New Delhi: Strides Pharma Science Ltd on Friday announced the relaunch of popular antacid ranitidine for the US market with immediate effect after the presence of the carcinogen N-nitrosodimethylamine (NDMA) was found within acceptable limits.
“Strides’ ranitidine tablets 300 mg were within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm (parts per million). Strides has now completed comprehensive testing of several of its batches available in market and in stock meeting the limits prescribed by the USFDA," the company said in a release.
Strides Pharma has US Food and Drug Administration (FDA) approval for ranitidine tablets of strength 150 mg and 300 mg, which according to market research firm IQVIA’s data, has a market of about $ 76 million, the company said.
At 2pm, shares of Strides Pharma traded 1.3% higher at Rs403.55 on the BSE.
The company had halted sales of the antacid in the US in September following a safety alert by the US regulator, which cited traces of NDMA, a known carcinogen, in the product.
Following the US regulator’s safety alert, the Drug Controller General of India also issued a directive to all state regulators asking them to get manufacturers to test anti-acidity drug ranitidine for the impurity. Many other drug regulators world over have also issued similar advisories and are conducting tests.
Dr Reddy’s Laboratories had also initiated a voluntary recall of the medicine at the retail level in the US on 1 October after the US FDA’s caution note.
On 25 September, GlaxoSmithKline Pharmaceuticals Ltd suspended the distribution and supply of ranitidine hydrochloride products to all markets, including India, as a precautionary measure after regulatory authorities detected the carcinogen in its products.
However, last week, the US regulator downplayed the risk associated with popular antacid medicine ranitidine, saying that levels of NDMA in most samples, after numerous tests, were found to be similar to those in common foods.
“The agency has tested numerous ranitidine products on the market over the past few months, and today we’re releasing a summary of the results we have to date. Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats," Janet Woodcock, director at the regulator’s Center for Drug Evaluation and Research, had said in a statement.