Retatrutide is an investigational GIP, GLP-1 and glucagon receptor agonist developed by Eli Lilly; it is not an approved drug.
10 listed companies hold an active US Type II Drug Master File for Retatrutide API, based in China (10). 3 have a regulator record of GMP manufacturing, and 1 carries an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Jiangsu peptide CDMO and generic API supplier with large automated SPPS capacity; states it has passed four US FDA inspections. Holds US DMFs for 9 peptide APIs.
Chinese peptide drug manufacturer producing APIs and finished products.
Shanghai bulk peptide maker supplying wholesalers; holds US DMFs for bremelanotide, semaglutide and tirzepatide.
Putian, Fujian peptide API maker founded in 2019 by New Hope and Taiwan's Genovior, focused on GLP-1 APIs. Holds US DMFs for semaglutide and tirzepatide.
Zunyi, Guizhou peptide manufacturer offering development and kg-scale production; holds active US DMFs for tirzepatide and other peptides.
Hangzhou peptide API maker and CDMO founded in 2019, supplying therapeutic and cosmetic peptides. Holds US DMFs for linaclotide, semaglutide and tirzepatide.
Nanjing supplier of insulin and metabolic peptide APIs with technology transfer services; US DMFs for semaglutide and tirzepatide.
Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.
Nantong company founded in 2020 that makes peptides by biosynthesis and offers peptide CMC development. Holds US DMFs for semaglutide and tirzepatide.
Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.
Companies holding active US DMFs for Retatrutide include Sinopep-Allsino Biopharmaceutical Co., Ltd., Hybio Pharmaceutical, El-Peptido (Shanghai) Biopharmaceutical Co., Ltd, Fujian Genohope Biotech Ltd, Guizhou Utide Biotechnology Co., Ltd., Hangzhou Thinheal Pharma-Tech Co., Ltd., Nanjing Cellnuo Biopharmaceutical Co., Ltd, Sichuan Jisheng Biopharmaceutical Co., Ltd, Xiushi Biopharma (Nantong) Co., Ltd. and Harbin Jixianglong Biotech Co., Ltd.. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (10).
Harbin Jixianglong Biotech Co., Ltd. has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.