Strides announces relaunch of ranitidine tablets for the US Market

Strides has announced the relaunch of ranitidine tablets for the US market,t the company said in a release. It also stated that the United States Food and Drug Administration (USFDA) had tested numerous ranitidine tablets in the market over the past few months and released a summary of the results on November 1, 2019. The agency had indicated that if the NDMA levels were above the acceptable limits (96 nanograms per day or 0.32 ppm), they are asking companies to recall ranitidine products voluntarily.

Strides’ ranitidine tablets 300 mg (Rx) 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. On the basis of the outcome, the company has decided to relaunch its product with immediate effect.

Strides has approvals for ranitidine tablets USP 150 mg and 300 mg. According to IQVIA MAT data, the US market for ranitidine tablets USP 150 mg and 300 mg is $76 million. The company also has approvals for several OTC strengths but has not commercialised these products.