Strides Pharma Science has received an approval from US Food and Drug Administration (USFDA) for Rx and OTC Ranitidine tablets for the US market and is only commercializing the Rx product currently.
The USFDA has 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. Basis a Citizen petition, the USFDA is now reaching out to all formulation companies to perform tests to evaluate presence of NDMA in the product.
The company has also received an Information Request (IR) from USFDA to provide test data in next 30 days. 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. Ranitidine tablets is amongst the top 5 products sold by the company in the USA.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.