Last Updated : Monday, November 4, 2019 18:53:43

STRIDES PHARMA : USFDA announces Lab testing & analysis of Ranitidine Tablets

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered Pharma company Strides Pharma Science Ltd said of having its Rantidine Tablets tested by USFDA and the regulator has announced testing & analysis results of the company terming as NDMA (nitrosodimethylamine) levels with acceptable limits.

The company press-release as issued to the Indian Bourses titled – “USFDA announces Laboratory testing and analysis of Ranitidine and issues statement with acceptable NDMA limits” read that, Strides’ Ranitidine Tablets 300 mg lots tested by USFDA are within the acceptable NDMA limits.

The release further read that, the USFDA issued a statement1 on November 1, 2019 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, USFDA indicated if they or the manufacturers find NDMA levels above the acceptable limits(96 nanograms per day or 0.32 ppm), they are now asking companies to recall ranitidine voluntarily.

In the summary of test results2 provided by USFDA, Strides’ Ranitidine Tablets 300 mg (Rx) is within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm.

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

The Company 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.


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