"The FDA reported that the levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed amounts found in common foods", says a Sanofi spokesperson.
Strides is engaged in the development, manufacture, and marketing of pharmaceutical products for regulated and emerging markets. And Sanofi, which produces the brand-name Zantac, is not yet making any moves.
But after criticism that it is doubtful whether drugs sold in Korea are safe when the same ones sold in the USA are not, the ministry conducted another investigation of all 269 ranitidine drugs available in Korea and found that they contain excessive NDMA.
Ranitidine is available by prescription and over-the-counter under generic names and other more well known names such as Zantac. The carcinogen is the same one that past year sparked a recall in about 30 countries of millions of blood-pressure pills called angiotensin II receptor blockers.
The companies recalling the drugs include Apotex Inc, Pro Doc Limitee, Sanis Health Inc and Sivem Pharmaceuticals ULC, along with Novartis AG's recall, which was announced last week. The product is a generic version of Vesicare Tablet, 5 mg and 10 mg, of Astellas Pharma US, Inc. Some European regulators have initiated recalls of ranitidine made with active ingredient from Saraca as well.
The Company has temporarily suspended production and distribution of Ranitidine Hydrochloride drug substance.
According to the food and drug safety ministry, seven ranitidine raw materials had NDMA levels reaching as high as 53.50 ppm, significantly exceeding the provisional standard of 0.16 ppm.
Strides Pharma Science on Friday suspended the sale of Ranitidine tablets after it received an information request from the United States health regulator to provide test data related to impurities in the drug.