Sinopep Receives FDA's First Adequate Letter for Semaglutide
On December 10, 2023, Sinopep received the First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its Semaglutide Drug Master File (DMF No. 036273), following the FDA’s comprehensive scientific review.
What Does This Mean?
The FDA has deemed Sinopep’s Semaglutide DMF adequate for the first time, with no outstanding issues remaining for the review of referencing Abbreviated New Drug Applications (ANDAs).
This milestone confirms that Sinopep’s Semaglutide Active Pharmaceutical Ingredient (API) meets FDA standards and is now ready to support customers in their ANDA submissions and approvals.
