The Government of Bangladesh has banned production, sale and marketing of Rantidine drug in the country. The Directorate General of Drug(DGDA) Administration announced the move on Thursday (Nov.14).
The two Indian companies that supply the raw materials – Ranitidine hydrochloride – are Saraca Laboratories Limited and Dr Reddy’s Laboratories, according to the DGDA.
Tests run on the raw materials from these companies and the finished product revealed higher than normal levels of N-nitrosodimethylamine (NDMA) purity, which the US Food and Drug Administration says is a “probable human carcinogen, the authority said.
The drug authority has accordingly banned the production, sale and marketing of Ranitidine products made using the materials supplied by the Indian firms.