Ranitidine is a commonly prescribed medicine for countering acidity and is on the WHO’s Model List of Essential Medicines.
Amid a raging controversy over commonly used heartburn drug Ranitidine, Mumbai-based Taj Pharmaceuticals Limited today said that its formulation drug is safe. The company said that the test results found that Taj Pharmaceuticals’ Ranitidine tablets was within the “acceptable limits” for the presence of a probable cancer causing substance. On 29th September 2019 US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or N-Niteosodimethylamine—in some Ranitidine medicines.
The company is likely to continue Ranitidine drug sale, following the report. “The Company intends to provide additional updates in the next coming days, including potential recommencement,” it said in a statement.
NDMA Risk Assessment Report is done in much more advanced for all potential APIs (Valsartan) on our ROS of Ranitidine Hydrochloride and analyzed few batches for NDMA content in Ranitidine HCL API by validated LC-MS/MS and GC-MS methods. As per our initial investigation and assessment report, it is found that the formation of NDMA in ROS of our Ranitidine Hydrochloride is negligible.
The Mumbai-based company Taj Pharmaceuticals had last month suspended the manufacturing and sale of the drug following concerns around the cancer-causing impurity called N-nitrosodimethylanine (NDMA).
Citing a FDA test report, the company on Monday said that “The agency tested numerous Ranitidine products on the market over the past few months and released a summary of the results they have to date. In the summary of test results Ranitidine Tablets Risk Assessment Report is within the acceptable limits for NDMA”.
Earlier in September, the US and European Union regulators had said that they were investigating the discovery of carcinogen NDMA, in branded and generic Zantac. However, this Friday, the U.S. drug regulator downplayed the risk caused by contamination and said its tests suggest it does not cause carcinogens.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that the levels of the probable carcinogen N-nitrosodimethylamine (NDMA) it found in Ranitidine – sold under the brand name Zantac – “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation’s Model List of Essential Medicines. In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug.
The market size for Ranitidine brand in India is Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.