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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..
Great work by a few chemistry blogs ...Back to India - Hetero was notified after checks by the US FDA about the presence of NDMA impurities. It was supplying APIs to Indian drug makers for local market. Lupin was one such company that sourced part of its requirements from Hetero
Lupin's own manufacturing unit was used to full capacity to cater to the US market and so it roped in Hetero for local supplies. Getting a US FDA site of Hetero to supply for the local market was a good business decision to ensure good quality products in India...
Then last year I saw @Teensthack reported some valsartan brands were in shortage, my curiosity took me deeper into the subject. The story unfolded...Lupin had in its lab tested the drug for NDMA impurities and found the presence of the substance.
Lupin alerted Hetero and for its part issued notices of recalls. Hetero did not respond to @ETPrime_com's questions. I checked with a senior health ministry official on the government action..I was told random samples were tested but nothing was found in those tests....
Hoping the ranitidine fiasco is handled better, now that the central regulator issued orders yesterday to state-level regulators to "verify" the issue and do the needful...
Rest we will watch closely...Does this help? @d_s_thakur and @AnooBhu ...My first twitter thread..apologies if the flow is not ok. @ETPrime_com story here: prime.economictimes.indiatimes.com/news/70371578/…
