PRODUCT CATALOGUE

Active Pharmaceutical Ingredients

Regulatory confidence with reliable supply and European focus

A curated portfolio of active pharmaceutical ingredients for pharmaceutical manufacturers across Portugal, Spain and the European Union.

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119ingredients

18therapeutic categories

✓Project-specific documentation review

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Product documentation at a glance

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CEP · EU-DMF

CEP & EU-DMF API List

A focused list of APIs with CEP and/or EU-DMF documentation indicated in the current catalogue.

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CEP · EU-DMF · US-DMF · GMP · DOCS ON REQUEST

Regulatory API Portfolio Catalog

The complete portfolio with CAS numbers and current CEP, EU-DMF, US-DMF, GMP, in-progress or documentation-on-request status.

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FEATURED ACTIVE INGREDIENTS

Priority molecules in the supplied catalogue

Corticosteroids & Anti-inflammatory

Dexamethasone Sodium Phosphate

Injectable anti-inflammatory & immunosuppressant corticosteroid

CEPEU-DMFUS-DMF

Corticosteroids & Anti-inflammatory

Prednisolone

Oral / ophthalmic corticosteroid; broad anti-inflammatory use

CEPEU-DMFUS-DMF

Corticosteroids & Anti-inflammatory

Methylprednisolone

Injectable / oral corticosteroid; hospital anti-inflammatory

CEPEU-DMFUS-DMF

Corticosteroids & Anti-inflammatory

Hydrocortisone

Adrenal insufficiency; systemic & topical corticosteroid

CEPEU-DMFUS-DMF

Dermatology

Mometasone Furoate

Topical / nasal corticosteroid

CEP in progress

Sex Hormones — Estrogens

Ethinyl Estradiol

Oral-contraceptive estrogen backbone

CEPEU-DMFUS-DMF

Sex Hormones — Progestogens

Progesterone

Luteal support & HRT; largest-volume hormone

CEPEU-DMFUS-DMF

Sex Hormones — Progestogens

Megestrol Acetate

Appetite stimulant; oncology cachexia

CEPEU-DMFUS-DMF

Sex Hormones — Progestogens

Cyproterone Acetate

Anti-androgen; acne, prostate, contraception

CEPEU-DMF

Sex Hormones — Progestogens

Dydrogesterone

Oral progestogen (luteal support); high-value

CEP in progressEU-DMF

Muscle Relaxants

Rocuronium Bromide

Non-depolarising neuromuscular blocker (anaesthesia)

CEPEU-DMFUS-DMF

Cardiovascular & Coagulation

Eplerenone

Mineralocorticoid antagonist (heart failure, hypertension)

CEPEU-DMF

FULL PORTFOLIO

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119 results

Corticosteroids & Anti-inflammatory

Systemic, injectable & ophthalmic

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Dermatology

Topical corticosteroids & anti-androgens

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Respiratory & ENT

Inhaled & nasal therapies

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
Tiotropium Bromide	136310-93-5	Long-acting anticholinergic bronchodilator (COPD)	Ph. Eur.	US-DMF

Sex Hormones — Estrogens

HRT & contraceptive estrogens

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Sex Hormones — Progestogens

Contraceptive & HRT progestins

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Androgens / TRT

Testosterone & esters

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Muscle Relaxants

Neuromuscular blockers & reversal

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Cardiovascular & Coagulation

Statins, anticoagulants, antihypertensives

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Diabetes & Metabolic

DPP-4 & SGLT2 inhibitors

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Central Nervous System

Antidepressants & neurology

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Gastrointestinal

PPIs & acid blockers

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Anti-infective

Antibacterial, antifungal, antimalarial

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Oncology & Haematology

Targeted kinase & pathway inhibitors

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Immunology & Inflammation

JAK inhibitors & immunomodulators

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Specialty & Rare Disease

CFTR modulators, CGRP, urology

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Peptide Therapeutics

GLP-1 & specialty peptides

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Amino Acids

Ph.Eur./USP pharmaceutical grade

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

Cosmetic & Nutraceutical Actives

Anti-ageing & regenerative actives

API	CAS No.	Therapeutic Application	Standard / Grade	Documentation
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

REGULATORY & QUALITY FRAMEWORK

Documentation, assessed product by product

Regulatory and technical documentation is assessed product by product and confirmed against the intended market, dosage form and customer project before supply.

CEPEU-DMFUS-DMFCEP in progressDocs on request

Final status, validity, manufacturing site coverage and regulatory scope must be verified during project qualification. Availability is subject to project qualification, applicable regulation, intellectual property, destination territory, documentation and commercial availability.

A–Z INDEX

All ingredients

Abaloparatide Acetate Abemaciclib Acetyl Hexapeptide-8 (Argireline)Alectinib Hydrochloride Alogliptin Benzoate Apixaban Atorvastatin Calcium Atosiban Acetate Axitinib Baricitinib Betamethasone Valerate Bivalirudin Brexanolone Canagliflozin Monohydrate Carbetocin Acetate Clascoterone Cyproterone Acetate Dapagliflozin Propanediol Darolutamide Dexamethasone Dexamethasone Sodium Phosphate Duloxetine Hydrochloride Dydrogesterone Elexacaftor Eltrombopag Olamine Empagliflozin Eplerenone Eptifibatide Escitalopram Oxalate Esomeprazole Magnesium Dihydrate Estradiol Hemihydrate Estradiol Valerate Etelcalcetide Ethinyl Estradiol Exenatide Fingolimod Hydrochloride Ganirelix Acetate GHK-Cu (Tripeptide-1 Copper)Glycine Hydrocortisone Hydrocortisone Butyrate Icatibant Acetate Isavuconazonium Sulfate Ivacaftor L-(+)-Ergothioneine L-Alanine L-Aspartic Acid L-Glutamic Acid L-Isoleucine L-Leucine L-Lysine Acetate L-Lysine Hydrochloride L-Methionine L-Phenylalanine L-Serine L-Threonine L-Tryptophan L-Tyrosine Lanreotide Lenvatinib Mesilate Levonorgestrel Linaclotide Linagliptin Liraglutide Lumacaftor Medroxyprogesterone Acetate Mefloquine Hydrochloride Megestrol Acetate Methylprednisolone Mifepristone Mometasone Furoate Mometasone Furoate Monohydrate Moxifloxacin Hydrochloride Nicotinamide Riboside Chloride (NRC)Niraparib Tosylate Nonapeptide-1 Norethisterone Octreotide Acetate Palbociclib Palmitoyl Tripeptide-5 Polydeoxyribonucleotide (PDRN)Prednisolone Prednisone Prednisone Acetate Progesterone Regorafenib Relugolix Ribociclib Succinate Rimegepant Sulfate Rivaroxaban Rocuronium Bromide Rosuvastatin Calcium Ruxolitinib Phosphate Semaglutide Sitagliptin Phosphate Monohydrate Solifenacin Sorafenib Tosylate Tadalafil Teriparatide Acetate Terlipressin Acetate Testosterone Testosterone Cypionate Testosterone Decanoate Testosterone Enanthate Testosterone Propionate Testosterone Tridecanoate Testosterone Undecanoate Tezacaftor Thymosin Alpha-1 Tiotropium Bromide Tirzepatide Tofacitinib Citrate Upadacitinib Vecuronium Bromide Venetoclax Vonoprazan Fumarate Ziconotide Acetate β-Nicotinamide Adenine Dinucleotide (NAD)β-Nicotinamide Mononucleotide (NMN)