U.S. FDA Finds Ranitidine Drugs Sold By Strides, Ajanta Pharma Safe To Use
US FDA has set the acceptable daily intake limit for NDMA at 0.32 ppm for Ranitidine, a generic version of Zantac made by Sanofi.
As part of its investigation into a cancer-causing impurity found in a medicine used to cure heartburn and stomach ulcers, the U.S. drug regulator said the generics sold by Strides Pharma Science Ltd. and Ajanta Pharma Ltd. are safe to use.
The U.S. Food and Drug Administration has set the acceptable daily intake limit for N-Nitrosodimethylamine, or NDMA, at 0.096 micrograms or 0.32 parts per million for Ranitidine, a generic version of Zantac made by Sanofi SA, according to the drug regulator’s statement. That’s similar to the levels expected to be found in people consuming common foods like grilled or smoked meat.
While the generic sold by Strides and Ajanta were considered safe, the impurity found in the copycat versions of Dr. Reddy’s Laboratories Ltd. and Aurobindo Pharma Ltd. exceeded the permissible limit. The testing of Ranitidine for injection is still ongoing, the U.S. FDA said. It also recommended recalls to manufacturers with NDMA levels above the acceptable daily intake limit.
The regulator had in September alerted patients and healthcare professionals of the probable carcinogen NDMA—a substance capable of causing cancer—found in the samples of Ranitidine. Following this, drugmakers such as Sanofi and Dr. Reddy’s initiated a voluntary recall of their Zantac and Ranitidine medications in the U.S. and Canada.
Alankar Garude, pharma analyst at Macquarie, in a report said there is now a window of opportunity for Strides Pharma to tap into as it has approval from two regulators—U.S. FDA and Australian Therapeutic Goods Administration—to sell the Ranitidine drug.
Strides Pharma in a media statement said the company intends to provide additional updates in the next few days, including potential recommencement of product distribution by Strides Pharma of Ranitidine based on available test results.
Shares of Srides Pharma, Aurobindo Pharma, Dr. Reddy’s and Ajanta Pharma were trading higher in the range of 1-6 percent during the day. That compares with a 0.86 percent gain in the BSE Healthcare Index.