Strides Pharma Science on Friday said it has suspended sales of ulcer-treating tablet ranitidine in the U.S. following the USFDA finding contamination in some of such medicines with potentially cancer causing impurities, N-nitrosodimethylamine (NDMA).
The ministry at that time tested Zantac and some other 35 generic drugs sold in Korea but found no NDMA in them. For starters, it's a popular prescription drug often used to "treat and prevent gastroesophageal reflux disease and ulcers in the stomach and intestines", according to the FDA.
While regulators around the world continue to look into concerns over potential cancer-causing substances contaminating popular acidity medicine ranitidine, more companies selling the drug in India have made a decision to tread with caution. Ranitidine is a almost Rs 690 crore market in the country, as per pharmaceutical market research firm AIOCD Awacs PharmaTrac. On September 13, the United States regulator stated in a release that it had learned that some ranitidine medicines contained "low levels" of NDMA and it was evaluating whether the substance was present in the drugs at levels that posed a risk to patients.
Leading drugmaker such as Novartis and GSK have recalled their versions of the drug in some markets, and many smaller players, both in the APIs and formulations, are in wait-and-watch mode.
Sanofi, which makes the brand-name drug Zantac, has no plans to halt shipments in the USA. "We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards".
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NDMA and two other cancer-causing substances have also led to widespread recalls of blood pressure and heart medications since previous year.
A number of heartburn medications are being recalled by four drug companies because of a problem with an ingredient during manufacturing.
Data related to N-nitrosodimethylamine impurities is to be provided to the agency in 30 days.
Light said his company's testing simulated how the drug breaks down in the stomach.