API China will be held in Qingdao during Jun.9-11,2020

API China will be held in Qingdao during Jun.9-11,2020

中国国际医药原料药/中间体/包装/设备交易会(API China)组委会一直密切关注疫情发展,结合业界实际情况认真研判并作风险评估,通过和政府部门及展馆方的紧密沟通,我们非常高兴地通知您,第84届中国国际医药原料药/中间体/包装/设备交易会(API China)将于2020年6月9-11日在青岛世博城国际展览中心如期举办。

India restricts exports of 26 APIs and preparations

  1. 限制出口的清单(见附件),以及英文新闻链接

    • The Indian Government said there were enough stocks to manufacture formulations for up to three months
    • The export restriction list includes several antibiotics, the hormone progesterone and vitamin B12
    • It is unclear how the restriction would impact the availability of these medicines in countries that import from India 
  2. 限制出口的原因:受疫情影响,需要优先供应印度国内 Reasons for export restrictions: Affected by the corona-virus, Priority is given to protecting the domestic market

  3. 对中国及其他国家的影响 Impact on China and other countries & areas

    • 据外媒报道,部分关键原料药已经上涨10% – 50% According to foreign media reports, some key APIs have risen by 10%-50%
    • 全球需求急剧增长,中国企业产能还没有完全恢复,中国的原料药及中间体涨价已成定局 Global demand has increased sharply, however Manufacture industry in China has not yet fully recovered, under such, Prices of APIs & intermediates in China will be keep rising.
    • 对于中国的制剂厂来讲,原料药涨价,但制剂价格受限制不能上涨,有可能亏本甚至停产,中国近九千药品面临成本危机 the price of APIs has risen, but the price of preparations in China cannot be rised due to restrictions, It may be at a loss or even stop production. Nearly 9,000 drugs (preparations) in China are facing a cost crisis.

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

翻译:JULIA 来自:Julia法规翻译




FDA Statement

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine


For Immediate Release:

September 13, 2019

Statement From:

Director – Center for Drug Evaluation and Research

Janet Woodcock M.D.

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.


The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.


When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available.


Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking themout weigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.


Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.


The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available.


The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs onthe market that are approved for the same or similar uses as ranitidine.


Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch programto help the agency better understand the scope of the problem:


  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • 在线填写并提交报告
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
  • 下载并填写适当表格后通过传真提交

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




EMA to review ranitidine medicines following detection of NDMA


13 September 2019


At the request of the European Commission, EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA).


NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It ispresent in some foods and in water supplies but is not expected to cause harm when ingested in very low levels.


EMA is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.


Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.


Patients who have any questions about their current treatment can speak to their doctor or pharmacist. There are several other medicines used for the same conditions as ranitidine that could be used as an alternative.


In 2018, NDMA and similar compounds known as nitrosamines were found in a number of blood pressure medicines known as ‘sartans’, leading to some recalls and to an EU review, which set strict new manufacturing requirements for these medicines.


EMA is currently working on guidance for avoiding nitrosamines in other classes of medicines. EMA will continue to cooperate with national authorities, EDQM and international partners to protect patients and ensure that effective measures are taken to prevent these impurities from being present in medicines.


More about the medicine 关于该药品

Ranitidine belongs to a class of medicines known as H2 (histsamine-2) blockers, which work by blocking histamine receptors in the stomach and reducing the production of stomach acid.


It is used to treat and prevent conditions caused by excess acid in the stomach such as heartburn and stomach ulcers.Ranitidine-containing medicines are authorised by national authorities and are available as tablets and injectable formulations.


More about the procedure 关于程序

The review of ranitidine medicines was initiated on12 September 2019 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.


The review will be carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.


The Yima gasification plant

The Yima gasification plant in Sanmenxia City, central China’s Henan Province, exploded on Friday at about 17:45 PM Jul.19,2019, More than 12 people died in the accident. The plant has employees of 1300, main products are methyl alcohol / dimethyl ether / acetic acid / gas / liquid ammonia / dilute nitric acid / ammonium nitrate & etc…