Product
Supplier
Encyclopedia
Inquiry
Home > News > Market Flash > The European Union completely banned ranitidine or carcinogens

The European Union completely banned ranitidine or carcinogens

ECHEMI 2020-05-07

Recently, the European Medicines Agency EMA issued a document, and the EMA Human Medicines Committee (CHMP) recommended that all ranitidine drugs in the European Union be stopped because of the low level of NDMA impurities.
 
According to animal studies, NDMA is classified as a possible human carcinogen (a substance that can cause cancer). It exists in the supply of certain foods and water, and if ingested at very low levels, it will not cause harm.
 
The current safety data does not show that ranitidine increases the risk of cancer, and all possible risks are very low. However, NDMA has been found to exceed acceptable levels in several ranitidine drugs, and the source of the impurity is unknown.
 
The documents show that many ranitidine drugs have not been listed in the European Union for several months because of the recall of the US national department as a preventive measure during the EMA review.
 
EMA also proposed conditions for canceling the suspension of ranitidine, including requiring the company to submit more data.
 
Since 2018, NDMA and similar compounds have been detected in a large number of drugs, and EU regulatory agencies have taken measures to find possible sources of these impurities and set strict new requirements for manufacturers.

The NDMA turmoil has been upgraded again-30 days after the US FDA required all ranitidine products to be withdrawn from the market, the European Union also required a total ban on the use of ranitidine drugs.
 
On April 1, the US FDA requested in its announcement that manufacturers immediately withdraw all prescription and OTC ranitidine drugs from the market-this is an ongoing investigation of the contaminant nitrosamine impurity (NDMA) in ranitidine drugs The latest measures taken afterwards.
 
The reason is that the FDA has determined that if some Ranitidine products are stored in an environment above room temperature, the impurities in them will increase with storage time, and lead to consumer exposure to unacceptable levels of impurities.
 
Because the US Food and Drug Administration requires a comprehensive and immediate recall, after this, there will be no new or old ranitidine products for prescription or non-prescription use in the US market.
 
According to incomplete statistics, many pharmaceutical companies such as Novartis, GSK, Sanofi, Teva, and Dr. Reddy have already recalled ranitidine.

Disclaimer: ECHEMI reserves the right of final explanation and revision for all the information.
Comment
Comment

Trade Alert

Delivering the latest product trends and industry news straight to your inbox.
(We'll never share your email address with a third-party.)

Scan the QR Code to Share

Feedback & Suggestions
Send Message

Thank you for your feedback. If you require further assistance, please contact us by email at info@echemi.com or call us at +86-532-55729510.