Novartis takes the initiative to stop Renitin's global distribution

Medicines Network September 23rd, in the face of the discovery of suspicious impurities in Renitin, the situation of suspicious impurities of NDMA, multinational regulatory authorities have responded one after anotherNovartis offered to stop Renitin's global distribution business, while Seiberblue's website on the State Drug Administration's website, with "Reinitinin" as the key word query, has a total of 579 approval numbers, which in part means that these domestic pharmaceutical companies with approvals should also be cautiousNovartis, Renitin Global DistributionOn September 19th, according to foreign media, Fierce Pharma, the FDA has found suspicious impurities in NDMA in drugs such as Zantac, a company, and regulators around the world have taken a different approach, when neither the FDA nor other competitors acted, Novartis decided to stop distributing its generic version of Renitin worldwideThe FDA decided that there was no need for drug companies to recall their generic renitin enough to investigate, while Canadian and other European regulators took a more aggressive approach, requiring drugmakers to stop distributing, unlike recalls, meaning they could sell stocks of drugs already in storesSingapore authorities said in a statement that Singapore would immediately suspend the sale and supply of eight relateddrugsnovartis,, said On Wednesday that it was halting the global sale of its generic version of Renitin, and regulators were investigating the fact that the drug, based on Renitin, had been monitored for the impurity N-nitromadilamine (NDMA)"Until further clarification, all of our market sales bans on Sanders Reinitin will remain in place, including capsule preparations in the United States," Eric Althoff, head of global media relations at novartis, said in an emailat the same time, Eric Althoff said: 'We are conducting an internal investigation to determine more details and, if concerned, will work with the relevant health authorities to implement appropriate additional measures as neededlast week, the FDA reminded the public that NDMA had been found in some renitin drugs and was studying to determine the source of contaminated ingredients and their risk stake in those drugs, which the FDA says appear to be small, after Huahai Pharmaceuticals, and pharmaceutical companies found that the NDMAthing originated in August 2018, Zhejiang Huahai Pharmaceuticals in its production of general-purpose shattan antihypertensive drugs found NDMA, which made the European Union and the FDA and other institutions to conduct in-depth researchNDMA is considered a possible carcinogen by the Environmental Protection Agency, an organic chemical that was once used to make rocket fuel and is an unintended by-product of certain chemical reactionsThe discovery has attracted widespread attention from many manufacturers and product recallsbecause Huahai Pharmaceuticals is the world's leading producer of the drug, the incident has also had a greater negative effect on the pharmaceutical companies themselves, while the price of the drug has soaredA year after, the FDA announced the presence of potential NDMA carcinogens in Zantac and other renitin drugs, but this time adopted a more lenient attitudeThe FDA said that while NDMA may cause cancer, preliminary tests show that the level of carcinogens in the drug is no higher than that in food, so the FDA did not require patients to discontinue Zantac, a total of 57
9 approval synthspublic information shows that Renitin was first developed by John Bradshaw's Allen and Hanburys Ltd., a subsidiary of GlaxoSmithKline, which was first listed in the UK in October 1981The original research company is GlaxoSmithKlineone of the current FDA recommendations of the reference preparations is Novartis Sands 150mg and 300mg of renitinatin capsules, although not the original development agent, but because Novartis is an international well-knownenterprises, products sold globally, safety and effectiveness can be guaranteedit is understood that renitin, also known as furan nitrosamine, is an antagonist for the powerful histamine H2 receptorThe effect is 5-8 times stronger than simitin, with the characteristics of fast efficacy, long maintenance time, small toxic effect, clinically commonly used in the treatment of duodenal ulcers, stomach ulcers, upper digestive tract bleeding, postoperative ulcers, reflux esophagitis and so onand H2 receptor antagonists on the market for peptic ulcer therapy in China are six products such as rosatin, lapitin, famotitin, simittin, nizatinandin ei and renitinSeiber Blue in the State Drug Administration's official website query found that "Rainitin" as the key word query, a total of 579 approval numbers, enough to prove that the number of enterprises involved need to be on guard immediately for these companies