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Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, lifesciences and pharmaceutical sectors. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.
Requirements relating to biologics’ starting and auxiliary materials, controlling the contamination of biologics, and biologics’ storage and transportation requirements would be replaced with more flexible conditions which apply more broadly.
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