On October 5, 2023, Sinopep received the First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its Liraglutide Drug Master File (DMF No. 034104), following a full scientific review by the agency.
What Does This Mean?
The FDA has determined that Sinopep’s Liraglutide DMF is adequate for the first time, with no outstanding issues remaining for the review of any referencing Abbreviated New Drug Application (ANDA). Sinopep’s Liraglutide Active Pharmaceutical Ingredient (API) is now fully qualified to support customers in their ANDA submissions and regulatory approvals. This milestone reflects Sinopep’s ongoing commitment to providing high-quality peptide APIs for global pharmaceutical partners.
