Fighting tuberculosis: EUROAPI’s rifampicin API meets new requirements for nitrosamine impurity standards
The effects of N-nitroso compounds on human health (particularly their role in gastric cancer) are well known.1 Certain N-nitrosamines are described as highly probable human carcinogens. They are usually formed by the reaction of secondary or tertiary amines with a source of a nitrosating agent, typically derived from nitrite.2,5
Health Canada Issues Recall of AA Pharma`s Amitriptyline antidepressant drugs
Jan 17 (Reuters) - Merck & Co (MRK.N) has discovered how its blockbuster diabetes drugs have become contaminated with a potential carcinogen and believes it can resolve the problem by the end of the year, Bloomberg News reported on Tuesday.
More than a year ago, disappointing data from a key Phase III seemingly shattered Deciphera’s hopes of moving its kinase inhibitor into earlier lines of cancer treatment. But now a new subgroup analysis may yet revive those hopes — albeit in a smaller group of patients.
In Feb. 2021, the FDA called on all drug manufacturers to improve the safety of the US drug supply and conduct risk assessments of all approved or marketed products to detect potentially cancer-causing nitrosamine impurities.
The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.
In the words of Daft Punk, one more time. On October 25, the U.S. Food and Drug Administration (FDA) announced yet another blood pressure medicine recall for contaminants that may cause cancer, a problem that has occurred far too many times since 2017. This time the company is Aurobindo Pharma USA, Inc. The blood pressure medication being recalled is Quinapril and Hydrochlorothiazide Tablets USP in 20 mg and 12.5 mg doses, respectively. And the contaminant is Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril in levels that exceed acceptable limits.
Indian generics manufacturer Aurobindo is having to pull another product off the shelves.
Safe approach in delivering nitrosamine-free API products