12 Oct THE RANITIDINE-CONTAINING MEDICINES THAT ARE REGISTERED AND IN PROCESS
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and 20 January 2020).
This encompassing review was triggered with respect to the potential formation of N-nitrosamine impurities i.e. N-nitrosodimethylamine (NDMA) during the manufacturing process of the above mentioned Active Pharmaceutical Ingredients (APIs). NDMA are classified probable human carcinogens (a substance capable of causing cancer) and mutagens (a substance capable of causing a permanent change in an organism’s genetic make-up), based on the results from laboratory tests.
Although the exact source of the impurity is yet to be determined, it is possible that NDMA may form from the degradation of ranitidine, even after normal storage conditions.
SAHPRA is currently reviewing the levels of NDMA and any other N-nitrosamine impurities in these ranitidine- containing medicines and the measures that can be taken to reduce or eliminate the impurity from future batches produced by companies.
Below are queries from the Pharmaceutical Evaluations & Management unit for your attention and response regarding the ranitidine-containing medicines which are in process or registered. Companies are requested to take note, that the response to these queries should be submitted no later than six (6) months after the date of this notification for registered and all new applications for ranitidine-containing medicines.