Canadian, European and US regulators have announced their initial reactions to the discovery of N-nitrosodimethylamine, a probable human carcinogen, in ranitidine-based drugs.
NDMA In Ranitidine Risks Rerun Of Sartans Crisis
Regulators in North America and Europe are reacting to the discovery of the impurity NMDA in ranitidine, just over a year after similar impurities in sartan products led to a slew of recalls and withdrawals around the world.

More from Generics
Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?