Strides Pharma Science has received an Information Request (IR) today , 25 September 2019 from USFDA to provide test data for evaluation of presence of NDMA in Ranitidine tablets in next 30 days. The USFDA has reached out to all formulation companies to perform such tests. The company is in the process of responding to the IR comprehensively. Further updates on the product will be provided post completion of the requisite tests.
Strides has approval for Rx and OTC Ranitidine tablets for the US market and is only commercializing the Rx product currently.
Previously, the USFDA learned that some ranitidine products contain a nitrosamine impurity called N]nitrosodimethylamine (NDMA) at low levels. NDMA is also found in water and foods, including meats, dairy products, and vegetables and is not expected to cause harm when ingested in very low levels.
USFDA is not calling for individuals to stop taking ranitidine at this time. The agency is examining the levels of NDMA in ranitidine and is evaluating any possible risks to patients.
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