FDA-Registered Peptide Manufacturers
35 manufacturers, CDMOs, and NDA holders
AbbVie Inc.
NDC Prefix: 0074
Leuprolide (Lupron), Elagolix (Orilissa), Linaclotide (Linzess)
Multiple peptide NDAs
AmbioPharm Inc.
510 CDMOCustom peptides for FDA-approved drugs; Sermorelin, GHRP-2, GHRP-6, PT-141 analogs and others
US-based GMP custom peptide synthesis
Amphastar Pharmaceuticals
NDC Prefix: 76329
Cosyntropin (Cortrosyn), Glucagon, Epinephrine
NDA holder for Cortrosyn
Ascendis Pharma
NDC Prefix: 72548
Lonapegsomatropin (Skytrofa)
NDA holder for weekly GH
AstraZeneca LP
NDC Prefix: 0310
Exenatide (Byetta/Bydureon), Goserelin (Zoladex)
Multiple GLP-1 and GnRH NDAs
Bachem AG
510 ForeignSermorelin, Leuprolide, Octreotide, Exenatide, Gonadorelin
Major GMP peptide manufacturer
CPC Scientific Inc.
510 ManufacturerCustom research and cGMP peptides; BPC-157 analogs, sermorelin and others
US HQ with China manufacturing
Darmerica LLC
Bulk APINDC Prefix: 71052
Semaglutide
US domestic distributor
Eli Lilly Manufacturing S.A.
Tirzepatide, Dulaglutide, Somatropin (Humatrope)
Internal manufacture
EMD Serono (Merck KGaA subsidiary)
NDA HolderNDC Prefix: 44087
Cetrorelix (Cetrotide), Sermorelin (Geref - discontinued), Somatropin (Saizen)
Three peptide NDAs including discontinued sermorelin
Ferring Pharmaceuticals
510 ForeignDegarelix, Gonadorelin, Desmopressin, Oxytocin and others
GnRH peptide specialist
Ferring Pharmaceuticals Inc.
NDA HolderNDC Prefix: 55566
Degarelix (Firmagon), Somatropin (Zomacton)
Two peptide NDAs
Fresenius Kabi USA
510 + 503BManufactures injectable peptides and biologics including oxytocin; operates 503B Fagron Sterile Services Canton MA
Hikma Pharmaceuticals USA
510 + 503BOxytocin injection, GnRH products and compounded peptides
Also registered 503B outsourcing facility; makes injectable generics
Ipsen Biopharmaceuticals Inc.
NDA HolderNDC Prefix: 65483
Lanreotide (Somatuline Depot), Mecasermin (Increlex)
Two peptide NDAs
Ipsen Manufacturing Ireland Ltd.
510 ForeignLanreotide API, Mecasermin
Supplies Ipsen US products
Jazz Pharmaceuticals
NDA HolderNDC Prefix: 68727
Ziconotide (Prialt)
NDA holder for intrathecal ziconotide
Lonza AG
510 ForeignBremelanotide, Setmelanotide, Semaglutide
Large CDMO
Mallinckrodt ARD LLC
NDA HolderNDC Prefix: 63004
ACTH / Corticotropin (H.P. Acthar Gel)
NDA holder for corticotropin gel
Novartis Pharmaceuticals Corp.
NDC Prefix: 0078
Octreotide (Sandostatin), Somatropin (Omnitrope)
NDA holder
Novo Nordisk API A/S
510 ForeignSemaglutide, Liraglutide, Somapacitan
Internal manufacture
Organon USA Inc.
NDA HolderNDC Prefix: 0052
Ganirelix Acetate
NDA holder for ganirelix
Palatin Technologies / AMAG
NDA HolderNDC Prefix: 74255
Bremelanotide (Vyleesi)
NDA holder for bremelanotide
Pfizer Inc.
NDC Prefix: 0025
Nafarelin (Synarel), Somatropin (Genotropin), Gonadorelin (Factrel), Oxytocin
Multiple peptide NDAs
PolyPeptide Group
510 ForeignSemaglutide API, Liraglutide API, Octreotide, Leuprolide, Exenatide, Bivalirudin
Major GMP CDMO
Qingdao Biopeptek Co. Ltd.
Bulk APINDC Prefix: 73212
Liraglutide, Semaglutide, Tirzepatide, Bremelanotide Acetate, Afamelanotide
Multiple GLP-1 bulk powders registered
Radius Health / AbbVie
NDA HolderNDC Prefix: 75824
Abaloparatide (Tymlos)
NDA holder for abaloparatide
Rhythm Pharmaceuticals Inc.
NDC Prefix: 72512
Setmelanotide (Imcivree)
NDA holder
RS Synthesis LLC
510 ManufacturerCustom cGMP peptides; GLP-1 analogs, sermorelin and others
US-based GMP synthesis
Salix Pharmaceuticals
NDA HolderNDC Prefix: 65649
Plecanatide (Trulance)
NDA holder for plecanatide
Sanofi US
NDA HolderNDC Prefix: 0024
Lixisenatide (Adlyxin); also insulin analogs
NDA holder for lixisenatide
Shenzhen PK Biotechnology Co. Ltd.
Bulk APINDC Prefix: 85526
Tesamorelin, Thymosin Beta-4, Thymosin Alpha-1, CJC-1295, Ipamorelin, Hexarelin, Epitalon, Semaglutide, Tirzepatide
Registered bulk API supplier
Sinopep-Allsino Biopharmaceutical Co. Ltd.
Bulk APINDC Prefix: 76177
Semaglutide
Semaglutide bulk powder
Theratechnologies Inc.
NDC Prefix: 68135
Tesamorelin (Egrifta SV)
NDA holder for GHRH analog