Global Alert On Stomach Drugs
Indian Pharma giants, 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.
According to a press statement by the U.S. Food and Drug Administration, Ranitidine- A drug used to treat ulcers of stomach and intestine, contains low levels of a nitrosamine impurity called N-nitrosodimethylamine or NDMA. The US FDA said that NDMA is classified as a probable human carcinogen or cancer-causing substance based on results from laboratory tests.
Ranitidine over-the-counter and the prescription drug is the copycat version of Sanofi’s Zantac. Sanofi has stopped selling this drug.
Multiple global regulators are investigating the source and levels of NDMA in ranitidine and evaluating any potential risks to patients. The results of the investigations are expected in the next two to three weeks.
The U.S. Food and Drug Administration has not pulled out ranitidine from the market and is also not advising patients to stop taking medicine. Health Canada, however, asked all ranitidine makers to halt distribution, while Italian and German regulators ordered a recall.
Global Alert On Stomach Drugs- How is The Indian Pharma Companies Affected?
According to
a report by online pharmacy Valisure, Zantac and ranitidine sold by Strides Pharma contained very high levels of NDMA.Surajit Pal analyst at Prabhudas Lilladhar said that Strides is among the most prominent manufacturers of ranitidine active pharma ingredient in the world and has supply agreements with many branded manufacturers.
Amey Chalke, a pharma analyst at HDFC Securities, said for Strides, ranitidine 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.
Some of the Indian Companies that sell ranitidine include Dr. Reddy’s Laboratories Ltd., Glenmark Pharmaceuticals Ltd., Aurobindo Pharma Ltd., Cadila Healthcare Ltd., Sun Pharmaceutical Industries Ltd. among others.
According to Prabhudas Lilladhar, Dr. Reddy’s has $12-15 million annual revenues from the drug, while Aurobindo Pharma gets around $10 million,
We will have to wait until the US FDA comes up with some official press release.
