CEP & EU-DMF API List
Una lista seleccionada de APIs con documentación CEP y/o EU-DMF indicada en el catálogo actual.
Descargar PDF ↓Una cartera seleccionada de ingredientes farmacéuticos activos para fabricantes de Portugal, España y la Unión Europea.
Solicitar Documentación →Una lista seleccionada de APIs con documentación CEP y/o EU-DMF indicada en el catálogo actual.
Descargar PDF ↓La cartera completa con números CAS y el estado actual de CEP, EU-DMF, US-DMF, GMP, en curso o documentación bajo solicitud.
Descargar PDF ↓Injectable anti-inflammatory & immunosuppressant corticosteroid
Oral / ophthalmic corticosteroid; broad anti-inflammatory use
Injectable / oral corticosteroid; hospital anti-inflammatory
Adrenal insufficiency; systemic & topical corticosteroid
Topical / nasal corticosteroid
Oral-contraceptive estrogen backbone
Luteal support & HRT; largest-volume hormone
Appetite stimulant; oncology cachexia
Anti-androgen; acne, prostate, contraception
Oral progestogen (luteal support); high-value
Non-depolarising neuromuscular blocker (anaesthesia)
Mineralocorticoid antagonist (heart failure, hypertension)
119 resultados
Systemic, injectable & ophthalmic
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | 2392-39-4 | Injectable anti-inflammatory & immunosuppressant corticosteroid | Ph. Eur. | CEPEU-DMFUS-DMF |
| Prednisolone | 50-24-8 | Oral / ophthalmic corticosteroid; broad anti-inflammatory use | Ph. Eur. | CEPEU-DMFUS-DMF |
| Prednisone | 53-03-2 | Oral corticosteroid & immunosuppressant | Ph. Eur. | CEPEU-DMFUS-DMF |
| Methylprednisolone | 83-43-2 | Injectable / oral corticosteroid; hospital anti-inflammatory | Ph. Eur. | CEPEU-DMFUS-DMF |
| Hydrocortisone | 50-23-7 | Adrenal insufficiency; systemic & topical corticosteroid | Ph. Eur. | CEPEU-DMFUS-DMF |
| Prednisone Acetate | 125-10-0 | Corticosteroid ester; oral anti-inflammatory | Ph. Eur. | CEPEU-DMFUS-DMF |
| Dexamethasone | 50-02-2 | High-volume corticosteroid; anti-inflammatory / oncology support | Ph. Eur. | US-DMF |
Topical corticosteroids & anti-androgens
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Betamethasone Valerate | 2152-44-5 | Topical corticosteroid | Ph. Eur. | US-DMF |
| Mometasone Furoate | 83919-23-7 | Topical / nasal corticosteroid | Ph. Eur. | CEP in progress |
| Mometasone Furoate Monohydrate | 141646-00-6 | Aqueous nasal-spray corticosteroid form | In-house | CEP in progress |
| Hydrocortisone Butyrate | 13609-67-1 | Topical corticosteroid ester | Ph. Eur. | CEP in progress |
| Clascoterone | 19608-29-8 | Topical anti-androgen for acne (novel, high-value) | In-house | US-DMF |
Inhaled & nasal therapies
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Tiotropium Bromide | 136310-93-5 | Long-acting anticholinergic bronchodilator (COPD) | Ph. Eur. | US-DMF |
HRT & contraceptive estrogens
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Ethinyl Estradiol | 57-63-6 | Oral-contraceptive estrogen backbone | Ph. Eur. | CEPEU-DMFUS-DMF |
| Estradiol Hemihydrate | 35380-71-3 | Core HRT estrogen (menopause) | Ph. Eur. | CEPEU-DMFUS-DMF |
| Estradiol Valerate | 979-32-8 | HRT & injectable estrogen ester | Ph. Eur. | CEPEU-DMF |
Contraceptive & HRT progestins
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Progesterone | 57-83-0 | Luteal support & HRT; largest-volume hormone | Ph. Eur. | CEPEU-DMFUS-DMF |
| Megestrol Acetate | 595-33-5 | Appetite stimulant; oncology cachexia | Ph. Eur. | CEPEU-DMFUS-DMF |
| Cyproterone Acetate | 427-51-0 | Anti-androgen; acne, prostate, contraception | Ph. Eur. | CEPEU-DMF |
| Norethisterone | 68-22-4 | Contraceptive & HRT progestin | Ph. Eur. | CEPEU-DMF |
| Dydrogesterone | 152-62-5 | Oral progestogen (luteal support); high-value | Ph. Eur. | CEP in progressEU-DMF |
| Levonorgestrel | 797-63-7 | Contraceptive & emergency contraception progestin | Ph. Eur. | CEP in progressUS-DMF |
| Mifepristone | 84371-65-3 | Progesterone-receptor modulator | Ph. Eur. | CEP in progressEU-DMFUS-DMF |
| Medroxyprogesterone Acetate | 71-58-9 | Depot contraceptive; oncology | Ph. Eur. | CEP in progressUS-DMF |
Testosterone & esters
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Testosterone | 58-22-0 | Testosterone-replacement therapy (TRT) | Ph. Eur. | US-DMF |
| Testosterone Undecanoate | 5949-44-0 | Long-acting TRT ester | Ph. Eur. | US-DMF |
| Testosterone Enanthate | 315-37-7 | Core injectable TRT ester | Ph. Eur. | US-DMF |
| Testosterone Cypionate | 58-20-8 | Injectable TRT ester | Ph. Eur. | US-DMF |
| Testosterone Propionate | 57-85-2 | Short-acting TRT ester | Ph. Eur. | US-DMF |
| Testosterone Decanoate | 5721-91-5 | Component of mixed-ester TRT | In-house | US-DMF |
| Testosterone Tridecanoate | 488836-58-4 | Long-acting TRT ester | In-house | US-DMF |
Neuromuscular blockers & reversal
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Rocuronium Bromide | 119302-91-9 | Non-depolarising neuromuscular blocker (anaesthesia) | Ph. Eur. | CEPEU-DMFUS-DMF |
| Vecuronium Bromide | 50700-72-6 | Non-depolarising neuromuscular blocker | Ph. Eur. | US-DMF |
Statins, anticoagulants, antihypertensives
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Eplerenone | 107724-20-9 | Mineralocorticoid antagonist (heart failure, hypertension) | — | CEPEU-DMF |
| Rosuvastatin Calcium | 147098-20-2 | Statin; hypercholesterolaemia | — | Docs on request |
| Atorvastatin Calcium | 134523-03-8 | Statin; hypercholesterolaemia | — | Docs on request |
| Apixaban | 503612-47-3 | Direct factor-Xa anticoagulant | — | Docs on request |
| Rivaroxaban | 366789-02-8 | Direct factor-Xa anticoagulant | — | Docs on request |
DPP-4 & SGLT2 inhibitors
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Sitagliptin Phosphate Monohydrate | 654671-77-9 | DPP-4 inhibitor (type-2 diabetes) | — | Docs on request |
| Linagliptin | 668270-12-0 | DPP-4 inhibitor (type-2 diabetes) | — | Docs on request |
| Alogliptin Benzoate | 850649-62-6 | DPP-4 inhibitor (type-2 diabetes) | — | Docs on request |
| Empagliflozin | 864070-44-0 | SGLT2 inhibitor (type-2 diabetes, HF) | — | Docs on request |
| Dapagliflozin Propanediol | 960404-48-2 | SGLT2 inhibitor (type-2 diabetes, HF, CKD) | — | Docs on request |
| Canagliflozin Monohydrate | 1809403-05-1 | SGLT2 inhibitor (type-2 diabetes) | — | Docs on request |
Antidepressants & neurology
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Escitalopram Oxalate | 219861-08-2 | SSRI antidepressant | — | Docs on request |
| Duloxetine Hydrochloride | 136434-34-9 | SNRI antidepressant / neuropathic pain | — | Docs on request |
| Fingolimod Hydrochloride | 162359-56-0 | Multiple-sclerosis immunomodulator | — | Docs on request |
| Brexanolone | 516-54-1 | Postpartum-depression neuroactive steroid | — | US-DMF |
PPIs & acid blockers
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Esomeprazole Magnesium Dihydrate | 217087-10-0 | Proton-pump inhibitor (GERD) | — | Docs on request |
| Vonoprazan Fumarate | 1260141-27-2 | Potassium-competitive acid blocker | — | Docs on request |
Antibacterial, antifungal, antimalarial
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Moxifloxacin Hydrochloride | 186826-86-8 | Fourth-generation fluoroquinolone antibacterial | — | Docs on request |
| Isavuconazonium Sulfate | 946075-13-4 | Broad-spectrum systemic antifungal | — | Docs on request |
| Mefloquine Hydrochloride | 51773-92-3 | Antimalarial | — | Docs on request |
Targeted kinase & pathway inhibitors
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Palbociclib | 571190-30-2 | CDK4/6 inhibitor (breast cancer) | — | Docs on request |
| Ribociclib Succinate | 1374639-75-4 | CDK4/6 inhibitor (breast cancer) | — | Docs on request |
| Abemaciclib | 1231929-97-7 | CDK4/6 inhibitor (breast cancer) | — | Docs on request |
| Venetoclax | 1257044-40-8 | BCL-2 inhibitor (haematological malignancy) | — | Docs on request |
| Niraparib Tosylate | 1038915-73-9 | PARP inhibitor (ovarian cancer) | — | Docs on request |
| Axitinib | 319460-85-0 | VEGFR tyrosine-kinase inhibitor (RCC) | — | Docs on request |
| Lenvatinib Mesilate | 857890-39-2 | Multi-kinase inhibitor (thyroid, HCC) | — | Docs on request |
| Sorafenib Tosylate | 475207-59-1 | Multi-kinase inhibitor (HCC, RCC) | — | Docs on request |
| Regorafenib | 755037-03-7 | Multi-kinase inhibitor (colorectal cancer) | — | Docs on request |
| Alectinib Hydrochloride | 1256589-74-8 | ALK inhibitor (NSCLC) | — | Docs on request |
| Darolutamide | 1297538-32-9 | Androgen-receptor inhibitor (prostate cancer) | — | Docs on request |
| Relugolix | 737789-87-6 | GnRH-receptor antagonist (prostate cancer) | — | Docs on request |
| Eltrombopag Olamine | 496775-62-3 | Thrombopoietin-receptor agonist | — | Docs on request |
JAK inhibitors & immunomodulators
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Upadacitinib | 1310726-60-3 | JAK inhibitor (rheumatoid arthritis, IBD) | — | Docs on request |
| Baricitinib | 1187594-09-7 | JAK inhibitor (rheumatoid arthritis) | — | Docs on request |
| Tofacitinib Citrate | 540737-29-9 | JAK inhibitor (rheumatoid arthritis) | — | Docs on request |
| Ruxolitinib Phosphate | 1092939-17-7 | JAK1/2 inhibitor (myelofibrosis) | — | Docs on request |
CFTR modulators, CGRP, urology
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Tadalafil | 171596-29-5 | PDE5 inhibitor (ED, BPH, PAH) | — | Docs on request |
| Solifenacin | 242478-37-1 | Muscarinic antagonist (overactive bladder) | — | Docs on request |
| Rimegepant Sulfate | 1374024-48-2 | CGRP-receptor antagonist (migraine) | — | Docs on request |
| Ivacaftor | 873054-44-5 | CFTR potentiator (cystic fibrosis) | — | Docs on request |
| Tezacaftor | 1152311-62-0 | CFTR corrector (cystic fibrosis) | — | Docs on request |
| Lumacaftor | 936727-05-8 | CFTR corrector (cystic fibrosis) | — | Docs on request |
| Elexacaftor | 2216712-66-0 | CFTR corrector (cystic fibrosis) | — | Docs on request |
GLP-1 & specialty peptides
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Semaglutide | 910463-68-2 | GLP-1 agonist (type-2 diabetes, weight management) | — | Docs on request |
| Tirzepatide | 2023788-19-2 | GIP/GLP-1 co-agonist (diabetes, weight management) | — | Docs on request |
| Liraglutide | 204656-20-2 | GLP-1 agonist (diabetes, weight management) | — | Docs on request |
| Exenatide | 141732-76-5 | GLP-1 agonist (type-2 diabetes) | — | Docs on request |
| Octreotide Acetate | 83150-76-9 | Somatostatin analogue (acromegaly, NET) | — | Docs on request |
| Lanreotide | 108736-35-2 | Somatostatin analogue (acromegaly, NET) | — | Docs on request |
| Teriparatide Acetate | 52232-67-4 | PTH analogue (osteoporosis) | — | Docs on request |
| Abaloparatide Acetate | 247062-33-5 | PTHrP analogue (osteoporosis) | — | Docs on request |
| Bivalirudin | 128270-60-0 | Direct thrombin inhibitor (anticoagulant) | — | Docs on request |
| Eptifibatide | 188627-80-7 | GP IIb/IIIa antagonist (antiplatelet) | — | Docs on request |
| Terlipressin Acetate | 14636-12-5 | Vasopressin analogue (hepatorenal syndrome) | — | Docs on request |
| Ganirelix Acetate | 123246-29-7 | GnRH antagonist (assisted reproduction) | — | Docs on request |
| Icatibant Acetate | 138614-30-9 | Bradykinin B2 antagonist (angioedema) | — | Docs on request |
| Etelcalcetide | 1262780-97-1 | Calcimimetic (secondary hyperparathyroidism) | — | Docs on request |
| Linaclotide | 851199-59-2 | GC-C agonist (IBS-C, chronic constipation) | — | Docs on request |
| Atosiban Acetate | 90779-69-4 | Oxytocin antagonist (preterm labour) | — | Docs on request |
| Carbetocin Acetate | 37025-55-1 | Oxytocin analogue (postpartum haemorrhage) | — | Docs on request |
| Thymosin Alpha-1 | 62304-98-7 | Immunomodulator | — | Docs on request |
| Ziconotide Acetate | 107452-89-1 | N-type calcium-channel blocker (chronic pain) | — | Docs on request |
Ph.Eur./USP pharmaceutical grade
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| Glycine | 56-40-6 | — | Ph. Eur. / USP | Docs on request |
| L-Alanine | 56-41-7 | — | Ph. Eur. / USP | Docs on request |
| L-Aspartic Acid | 56-84-8 | — | Ph. Eur. / USP | Docs on request |
| L-Glutamic Acid | 56-86-0 | — | Ph. Eur. / USP | Docs on request |
| L-Isoleucine | 73-32-5 | — | Ph. Eur. / USP | Docs on request |
| L-Leucine | 61-90-5 | — | Ph. Eur. / USP | Docs on request |
| L-Lysine Hydrochloride | 657-27-2 | — | Ph. Eur. / USP | Docs on request |
| L-Lysine Acetate | 57282-49-2 | — | Ph. Eur. / USP | Docs on request |
| L-Methionine | 63-68-3 | — | Ph. Eur. / USP | Docs on request |
| L-Phenylalanine | 63-91-2 | — | Ph. Eur. / USP | Docs on request |
| L-Serine | 56-45-1 | — | Ph. Eur. / USP | Docs on request |
| L-Threonine | 72-19-5 | — | Ph. Eur. / USP | Docs on request |
| L-Tryptophan | 73-22-3 | — | Ph. Eur. / USP | Docs on request |
| L-Tyrosine | 60-18-4 | — | Ph. Eur. / USP | Docs on request |
Anti-ageing & regenerative actives
| API | N.º CAS | Aplicación Terapéutica | Norma / Grado | Documentación |
|---|---|---|---|---|
| GHK-Cu (Tripeptide-1 Copper) | 89030-95-5 | Anti-ageing skin-conditioning peptide | — | Docs on request |
| Polydeoxyribonucleotide (PDRN) | 100403-24-5 | Tissue-regeneration activator | — | Docs on request |
| L-(+)-Ergothioneine | 497-30-3 | Antioxidant anti-ageing active | — | Docs on request |
| β-Nicotinamide Mononucleotide (NMN) | 1094-61-7 | NAD+ precursor / anti-ageing | — | Docs on request |
| β-Nicotinamide Adenine Dinucleotide (NAD) | 53-84-9 | Cellular-energy anti-ageing active | — | Docs on request |
| Nicotinamide Riboside Chloride (NRC) | 23111-00-4 | NAD+ precursor | — | Docs on request |
| Nonapeptide-1 | 158563-45-2 | Skin-brightening peptide | — | Docs on request |
| Palmitoyl Tripeptide-5 | 623172-56-5 | Anti-ageing peptide | — | Docs on request |
| Acetyl Hexapeptide-8 (Argireline) | 616204-22-9 | Expression-line peptide | — | Docs on request |
La documentación técnica y regulatoria se evalúa producto por producto y se confirma según el mercado, forma farmacéutica y proyecto antes del suministro.
El estado final, validez, cobertura del centro de fabricación y alcance regulatorio deben verificarse durante la cualificación. La disponibilidad depende del proyecto, regulación, propiedad intelectual, territorio, documentación y condiciones comerciales.