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Classification of Polypeptide API
US-DMF LIST
| US-DMF LIST–Polypeptide API | ||
|---|---|---|
| Product Name | US-DMF No. | WC |
| Bivalirudin | DMF 25531 | YES |
| Eptifibatide | DMF 27651 | YES |
| Liraglutide | DMF 29302 | YES |
| Icatibant Acetate | DMF 28496 | YES |
| Octreotide Acetate | DMF 30249 | YES |
| Teriparatide Acetate | DMF 32144 | |
| Ziconotide Acetate | DMF 33139 | |
| * | * |
Chinese cGMP APIs
| Chinese cGMP APIs–Polypeptide API | ||
|---|---|---|
| Product Name | GMP Certificate No. | WC |
| Levosimendan | SC20120022 | |
| Thymosin alpha1 | SC20140047 | |
| Enfuvirtide | SC20140098 | |
| Octreotide Acetate | SC20150121 | YES |
| Somatostatin | SC20150121 | |
| Thymopentin | SC20150121 | |
| Carbetocin | SC20160013 | |
| Atosiban | SC20170065 |
Research Polypeptide APIs for Regulatory Market
| Research Polypeptide APIs for Regulatory Market | |
|---|---|
| Product Name | US-DMF Time Point |
| Linaclotide | Before the end of 2019 |
| Ganirelix | Before the end of 2019 |
| Degarelix | Before the end of 2020 |
| Exenatide | Before the end of 2021 |
| Teduglutide | Before the end of 2021 |
| Cetrorelix | Before the end of 2021 |
| Semaglutide | Before the end of 2022 |
Mexico Registered APIs –Polypeptide APIs
| Mexico Registered APIs –Polypeptide API | |
|---|---|
| Product Name | GMP Certificate No. |
| Levosimendan | SC20120022 |
| Enfuvirtide | SC20140098 |
| Bivalirudin | DMF 25531 |
| Eptifibatide | DMF 27651 |
| Liraglutide | DMF 29302 |
| Icatibant Acetate | DMF 28496 |
| Octreotide Acetate | DMF 30249SC20150121 |
| Peptide API | |
|---|---|
| Product name | Serial number |
| Alarelin Acetate | 79561-22-1 |
| Angiotensin Acetate | 20071-00-5 |
| Argipressin Acetate | 113-79-1 |
| Atosiban Acetate | 90779-69-4 |
| Trifluoro Acetate | 128270-60-0 |
| Cetrorelix Acetate | 120287-85-6 |
| Deslorelin Acetate | 57773-65-6 |
| Desmopressin Acetate | 16789-98-3 |
| Elcatonin Acetate | 57014-02-5 |
| Enfuvirtide Acetate | 159519-65-0 |
| Eptifibatide Acetate | 148031-34-9 |
| Exenatide Acetate | 141732-76-5 |
| GLP-1(7-36) | 107444-51-9 |
| Glucagon Acetate | 16941-32-5 |
| Gonadorelin Acetate | 71447-49-9 |
| Leuprorelin Acetate | 53714-56-0 |
| Lysipressin Acetate | 50-57-7 |
| Nesiritide Acetate | 114471-18-0 |
| Octreotide Acetate | 83150-76-9 |
| Oxytocin Acetate | 50-56-6 |
| Pramlintide Acetate | 196078-30-5 |
| Salcitonin Acetate | 47931-85-1 |
| Secretin Acetate | 17034-35-4 |
| Sermorelin Acetate | 86168-78-7 |
| Somatostatin Acetate | 38916-34-6 |
| Teriparatide Acetate | 52232-67-4 |
| Terlipressin Acetate | 14636-12-5 |
| Tetracosactide Acetate | 16960-16-0 |
| Thymopentin | 69558-55-0 |
| Thymosin α1 Acetate | 62304-98-7 |
| Triptorelin Acetate | 57773-63-4 |
| Ziconotide Acetate | 107452-89-1 |
| CJC-1295 | |
| Buserelin Acetate | 68630-75-1 |
| MOG (35-55) | 149635-73-4 |
| Ghrelin(Human) Acetate | 304853-26-7 |
Other Polypeptide APIs Products
peptide synthesis companies
| Polypeptide APIs Products |
| US-DMF LIST |
| Beauty peptides |
| Chinese cGMP APIs |
| Mexico Registered APIs |
| Research Peptide APIs for Regulatory Market |
| Polypeptide Preparation |
| Kaijie bio medicine Peptide APIs |
2021 polypeptide product list of BIOFDA