-5 years. For with- has maintained a far greater air of mys- out doubt, the Chinese PFC industry will tery than India as a result of the inabi- only be ignored by Indian pharmaceuti- w Quality and reliability. Chinese GMP is lity of most Westerners to make head cal industry at its peril.

Source: http://www.snapi.eu/RJB_ChWk200709.pdf