BRIEF—FDA says Strides' ranitidine within acceptable NDMA limits

The US Food and Drug Administration issued a statement1 on Friday, November 1, providing an update with the latest information on ranitidine.

The agency tested numerous ranitidine products on the market over the past few months and released a summary of the results they have to date.

In this statement, US FDA indicated if they or the manufacturers find a contaminant known as N-nitrosodimethylamine (NDMA) levels above the acceptable limits (96 nanograms per day or 0.32 ppm), it is now asking companies to recall ranitidine voluntarily.

In the summary of test results provided by US FDA, Indian drugmaker Strides’ Ranitidine Tablets 300mg (Rx) is within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm, with the news pushing the company’s shares up 3.38% to 402.15 rupees this morning.

Several batches of other manufacturers are above this limit requiring a voluntary recall.

Strides says it intends to provide additional updates in the next coming days, including potential recommencement of product distribution by Strides of ranitidine Rx based on available test results.

1 https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impuritiesranitidine-drugs