• October 13, 2023
  • News

Sinopep has obtained FDA First Adequate Letter for Liraglutide

Sinopep received the First Adequate Letter from US FDA on Oct 5, 2023 for the Liraglutide DMF (No. 034104) following FDA’s full scientific review.

What Does It Mean?

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

• Sinopep’s Liraglutide API is adequate and ready for supporting customers’ ANDA approval


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