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Rantac safe for consumption, NDMA within permissible limits, manufacturer says

Earlier this week on September 23, the Drug Controller General of India (DCGI) asked state regulators to direct manufacturers of Ranitidine API to take measures to verify their products for the presence of NDMA, in order to ensure safety of consumers/patients.

September 30, 2019 / 03:21 PM IST
 
 
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JB Chemicals and Pharmaceuticals Limited on September 30 announced that it would continue to manufacture and sell Rantac after receiving initial reports from its active pharmaceutical ingredient (API) vendors.

This comes in the wake of the recent reports about the presence of impurity N-nitrosodimethylamine (NDMA) in the API of Ranitidine.

The company, which manufactures popular antacid formulation Rantac, has said in a press release that their Ranitidine API is manufactured by third party vendors, who have had their product analysed to check for the presence of NDMA. It added that initial test reports have suggested that the said impurity in the product is well within permissible limits.

The company also tested its other Rantac formulations, adding that NDMA in those was within permissible limits as well.

Popular via brand name drugs like Rantac, Aciloc, Zinetac and Zantac, Ranitidine is an over-the-counter prescription drug used to treat acidity and indigestion. It is most commonly used to treat and prevent stomach ulcers and works by reducing acid production in the stomach.

Earlier this week on September 23, the Drug Controller General of India (DCGI) asked state regulators to direct manufacturers of Ranitidine API to take measures to verify their products for the presence of NDMA, in order to ensure safety of consumers/patients.

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"As a responsible supplier of Rantac, we always take and shall continue to take all steps necessary for patient's safety including those directed by the Drugs Controller General (India). We wish to add that Rantac is being marketed by the Company for over 3 decades and so far no serious adverse events have been reported," the company said in the release.

This came nearly a week after the US Food and Drug Administration (USFDA) flagged concerns of presence of "low levels" of NDMA in Ranitidine. The International Agency for Research on Cancer has classifies NDMA as a probable carcinogen (cancer-causing substance).
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