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It argues that because generics of liraglutide are already available specifically, Teva's authorised generic version of the drug, which launched in the middle of last year there is "no liraglutide attribute that must be addressed by compounding." Moreover, Novo Nordisk also claims that it is difficult to manufacture liraglutide and "even small changes in the manufacturing process of liraglutide can substantially affect its chemical and physical stability, as well as its impurity profile," and this means that there could be safety concerns with compounding

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Regulatory Frameworks The U.S