Regulatory Guidance

Bangladesh bans ranitidine

Sep 30, 2019

With regulatory bodies in the U.S. and EU investigating the presence of a probable carcinogen in ranitidine, Bangladesh has placed an outright ban on the popular heartburn drug.

Weeks ago, reports surfaced that an online pharmacy had found traces of N-nitrosodimethylamine (NDMA) in several versions of ranitidine, which is also sold under the brand name Zantac. Although the FDA and regulators in the EU are still investigating the matter, Novartis’ Sandoz unit has already recalled its ranitidine product and GlaxoSmithKline, the original brand maker of Zantac, said it is halting global distribution as well.

Now, regulators in Bangladesh have placed a ban on the import of raw materials, production and sales of ranitidine “until further notice” while it conducts its own investigation.

NDMA can reportedly form on its own in ranitidine because it is unstable, and the problem may not be related to manufacturing.

According to Reuters, the Bangladeshi ban will affect two U.S. companies — Beximco Pharmaceuticals and Square Pharmaceuticals — who both produce the medicine.

Read the full Reuters report.