The US Food and Drug Administration in 1 September guidance advises manufacturers to assess the nitrosamine impurity risks associated with all chemically synthesized active pharmaceutical ingredients and all approved or marketed drug products that contain those APIs or other sources of nitrosamines by 1 March 2021.
US FDA Expectations For Removing Nitrosamines From All APIs, Drug Products
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.
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