FDA announces update to NDMA testing recommendations
The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
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The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
The Joint Pharmaceutical Analysis Group held an event in London, discussing the testing of nitrosamine mutagenic impurities in pharmaceutical products and the next steps for manufacturers to take.
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.