Strides Pharma Science on Friday said it has suspended sales of ulcer-treating tablet ranitidine in the US following the USFDA finding contamination in some of such medicines with potentially cancer causing impurities, N-nitrosodimethylamine (NDMA).
Strides Pharma Science on Friday said it has suspended sales of ulcer-treating tablet ranitidine in the US following the USFDA finding contamination in some of such medicines with potentially cancer causing impurities, N-nitrosodimethylamine (NDMA). In a regulatory filing, the company said it has received an Information Request from the USFDA to provide test data related to NDMA impurities in ranitidine tablets.
“This data is to be provided to the agency in 30 days,” Strides said. While the company conducts the relevant tests mandated by the USFDA, Strides said it “has suspended sales of ranitidine tablets in the US market until such time it has clarity of next steps as would be indicated by the USFDA”. The company further said it predominantly sells ranitidine tablets in the US market, and its front end sales globally for the product were around USD 9 million in the first half of 2019-20.
“In spite of this temporary suspension of the ranitidine supplies, the company retains its FY’20 growth outlook for the US markets,” it said. On Wednesday, Strides had said that the United States Food and Drug Administration (USFDA) has learned that some ranitidine products contain NDMA at low levels.
The agency is examining the levels of NDMA in ranitidine and is evaluating any possible risks to patients. On the basis of a Citizen petition, the USFDA is reaching out to all formulation companies to perform tests to evaluate presence of NDMA in the product.
On Wednesday, GlaxoSmithKline Pharmaceuticals had also announced recall of ranitidine hydrochloride tablets produced in India using API sourced from Saraca Laboratories following detection of genotoxic nitrosamine NDMA by authorities.
The company has also decided to suspend release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations. In a separate filing, Strides said its step-down subsidiary Strides Pharma Global Pte Ltd Singapore has received nod from the USFDA for Solifenacin Succinate Tablets, 5 mg and 10 mg, which is the generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. The medicine is used to treat an overactive bladder.