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China Imposes Hefty Fine on Three API Manufacturers for Violations of Anti-Monopoly Rules

In December, China’s State Administration for Market Regulation (SAMR) fined three domestic API (active pharmaceutical ingredient) manufacturers 12.8338 million Yuan (about 1.86 million dollars) for violation of anti-monopoly rules associated with attempts to artificially fix and inflate the price of glacial acetic acid. The penalty is the biggest ever anti-monopoly fine handed down to enterprise operating in the API industry. The fine includes confiscation of illegal gains (6.5822 million Yuan) and 4% of their last year's sales (6.2516 million Yuan).

The three companies are:

  • Chengdu Huayi Pharmaceutical Accessories Manufacturing Co. Ltd.

  • Sichuan Jinshan Pharmaceutical Co., Ltd.

  • Guangdong Taishan Xinning Pharmaceutical Co., Ltd.

These three are the only manufacturers of glacial acetic acid for API use in the Chinese market. They were found illicitly exchanging sales data from Oct 2017 to Feb 2018 in an attempt to price fix and realize an overall increase from the usual price of 7 to 9 yuan per Kg all the way to 28—33 Yuan per Kg in March of this year.

Glacial acetic acid is used as the main API for manufacturing hemodialysis concentrate for the treatment of end-stage kidney disease, uremia and other diseases. Their price fixing severely disrupted the market and significantly increased the costs of downstream pharmaceutical companies and ultimately endangered the treatment of patients needing dialysis. The companies involved have been ordered to make immediate rectification and normalize the price.

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