message display from the US Pharmacopoeia (hereinafter referred to as "USP")，After the "Best Incident"，The third amendment standard of the FDA of the US Drug Regulatory Department for heparin products is about to be promulgated，New standards for impurities、The requirements for restrictions on the source of heparin raw materials are stricter。

According to the senior customer manager of USP China District, Hong Xin revealed，FDA The third phase of the standard for heparin product standards is being carried out，The quality standards of the sodium sodium sodium sodium stake betting appare revised and improved。

My stake betting appFuck Hong Xin revealed，USP's third amendment to the standard of heparin product standards includes: Improving the NMR method to determine OSCS (that is, one of the most important impurities of heparin，It is also the sensitivity of the culprit that occurred in the 2008 "sodium sodium incident") reached 0.1%，The sensitivity that previously required was 1.0%; at the same time，New revised standards also require strengthening the detection method of protein and nucleic acid，Detection limit drops from 1.0%to 0.1%。

"First Financial Daily" learned，FDA has invited major global suppliers, including the five major heparin companies including Changshan Pharmaceuticals to participate in the formulation of this standard，It will mainly use the BCA detection method (a method of detecting protein content) for calibration，Finally, the linear average may be taken as the reference。

Fuck Hong Xin disclosed，It is expected that the third stage of revision can be finalized and released in the second quarter of next year，At that time, it will be likely to add heparin sodium molecular measurement calibration and adenosine standard。

The United States is the world's largest heparin raw material market，In 2010, it accounted for about half of the global heparin raw material market。China currently supplies 60%of the world's heparin raw materials，Haipri (My stake betting app002399.SZ)、Qianhong Pharmaceutical stake sports betting app(002550.SZ)、Changshan Pharmaceutical (300255.SZ) and other major heparin ingredients suppliers have formed a large dependence on overseas markets，This time, the amendment of the amendment of the amendment of heparin products will inevitably affect related local companies。

According to the official website of the State Food and Drug Administration (SFDA)，At present, there are 24 companies in China that holds local heparin ingredients.，But only the United States FDA certification is two Hailipui and Qianhong Pharmaceutical。

Industry experts point out，At present, the domestic standards of heparin products are closer to the new USP standards in the United States，The main export companies have also used the standards of the United States or the European Union，So，The implementation of the new standard of USP in the United States has little impact on major local companies，But the production cost of the enterprise should be increased accordingly。

From the trend of the most important category of heparin ingredients, heparin sodium，Export prices in the third quarter of last year began to decline，The average export price in the first half of this year fell to $ 9163/kg，decreased by 12.16%year -on -year。On the other hand，From 2008 to 2010, the procurement cost of raw material procurement of heparin product manufacturers has increased by more than 2 times。From the mid -term performance stake sports betting appof stake online sports bettinglisted companies，Hai Purui、Qianhong Pharmaceutical also signs of decline in profit declines in the first half of this year。

Although the continuous upgrade of industry standards affects related companies，But in the long run，The market potential of heparin products is very considerable。Data Show of the Institute of Southern Medical Economics，By 2015, the market size of global heparin drugs will reach $ 7.9 billion。

Customs data display，In 2010, the export volume of domestic heparin products increased by 71.69%year -on -year to $ 1.198 billion，The compound growth rate in the past three years is 130.24%。At the same time, the export price of heparin products is growing rapidly，2008-2010 The average export price of domestic heparin products is 3473 US dollars/kg、$ 6249/kg and 10473 US dollars/kg。

But the price of heparin products is not only good for domestic enterprises。Our reporter learned，Currently Europe、India, etc., 5 or six heparin sodium companies with large production capacity of production capacity are preparing to restart production，The main reason is that the market price of heparin sodium has reached its cost and profit requirements，At the same time，These companies are very optimistic about the future market space of heparin sodium products。

This，Ji Shengli, general manager of Changshan Pharmaceutical, believes，Once the above -mentioned companies restart production，In the case where the price of the stake sports betting appproduct Stake Sports Bettingis not much different，European and American buyers usually prefer European and Indian suppliers，This will inevitably cause impact on local export companies。