Samchundang tempers FDA hope as Korea weighs disclosure rules and GMP woes

South Korean generic drug maker Samchundang claims FDA pre-ANDA feedback clears the path for approval of its oral semaglutide generic using only bioequivalence studies, but experts and the FDA's own guidelines suggest the response is directional guidance, not formal approval. The company faces credibility questions given past disclosure controversies and has refused to publicly share the FDA's full response.

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