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What Global Alert On Stomach Drug Means For Indian Pharma Companies

U.S. FDA found that anti-acidity drug ranitidine contains low levels of cancer-causing NDMA.

Merchandise sits on display for sale at a Walgreens Boots Alliance Inc. store in the Hollywood neighborhood of Los Angeles, California, U.S. (Photographer: Christopher Lee/Bloomberg)
Merchandise sits on display for sale at a Walgreens Boots Alliance Inc. store in the Hollywood neighborhood of Los Angeles, California, U.S. (Photographer: Christopher Lee/Bloomberg)

Watch | What Global Alert On Stomach Drug Means For Indian Pharma Companies

Indian drugmakers, particularly Strides Pharma Science Ltd., may face the impact of concerns about a generic anti-acidity drug after the U.S. regulator alerted patients and healthcare professionals of impurities.

Ranitidine, used to treat ulcers of stomach and intestine, contains low levels of a nitrosamine impurity called N-nitrosodimethylamine or NDMA, according to a press statement by the U.S. Food and Drug Administration. NDMA is classified as a probable human carcinogen or cancer-causing substance based on results from laboratory tests, it said.

The over-the-counter and prescription drug is the copycat version of Sanofi’s Zantac, which the company has stopped selling. Multiple global regulators are investigating the source and levels of NDMA in ranitidine and evaluating any potential risks to patients. The results of investigations are expected in the next two to three weeks. The U.S. FDA has not pulled out ranitidine from the market and is also not advising patients to stop taking the medicine. Health Canada, however, asked all ranitidine makers to stop distribution, while Italian and German regulators ordered a recall.

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Zantac and ranitidine sold by Strides Pharma contained very high levels of NDMA, according to a report by online pharmacy Valisure which conducted the tests and shared the data.

Strides is among the biggest manufacturers of ranitidine active pharma ingredient in the world and has supply agreements with many branded manufacturers for exports in semi-regulatory markets, Surajit Pal, analyst at Prabhudas Lilladhar, said in the note.

Amey Chalke, pharma analyst at HDFC Securities, said for Strides, rantidine is a sizable product if not the largest. If at all, the U.S. FDA decides to ban the drug with higher impurities, Strides may have to stop the supplies, he said.

Other Indian companies that sell ranitidine in the U.S. include Dr. Reddy's Laboratories Ltd., Glenmark Pharmaceuticals Ltd., Aurobindo Pharma Ltd., Cadila Healthcare Ltd., Sun Pharmaceutical Industries Ltd., Wockhardt Ltd., Ajanta Pharma Ltd. and Granules India Ltd., according to a note by HSBC.

Since the alert by the U.S. FDA, Dr. Reddy's has suspended distribution of the drug. The company is still evaluating potential impact, the company said in an emailed response to BloombergQuint.

Glenmark said it sells a "very small quantity" in the U.S. and none in India. Others ranitidine makers have yet to respond to queries.

Dr. Reddy's has $12-15 million annual revenues from the drug, while Aurobindo Pharma gets around $10 million, according to a note by Prabhudas Lilladhar.

Valisure also found high levels of NDMA in ranitidine sold by Walgreens and CVS Health. Anshuman Gupta, pharma analyst at Investec, said in a note that the American pharmacy chains sell it as private labels and could be sourcing from other manufacturers.