Strides Pharma Science on Friday said it has relaunched Ranitidine tablets used in ulcer treatment in the US as the level of NDMA (N-nitrosodimethylamine) in its product was found to be within acceptable limits.
The company had suspended sales of its generic Ranitidine tablets after the US Food and Drug Administration (USFDA) found contamination in some Ranitidine tablets sold by various companies with potentially cancer causing impurities, NDMA.
USFDA had tested numerous Ranitidine tablets on the market over the past few months and released a summary of the results on November 1, 2019, Strides said in a regulatory filing.
The agency had indicated that if the NDMA levels were above acceptable limits (96 nanograms per day or 0.32 ppm), they are asking companies to recall Ranitidine products voluntarily, it added.
“Strides’ Ranitidine tablets 300 mg were within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm. Strides has now completed comprehensive testing of several of its batches available in market and in stock meeting the limits prescribed by the USFDA,” it said.
Basis the outcome, the company has decided to relaunch its product with immediate effect, it added.
Strides has approvals for Ranitidine tablets USP 150 mg and 300 mg.
Citing IQVIA MAT data, Strides said the US market for Ranitidine tablets 150 mg and 300 mg is around USD 76 million. RKL DRR.-Times Of India