China Increases Exports of Statins-Series APIs

By Zhu Renzong

In the current market, the main statins-series medicines are atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, pitavastatin or their salified products.

Export of statins-series  APIs

As of 2014, China has granted licenses to manufacture statin active pharmaceutical ingredients (APIs) to 46 domestic companies. In 2013 China produced more than 1000 tons of statin APIs, and exported more than 500 tons. In 2014 China exported 506 tons of statin APIs at a value of US$82.24 million, with an average price growth of 18% over 2013. The export value in 2014 increased little from 2013.  
Simvastatin and lovastatin together accounted for more than 85% of the value of the statin APIs exported in 2014. By weight, the export share of simvastatin and lovastatin APIs was 95%. Other statin APIs exported by Chinese companies are atorvastatin, pravastatin, mevastatin, rosuvastatin, etc.  
India was the main export destination for China-made statin APIs in 2014, accounting for 57% of the total export value. Germany, Spain, Brazil and Poland ranked second to fifth, with the value of exports to these countries accounting for 16% of the total.
China’s top five exporters of statin APIs in 2014 were Livzon New North River Pharmaceutical Co., Ltd., Zhejiang Medicine and Healthcare Import and Export Company Ltd., Zhejiang Hisun Pharmaceutical Co., Ltd., Chongqing Daxin Pharmaceutical Co., Ltd. and Huatai Import and Export Company of Jiangsu Guotai International Group, their combined export value of statin APIs being 64% of the total.   

Exports of statin intermediates

In recent years, China’s export of statin intermediates followed a pattern similar to that of statin APIs. In 2012 the export of statin intermediates reached US$99.51 million, a historical high. In 2013 and 2014 the export of statin intermediates was around US$80 million. In 2014, China exported 555 tons of statin intermediates at a value of US$76.56 million, with volume down 12% from 2013 and value down 4.5%; the average export price rose however, by 8%.
Atorvastatin is the main statin intermediate China exports, contributing 77% of the total value in 2014. Next are rosuvastatin methyl ester and rosuvastatin calcium, together accounting for 22% of the total value. China mainly exports statin intermediates to India, Israel and Mexico. The export value to these three countries together accounted for 80% of the total last year.
In 2014, China’s top five statin intermediates exporters were Zheijang Neo-Dankon Pharmaceutical Co., Ltd., Jiangsu Province Alpha Pharmaceutical Co., Ltd., Nanjing Yali Chemical Co., Ltd., Ninhua Group Co., Ltd. and Anhui Menovo Pharmaceutical Co., Ltd.. The first two of these contributed 90% of the total export value.

Trade analysis by product

Simvastatin
Zhejiang Hisun Pharmaceutical Co., Ltd. started in 2002 to manufacture simvastatin API and has gained great profit from exporting it. In 2003 alone, Hisun recorded a total revenue of RMB600 million for the sale of simvastatin in domestic and foreign markets.  
At present, 24 companies in China hold production licenses for simvastatin API. Their total output was estimated to be 300 tons in 2014. Two firms, Zhejiang Jiangbei Pharmaceutical Co., Ltd. and Hisun, produced more than half of that. Ten simvastatin makers in China got either COS/CEP certification from the EU or approval of GMP.
Simvastatin accounts for more than 50% of the export value of China-made statin APIs. In 2014 China exported 180.6 tons of simvastatin, a decline of 14.7% compared with the historical high in 2013.
In 2014 the simvastatin exported to India accounted for 45% of the total value of China’s exported simvastatin, and that sent to EU accounted for over 30%. The rest went to Brazil, Thailand, etc. Among the exporters, Hisun, Zhejiang Jiangbei Pharmaceutical Co., Ltd. and Henan Topfond Pharmaceutical Co., Ltd. ranked in leading positions. Special traders like Jiangsu Guotai International Group and Zhejiang Medicine and Healthcare Import and Export Company Ltd. also held leading positions.
Lovastatin
China has granted 11 companies production licenses for lovastatin API, and their combined output amounted to 400 tons in 2014. Hisun, Livzon New North River Pharmaceutical Co., Ltd. and Chongqing Daxin Pharmaceutical Co., Ltd. are the top three makers. Hisun has COS certification from the EU, and the other two have FDA certification from the USA.  
Lovastatin API contributes one third of China’s total export value of statin APIs. In recent years the biggest annual export volume of lovastatin API happened in 2011, being 395.3 tons but the average export price was only US$81 per kilogram, the lowest in the past five years. After 2011, China’s lovastatin export volume declined year by year, while the export price rebounded. In 2014, China exported 299.2 tons, down 17.8% from 2013; and the export value was US$28.69 million, a decline of 11.9% year on year.  
In 2014 India imported 77% of China’s exported lovastatin, by value. Other export destinations included the USA, China Taiwan, Canada, Malaysia, etc.
Among exporters, Livzon New North River Pharmaceutical Co., Ltd., Chongqing Daxin Pharmaceutical Co., Ltd. and Zhejiang Medicine and Healthcare Import and Export Company Ltd. were the top three exporters by value, accounting for 95% of the total.
Atorvastatin calcium and atorvastatin intermediates
China has licensed 11 companies to produce atorvastatin calcium API, but their combined output was estimated to be less than 100 tons in 2014. Even the principal makers, such as Hisun, Topfond and Zhejiang Hongyuan Pharmaceutical Co., Ltd. produced little in 2014. In contrast, China is estimated to have produced over 400 tons of atorvastatin intermediates in 2014. Zhejiang Neo-Dankon Pharmaceutical Co., Ltd., Jiangsu Province Alpha Pharmaceutical Co., Ltd. and Anhui Menovo Pharmaceutical Co., Ltd. are the major makers of atorvastatin intermediates. Between 2009 and 2012, China’s export of atorvastatin APIs and intermediates grew rapidly, hitting an all-time high of 365 tons in 2012. In 2013 and 2014 the amount went down slightly, hovering around 360 tons.
China exported 13.8 tons of atorvastatin API in 2014. By value, 55% went to India and 40% to the EU. Hangzhou Sinolite Industrial Co., Ltd. and Zhejiang Neo-Dankon Pharmaceutical Co., Ltd. were the two biggest exporters.
In contrast, the average export price of atorvastatin intermediates declined steadily between 2011 and 2014, falling 32%. In 2014 China exported atorvastatin intermediates worth US$58.61 million, a year on year decline of 9%. The export value to India, Israel and Mexico accounted for 31%, 25% and 22% respectively of the total, with year-over-year changes of -42%, +92% and -17%. Zheijang Neo-Dankon, Jiangsu Province’s Alpha, Nanjing Yali Chemical, Ninhua Group and Anhui Menovo were the major exporters.
Rosuvastatin calcium and rosuvastatin intermediates
China has licensed six companies to produce rosuvastatin calcium API, the total output is very small and exports in 2014 totaled less than 2 tons. Still, it is reasonable to expect growth in the future. The output and export of rosuvastatin intermediates both are already big. China’s exports of rosuvastatin calcium and rosuvastatin methyl ester increased rapidly in the past five years, together reaching 277 tons in 2013 but sliding to 205 tons with export value of US$16.65 million in 2014. Rosuvastatin calcium and rosuvastatin methyl ester were exported mainly to India and Israel, which together imported more than 80% of the total. Zhejiang Neo-Dankon and Jiangsu Province’s Alpha were the main exporters, contributing 92%.
Mevastatin and pravastatin sodium
China has licensed four companies to produce pravastatin sodium API, including Hisun, Guangdong Lanbao Pharmaceutical Co., Ltd. and Livzon New North River Pharmaceutical Co., Ltd. Their combined output was estimated to be a few dozen tons in 2014. These three companies are also the main producers of mevastatin, with a combined output exceeding 300 tons in 2014.
China exported more than 155 tons or US$16.5 million of mevastatin in 2011. Since then, the export volume has decreased year by year, reaching about 130 tons in 2014, with the main destination being India.
The historical high of nearly 10 tons of exported pravastatin sodium was achieved in 2012. Only 2.2 tons was exported in 2014.
Fluvastatin sodium and pitavastatin calcium
In China, only Hisun and Shenzhen Salubris Pharmaceutical Co., Ltd. have permits to make fluvastatin sodium API. Annual output is several tons, and there is virtually no export.
China Resources Double-Crane Pharmaceutical Co., Ltd., Shandong Qidu Pharmaceutical Co., Ltd., Zhejiang Jingxin Pharmaceutical Co., Ltd. and Xuzhou Wanbang Jinqiao Pharmaceutical Co., Ltd. are authorized to make pitavastatin calcium API. Among them, China Resources Double-Crane is in a leading position.