Strides Pharma suspends ranitidine sales in US
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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).
New Delhi: 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 $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.
