Difelikefalin API Manufacturers and Suppliers

Compare the 10 manufacturers holding an active US Drug Master File for Difelikefalin API, with DMF numbers and filing years from the FDA's quarterly DMF list.

Directory listing last reviewed October 2026.

Difelikefalin API manufacturers with a US Drug Master File

10 manufacturers hold an active Type II Drug Master File for DifelikefalinAPI, taken from the FDA's quarterly DMF list; 8 of them are listed in this directory. A DMF lets a drug applicant reference the maker's manufacturing data. It is not an FDA approval. Check each manufacturer against the FDA import alert lists before ordering.

ManufacturerLocationUS DMFFiled
CiplaIndia (Mumbai)377122023
Chunghwa Chemical Synthesis & Biotech (CCSB)Taiwan (New Taipei)385112023
ALP Pharm BeijingChina (Beijing)386452023
MSN LaboratoriesIndia (Hyderabad)405372024
Neuland LabsIndia (Hyderabad)415032025
Hybio PharmaceuticalChina422662025
Sinopep BiopharmaChina438582026
Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd.China447792026

Other Difelikefalin DMF holders

Not yet listed in this directory, so we have not reviewed them. Names as printed in the FDA DMF list.

DMF holderUS DMFFiled
Wisdom Pharmaceutical Co Ltd413412025
Suzhou Yifan Pharmaceutical Co Ltd431952025

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