Difelikefalin is a peripheral kappa opioid receptor agonist for pruritus in dialysis patients (Korsuva).
8 listed companies hold an active US Type II Drug Master File for Difelikefalin API, based in China (4), India (3), Taiwan (1). 6 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.
Taiwanese API maker founded in 1964, trading as Cenra API Solutions, offering CMO/CDMO services. Holds US DMFs for difelikefalin, plecanatide and setmelanotide.
Hyderabad-based MSN Group entity holding US DMFs for 11 peptide APIs, including semaglutide and tirzepatide. MSN runs 27 plants in India, the USA and Indonesia.
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.
Indian API manufacturer and CDMO with a peptide synthesis platform.
Beijing API company, founded 2006, that holds DMFs and has its APIs made in partner facilities under its own quality control. Holds US DMFs for 13 peptide APIs.
Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.
Mumbai drug maker incorporated in 1935 with plants in India and the USA. Holds US DMFs for difelikefalin, icatibant and terlipressin. Pithampur FDA warning letter still open.
Companies holding active US DMFs for Difelikefalin include Chunghwa Chemical Synthesis & Biotech Co., Ltd. (Cenra API Solutions), MSN Life Sciences Private Ltd (MSN Group), Sinopep-Allsino Biopharmaceutical Co., Ltd., Hybio Pharmaceutical, Neuland Laboratories, ALP Pharm Beijing Co., Ltd., Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd. and Cipla Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (4), India (3), Taiwan (1).
Cipla 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.