API Product portfolio
Axplora, global leader in API supply
Axplora offers a comprehensive portfolio of small molecule APIs. We are a global leader in manufacturing non-sterile and sterile steroids as well as a leading supplier of specialty API products, including 5-ASA, UDCA, High Potent Substances (HPS) and anticancer drugs.
Interested in speaking with Axplora experts about your generic drug development needs? Simply click here
Table key:
# available for reference
* non-animal and non-human origin
** submission under preparation
CHE = Chennai, India / CSR = Chasse-sur-Rhône, France / GRO = Gropello, Italy / LEV = Leverkusen, Germany / MRX = Mourenx, France / RAU = Raubling, Germany / VIZ = Vizag, India
Steroids
| Active Ingredient CAS Number | Therapeutic Areas | Monograph | Available Grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|
| 16α-Hydroxyprednisolone | Advanced Intermediate | INTERNAL SPEC. | Standard | EU DMF US DMF** | GRO |
| Amcinonide 51022-69-6 | Dermatologic | USP | Micronized | EU DMF | GRO |
| Beclomethasone Dipropionate 5534-09-8 | Respiratory | PH.EUR. USP | Standard Micronized | US DMF# CEP SAUDI DMF CN DMF | GRO |
| Beclomethasone Dipropionate Monohydrate 77011-63-3 | Respiratory | PH.EUR. USP | Micronized | EU DMF US DMF | GRO |
| Betamethasone base | Advanced Intermediate | PH.EUR. US DMF | Standard | EU DMF US DMF | GRO |
| Betamethasone Dipropionate 5593-20-4 | Dermatologic | PH.EUR. USP | Micronized | US DMF# CEP SAUDI DMF | GRO |
| Betamethasone Valerate 2152-44-5 | Dermatologic | PH.EUR. USP | Micronized | US DMF# JP DMF CEP | GRO |
| Brexanolone 516-54-1 | CNS | INTERNAL SPEC. | Standard | US-DMF** | GRO |
| Budesonide 51333-22-3 | Respiratory Gastro-Intestinal | PH.EUR. USP JP | Micronized | EU DMF US DMF# CEP JP DMF SAUDI DMF | GRO |
| Clascoterone 19608-29-8 | Dermatologic | INTERNAL SPEC. | Standard | DMF** | GRO |
| Chlormadinone Acetate 302-22-7 | Contraceptive | PH.EUR. JP | Micronized | JP DMF CEP | GRO |
| Clobetasol Propionate 25122-46-7 | Dermatologic | PH.EUR. USP | Micronized | US DMF# JP DMF CEP SAUDI DMF | GRO |
| Clobetasone Butyrate 25122-57-0 | Dermatologic | PH.EUR. | Micronized | EU DMF | GRO |
| Clocortolone Pivalate 34097-16-0 | Dermatologic | USP | Micronized | EU DMF US DMF | GRO |
| Cyproterone Acetate 427-51-0 | Anti-Androgen | PH.EUR. | Micronized | US DMF CEP | GRO |
| Delmadinone Acetate 13698-449-2 | Anti-Androgen (Veterinary) | INTERNAL SPEC. | Micronized | EU DMF | GRO |
| Desonide 638-94-8 | Dermatologic | USP | Micronized | EU DMF US DMF# CN DMF | GRO |
| Desonide Sodium Phosphate 94087-98-6 | Ophthalmic | INTERNAL SPEC. | Standard | EU DMF | GRO |
| Desoximetasone 382-67-2 | Dermatologic Ophthalmic | USP | Micronized | EU DMF US DMF# | GRO |
| Dexametasone 50-02-2 | Anti-Inflammatory | USP | Micronized | EU DMF US DMF# | GRO |
| Dexametasone Sodium Phosphate 312-93-6 | Anti-Inflammatory | PH.Eur. USP | Standard | EU DMF | GRO |
| Diflorasone Diacetate 2557-49-5 | Dermatologic | JP USP | Standard | EU DMF | GRO |
| Diflucortolone Valerate 59198-70-8 | Dermatologic | BP JP | Micronized | EU DMF JP DMF | GRO |
| Difluprednate 23674-86-4 | Ophthalmic | INTERNAL SPEC. | Micronized | EU DMF US DMF# JP DMF | GRO |
| Exemestane 107868-30-4 | Anti-Cancer | PH.EUR. USP | Micronized | US DMF# CEP | GRO |
| Fludrocortisone Acetate 514-36-3 | Adrenocortical Insufficiency | PH.EUR. USP | Micronized | US DMF CEP | GRO |
| Fludrocortisone Base 127-31-1 | Anti-Inflammatory | INTERNAL SPEC. | Micronized | EU DMF | GRO |
| Flumethasone 2135-17-3 | Advanced Intermediate | INTERNAL SPEC. | Micronized | EU DMF US DMF | GRO |
| Flumethasone Pivalate 2002-29-1 | Dermatologic | PH.EUR. USP | Micronized | EU DMF | GRO |
| Flunisolide Anhydrous 3385-03-3 | Anti-Asthmatic | USP | Micronized | EU DMF US DMF# | GRO |
| Flunisolide Hemihydrate 77326-96-6 | Respiratory | USP | Micronized | EU DMF US DMF# | GRO |
| Fluocinonide 356-12-7 | Dermatologic | USP BP | Micronized | EU DMF US DMF# JP DMF | GRO |
| Fluocinolone Acetonide 67-73-2 | Dermatologic | PH.EUR. USP | Micronized | US DMF# JP DMF CEP CN DMF SAUDI DMF | GRO |
| Fluocortolone hexanoate (Caproate) 303-40-2 | Dermatologic | PH.EUR. | Micronized | EU DMF | GRO |
| Fluocortolone pivalate 29205-06-9 | Dermatologic | PH.EUR. | Micronized | EU DMF | GRO |
| Fluorometholone Base 426-13-1 | Ophthalmic | USP JP | Micronized | EU DMF JP DMF US DMF | GRO |
| Fluprednidene Acetate 1255-35-2 | Dermatologic | INTERNAL SPEC. | Standard | EU DMF | GRO |
| Flurandrenolide 1524-88-5 | Dermatologic | USP | Micronized | EU DMF US DMF# JP DMF | GRO |
| Fluticasone Furoate 397864-44-7 | Respiratory | INTERNAL SPEC. | Micronized | EU DMF | GRO |
| Fluticasone Propionate 80474-14-2 | Respiratory | PH.EUR. USP | Micronized | US DMF# CEP | GRO |
| Fulvestrant 129453-61-8 | Anti-Cancer | PH.EUR. USP | Standard | US DMF# CEP | GRO |
| Halcinonide 3093-35-4 | Dermatologic | USP | Micronized | EU DMF US DMF# CN DMF | GRO |
| Halometasone Monohydrate 50629-82-8 | Dermatologic | INTERNAL SPEC. | Micronized | EU DMF | GRO |
| Hydrocortisone Acetate 50-03-3 | Dermatologic Ophthalmic | PH.EUR. USP | Micronized | CEP** | GRO |
| Hydrocortisone hydrogen succinate 2203-97-6 | Anti-Inflammatory | PH.EUR. USP | Standard | EU DMF US DMF | GRO |
| Loteprednol Etabonate 82034-46-6 | Ophthalmic | INTERNAL SPEC. | Standard | EU DMF US DMF# | GRO |
| Medroxyprogesterone Acetate 71-58-9 | Contraceptive | PH.EUR. USP | Micronized | US DMF CEP JP DMF | GRO |
| Megestrol Acetate 595-33-5 | Anti-Cancer | PH.EUR. USP | Micronized | US DMF# CEP | GRO |
| Methylprednisolone Aceponate 86401-95-8 | Topical/Dermatologic | INTERNAL SPEC. | Standard Micronized | EU DMF | GRO |
| Methyltestosterone 58-18-4 | Anabolic- Androgenic | PH.EUR. USP | Micronized | EU DMF US DMF# | GRO |
| Mometasone Furoate 83919-23-7 | Respiratory- Dermatologic | PH.EUR. USP | Micronized | US DMF# CEP SAUDI DMF | GRO |
| Osaterone Acetate 105149-04-0 | Anti-Androgen (Veterinary) | JP | Micronized | EU DMF | GRO |
| Paramethasone Acetate 1597-82-6 | Dermatologic | INTERNAL SPEC. | Micronized | EU DMF | GRO |
| Prednisolone Acetate 52-21-1 | Dermatologic | PH.EUR. USP | Standard | CEP | GRO |
| Prednisolone Hexanoate (Caproate) 69164-69-8 | Dermatologic | INTERNAL SPEC. | Standard | EU DMF | GRO |
| Prednisolone Valerate Acetate 72064-79-0 | Dermatologic | INTERNAL SPEC. | Micronized | EU DMF JP DMF | GRO |
| Prednisolone Sodium Metasulfobenzoate 3694-41-5 | Anti-Inflammatory | INTERNAL SPEC. | Standard | EU DMF | GRO |
| Triamcinolone 124-94-7 | Dermatologic Ophthalmic | PH.EUR. USP | Micronized | EU DMF | GRO |
| Triamcinolone Acetonide 76-25-5 | Dermatologic Ophthalmic | PH.EUR. USP | Micronized | US DMF# CEP | GRO |
| Triamcinolone Diacetate 67-78-7 | Dermatologic Ophthalmic | USP | Micronized | EU DMF US DMF | GRO |
| Triamcinolone Hexacetonide 5611-51-8 | Anti-Inflammatory | PH.EUR. USP | Standard Micronized | US DMF CEP | GRO |
Sterile Steroids
| Active Ingredient CAS Number | Therapeutic Areas | Monograph | Available Grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|
| Beclomethasone Dipropionate 5534-09-8 | Respiratory | PH.EUR. USP | Micronized | EU DMF | GRO |
| Budesonide 51333-22-3 | Respiratory | PH.EUR. USP | Micronized | EU DMF US DMF | GRO |
| Hydrocortisone Acetate 50-03-3 | Ophthalmic | PH.EUR. USP | Micronized | EU DMF | GRO |
| Loteprednol Etabonate 82034-46-6 | Ophthalmic | INTERNAL SPEC. | Micronized | EU DMF US DMF | GRO |
| Medroxyprogesterone Acetate (WHO Pre-Qualified) 71-58-9 | Contraceptive | PH.EUR. USP | Micronized | US DMF# WHO DMF | GRO |
| Methylprednisolone Acetate 53-36-1 | Injectable Anti-Inflammatory | PH.EUR. USP | Micronized | EU DMF US DMF# CEP* | GRO |
| Prednisolone Acetate 52-21-1 | Ophthalmic Injectable Anti-Inflammatory | PH.EUR. USP | Micronized | US DMF# CEP | GRO |
| Prednisolone Base 50-24-8 | Anti-Inflammatory (Veterinary) | PH.EUR. USP | Micronized | EU DMF | GRO |
| Triamcinolone Acetonide 76-25-5 | Injectable Anti-Inflammatory | PH.EUR. USP | Micronized | EU DMF US DMF# JP DMF CEP* | GRO |
High Potent Substances
| Active Ingredient CAS Number | Therapeutic Areas | Monograph | Available Grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|
| Cannabidiol (CBD, Synthetic) 13956-29-1 | Various | DAC (German Drug Codex) | Standard | EU DMF US DMF | GRO |
| Formoterol Fumarate Dihydrate 183814-30-4 | Respiratory | PH.EUR. USP | Micronized | US DMF CEP | GRO |
| Tirofiban Hydrochloride Monohydrate 150915-40-5 | Cardiovascular | INTERNAL SPEC. | Standard | EU DMF US DMF | GRO |
| Salmeterol Xinafoate 94749-08-3 | Respiratory | INTERNAL SPEC. | Micronized | CEP | GRO |
Cytotoxics
Specialty Products
| Active Ingredient CAS Number | Therapeutic Areas | Monograph | Available Grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|
| Balsalazide Disodium 150399-21-6 | Anti-Inflammatory Gastrointestinal | USP | Standard Fine Dense | US DMF# EU DMF | RAU CHE |
| Celecoxib (Form III) 169590-42-5 | NSAID | PH.EUR. USP | Fine Micronized | CEP EU DMF US DMF# CA DMF | VIZ |
| Esmolol hydrochloride 81161-17-3 | Anti-Arrhythmic | API QUALITY | Standard | US DMF CA DMF EU DMF | CSR |
| Etoricoxib (Form I) 202409-33-4 | Arthritis | API QUALITY | Standard Micronized | EU DMF | VIZ |
| Indapamide 26807-65-8 | Anti-Hypertensive Diuretic | PH.EUR. | Standard Micronized | CEP EU DMF | VIZ |
| L-Cysteine HCL Monohydrate 7048-04-6 | Various | PH.EUR. | Standard | CEP EU DMF | CHE |
| L-Cysteine HCl Anhydrous 52-89-1 | Various | API QUALITY | Standard | EU DMF | CHE |
| L-Cystine 56-89-3 | Various | PH.EUR. | Standard Fine | CEP EU DMF | CHE |
| Magnesium Orotate 34717-03-8 | Dietary Supplement | API QUALITY | Standard Fine | EU DMF | CHE |
| Mesalamine Mesalazine 5-Aminosalicylic Acid ASA 89-57-6 | Anti-Inflammatory Gastrointestinal | PH.EUR. USP JP | Dense Fine Fine Extra Coarse | CEP EU DMF US DMF# JP DMF CA DMF KR DMF# TW DMF BR DMF CN DMF TH / ID DMF | RAU VIZ |
| Methylene Blue Methylthioninium Chloride 61-73-4 | Vizualization Agent for Colonoscopies Methemoglobinemia | PH.EUR. USP | Standard | EU DMF** US DMF CEP** | VIZ |
| 6-Methyluracil 626-48-2 | Skin Burn Treatment Dietary Supplement | API QUALITY | Standard Micronized | EU DMF RU DMF | CHE |
| N-Acetylcysteine NAC 616-91-1 | Mucolytic Anti-Oxidant Parenteral Nutrition | PH.EUR. USP | Fine N.A.N.H.* Pyrogenfree | CEP EU DMF US DMF# CA DMF BR DMF** IN REG. CERTIFICATE | RAU |
| Nitroglycerin Glyceryl Trinitrate GTN 55-63-0 | Angina Acute Myocardial Infarction Severe Hypertension Acute Coronary Artery Spasms | Pure GTN: INTERNAL SPEC. Mixtures: Ph. Eur., USP | Pure GTN: DNES Mixtures: Multiple grades available | Pure GTN: EU-DMF US-DMF Mixtures: CEP EU-DMF US-DMF JP-DMF | LEV |
| Omega 3 Eicosapentanoic Acid Ethyl Esther Icosapent Ethyl 86227-47-6 | Anti-Inflammatory Cardiovascular | API QUALITY | Standard | US DMF CA DMF EU DMF** | MRX |
| Propafenone Hydrochloride 34183-22-7 | Anti-Arrhythmic | PH.EUR. USP | Fine Coarse Micronized | CEP EU DMF US DMF# CA DMF KR / CN DMF BR DMF TH / ID DMF | RAU CHE |
| S-Carboxymethylcysteine Carbocysteine SCC 638-23-3 | Mucolytic | PH.EUR. JP | Standard Micronized N.A.N.H.* | CEP EU DMF JP DMF ID DMF ROW DMF | CHE |
| S-Carboxymethylcysteine- L-Lysinate 49673-81-6 | Mucolytic | API QUALITY | Standard Dense N.A.N.H.* | EU DMF | CHE |
| Teriflunomide 163451-81-8 | Relapsing Forms Of Multiple Sclerosis | API QUALITY | Standard | US DMF CEP** | VIZ |
| Ursodeoxycholic Acid Ursodiol UDCA 128-13-2 | Cholelitholytic Agent | PH.EUR. IP JP | Standard Milled Milled HF Micronized | CEP EU DMF JP DMF IN REG. CERTIFICATE BR DMF** KR DMF CN DMF** | GRO |
| Zinc Orotate Dihydrate 60388-02-5 | Dietary Supplement | API QUALITY | Standard Micronized | EU DMF | CHE |
Developments
| Active Ingredient CAS Number | Therapeutic Areas | Monograph | Available Grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|
| Betahistine hydrocholride | Antivertigo | API QUALITY | Under Development | DMF | – |
| Bile Acid Derivates | Please contact us if you are looking for such a derivative. | ||||
| Chenodeoxycholic Acid 474-25-9 | Cholelithocholic Agent | API QUALITY | Under Development | DMF | VIZ |
| Cholic Acid 81-25-4 | Building Bloc For Bile Acid Derivates | API QUALITY | Under Development | DMF | VIZ |
| Estetrol 15183-37-6 | Contraceptive | – | – | – | GRO |
| Ethyl-Eicosapents Omega 3 | Dyslipidemia Hypertriglyceridemia | API QUALITY | Under Development | DMF | – |
| Methylprednisolone base 83-43-2 | Advanced Intermediate | PH.EUR. USP | Standard | – | GRO |
| Methylprednisolone hydrogen succinate 2921-57-5 | Anti-Inflammatory | PH.EUR. USP | Standard | – | GRO |
| Mometasone Furoate Monohydrate 141646-00-6 | Respiratory | PH.EUR. USP | Micronized | – | GRO |
| Pinaverium Bromide | Functional gastrointestinal disorders | API QUALITY | Under Development | DMF | – |
| Segesterone Acetate 7759-35-5 | Contraceptive | – | – | – | GRO |