Sinopep has obtained FDA First Adequate Letter for Semaglutide

Sinopep received the First Adequate Letter from US FDA on Dec. 10, 2023 for the Semaglutide DMF (No. 036273) following FDA’s full scientific review.

What Does It Mean?

Sinopep’s Semaglutide DMF becomes adequate for the first time and there are no open issues related to review of the referencing ANDA.

Sinopep’s Semaglutide API is adequate and ready for supporting customers’ ANDA approval.

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