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Thread #valsartan #ranitidine NDMA impurity.....
Last year when the US FDA sent out a warning letter to China's Zhejiang Huahai (ZHP) for NDMA impurities, a known carcinogen, a few large Indian drug makers may have felt the chill...one of them is Hyderabad-based Hetero Drugs.
Last year when the US FDA sent out a warning letter to China's Zhejiang Huahai (ZHP) for NDMA impurities, a known carcinogen, a few large Indian drug makers may have felt the chill...one of them is Hyderabad-based Hetero Drugs.
Following ZHL, Hetero is learnt to have changed the manufacturing process for valsartan API. Since it meant fewer stages of manufacturing, it more or less became an industry norm to adapt to a new way to cut costs; being ahead in the market competition was a priority
ZHP was reported to have used sodium azide, which leads to higher yields as compared to tributyltin azide, that was used by Sandoz. However, what was unclear was the use of solvent dimethylformamide may lead to carcinogens, though in small quantities. Some chemistry..
