GSK to discontinue production marketing of its Ranitidine tablets Zinetac in India

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Medical Dialogues has earlier reported that the U.S. Food and Drug Administration last month had requested that all forms of ranitidine (e.g., Zantac) be removed from the market as new studies indicate they may contain unacceptable levels of the impurity N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

This came after the agency determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans.

Read Also: FDA requests withdrawal of all Ranitidine products from market