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 MonographAvailable
Grades
Regulatory
Documentation
Produced in
16α-HydroxyprednisoloneAdvanced
Intermediate
INTERNAL SPEC.StandardEU DMF
US DMF**
GRO
Amcinonide
51022-69-6
DermatologicUSPMicronizedEU DMFGRO
Beclomethasone
Dipropionate
5534-09-8
RespiratoryPH.EUR.
USP
Standard
Micronized
US DMF#
CEP
SAUDI DMF
CN DMF
GRO
Beclomethasone
Dipropionate
Monohydrate
77011-63-3
RespiratoryPH.EUR.
USP
MicronizedEU DMF
US DMF
GRO
Betamethasone baseAdvanced
Intermediate
PH.EUR.
US DMF
StandardEU DMF
US DMF
GRO
Betamethasone
Dipropionate
5593-20-4
DermatologicPH.EUR.
USP
MicronizedUS DMF#
CEP
SAUDI DMF
GRO
Betamethasone
Valerate
2152-44-5
DermatologicPH.EUR.
USP
MicronizedUS DMF#
JP DMF
CEP
GRO
Brexanolone
516-54-1
CNSINTERNAL SPEC.StandardUS-DMF**GRO
Budesonide
51333-22-3
Respiratory
Gastro-Intestinal
PH.EUR.
USP
JP
MicronizedEU DMF
US DMF#
CEP
JP DMF
SAUDI DMF
GRO
Clascoterone
19608-29-8
DermatologicINTERNAL SPEC.StandardDMF**GRO
Chlormadinone
Acetate
302-22-7
ContraceptivePH.EUR.
JP
MicronizedJP DMF
CEP
GRO
Clobetasol
Propionate
25122-46-7
DermatologicPH.EUR.
USP
MicronizedUS DMF#
JP DMF
CEP
SAUDI DMF
GRO
Clobetasone
Butyrate
25122-57-0
DermatologicPH.EUR.MicronizedEU DMFGRO
Clocortolone
Pivalate
34097-16-0
DermatologicUSPMicronizedEU DMF
US DMF
GRO
Cyproterone
Acetate
427-51-0
Anti-AndrogenPH.EUR.MicronizedUS DMF
CEP
GRO
Delmadinone Acetate
13698-449-2
Anti-Androgen (Veterinary)INTERNAL SPEC.MicronizedEU DMFGRO
Desonide
638-94-8
DermatologicUSPMicronizedEU DMF
US DMF#
CN DMF
GRO
Desonide
Sodium
Phosphate
94087-98-6
OphthalmicINTERNAL
SPEC.
StandardEU DMFGRO
Desoximetasone
382-67-2
Dermatologic
Ophthalmic
USPMicronizedEU DMF
US DMF#
GRO
Dexametasone
50-02-2
Anti-InflammatoryUSPMicronizedEU DMF
US DMF#
GRO
Dexametasone Sodium Phosphate
312-93-6
Anti-InflammatoryPH.Eur.
USP
StandardEU DMFGRO
Diflorasone
Diacetate
2557-49-5

Dermatologic
JP
USP
StandardEU DMFGRO
Diflucortolone
Valerate
59198-70-8
DermatologicBP
JP
MicronizedEU DMF
JP DMF
GRO
Difluprednate
23674-86-4
OphthalmicINTERNAL
SPEC.
MicronizedEU DMF
US DMF#
JP DMF
GRO
Exemestane
107868-30-4
Anti-CancerPH.EUR.
USP
MicronizedUS DMF#
CEP
GRO
Fludrocortisone
Acetate
514-36-3
Adrenocortical
Insufficiency
PH.EUR.
USP
MicronizedUS DMF
CEP
GRO
Fludrocortisone
Base
127-31-1
Anti-InflammatoryINTERNAL
SPEC.
MicronizedEU DMFGRO
Flumethasone
  2135-17-3
Advanced IntermediateINTERNAL
SPEC.
MicronizedEU DMF
US DMF
GRO
Flumethasone
Pivalate
2002-29-1
DermatologicPH.EUR.
USP
MicronizedEU DMFGRO
Flunisolide
Anhydrous
3385-03-3
Anti-AsthmaticUSPMicronizedEU DMF
US DMF#
GRO
Flunisolide
Hemihydrate
77326-96-6
RespiratoryUSPMicronizedEU DMF
US DMF#
GRO
Fluocinonide
356-12-7
DermatologicUSP
BP
MicronizedEU DMF
US DMF#
JP DMF
GRO
Fluocinolone
Acetonide
67-73-2
DermatologicPH.EUR.
USP
MicronizedUS DMF#
JP DMF
CEP
CN DMF
SAUDI DMF
GRO
Fluocortolone hexanoate (Caproate)
303-40-2
DermatologicPH.EUR.MicronizedEU DMFGRO
Fluocortolone pivalate
29205-06-9
DermatologicPH.EUR.MicronizedEU DMFGRO
Fluorometholone
Base
426-13-1
OphthalmicUSP
JP
MicronizedEU DMF
JP DMF
US DMF
GRO
Fluprednidene Acetate
1255-35-2
DermatologicINTERNAL SPEC.StandardEU DMFGRO
Flurandrenolide
1524-88-5
DermatologicUSPMicronizedEU DMF
US DMF#
JP DMF
GRO
Fluticasone
Furoate
397864-44-7
RespiratoryINTERNAL
SPEC.
MicronizedEU DMFGRO
Fluticasone
Propionate
80474-14-2
RespiratoryPH.EUR.
USP
MicronizedUS DMF#
CEP
GRO
Fulvestrant
129453-61-8
Anti-CancerPH.EUR.
USP
StandardUS DMF#
CEP
GRO
Halcinonide
3093-35-4
DermatologicUSPMicronizedEU DMF
US DMF#
CN DMF
GRO
Halometasone
Monohydrate
50629-82-8
DermatologicINTERNAL
SPEC.
MicronizedEU DMFGRO
Hydrocortisone
Acetate
50-03-3
Dermatologic
Ophthalmic
PH.EUR.
USP
MicronizedCEP**GRO
Hydrocortisone hydrogen succinate
2203-97-6
Anti-InflammatoryPH.EUR.
USP
StandardEU DMF
US DMF
GRO
Loteprednol
Etabonate
82034-46-6
OphthalmicINTERNAL
SPEC.
StandardEU DMF
US DMF#
GRO
Medroxyprogesterone
Acetate
71-58-9
ContraceptivePH.EUR.
USP
MicronizedUS DMF
CEP
JP DMF
GRO
Megestrol
Acetate
595-33-5
Anti-CancerPH.EUR.
USP
MicronizedUS DMF#
CEP
GRO
Methylprednisolone Aceponate
86401-95-8
Topical/DermatologicINTERNAL SPEC.Standard
Micronized
EU DMFGRO
Methyltestosterone
58-18-4
Anabolic-
Androgenic
PH.EUR.
USP
MicronizedEU DMF
US DMF#
GRO
Mometasone
Furoate
83919-23-7
Respiratory-
Dermatologic
PH.EUR.
USP
MicronizedUS DMF#
CEP
SAUDI DMF
GRO
Osaterone
Acetate
105149-04-0
Anti-Androgen
(Veterinary)
JPMicronizedEU DMFGRO
Paramethasone
Acetate
1597-82-6
DermatologicINTERNAL
SPEC.
MicronizedEU DMFGRO
Prednisolone
Acetate
52-21-1
DermatologicPH.EUR.
USP
StandardCEPGRO
Prednisolone
Hexanoate (Caproate)
69164-69-8
DermatologicINTERNAL
SPEC.
StandardEU DMFGRO
Prednisolone
Valerate
Acetate
72064-79-0
 
Dermatologic
INTERNAL
SPEC.
MicronizedEU DMF
JP DMF
GRO
Prednisolone
Sodium Metasulfobenzoate
3694-41-5
Anti-InflammatoryINTERNAL
SPEC.
StandardEU DMFGRO
Triamcinolone
124-94-7
Dermatologic
Ophthalmic
PH.EUR.
USP
MicronizedEU DMFGRO
Triamcinolone
Acetonide
76-25-5
Dermatologic
Ophthalmic
PH.EUR.
USP
MicronizedUS DMF#
CEP
GRO
Triamcinolone
Diacetate
67-78-7
Dermatologic
Ophthalmic
USPMicronizedEU DMF
US DMF
GRO
Triamcinolone
Hexacetonide
5611-51-8
Anti-InflammatoryPH.EUR.
USP
Standard
Micronized
US DMF
CEP
GRO

Sterile Steroids

Active Ingredient
CAS Number
Therapeutic Areas MonographAvailable
Grades
Regulatory
Documentation
Produced in
Beclomethasone
Dipropionate
5534-09-8
RespiratoryPH.EUR.
USP
MicronizedEU DMFGRO
Budesonide
51333-22-3
RespiratoryPH.EUR.
USP
MicronizedEU DMF
US DMF
GRO
Hydrocortisone
Acetate
50-03-3
OphthalmicPH.EUR.
USP
MicronizedEU DMFGRO
Loteprednol
Etabonate
82034-46-6
OphthalmicINTERNAL
SPEC.
MicronizedEU DMF
US DMF
GRO
Medroxyprogesterone
Acetate (WHO Pre-Qualified)
71-58-9
ContraceptivePH.EUR.
USP
MicronizedUS DMF#
WHO DMF
GRO
Methylprednisolone
Acetate
53-36-1
Injectable
Anti-Inflammatory
PH.EUR.
USP
MicronizedEU DMF
US DMF#
CEP*
GRO
Prednisolone
Acetate
52-21-1
Ophthalmic
Injectable
Anti-Inflammatory
PH.EUR.
USP
MicronizedUS DMF#
CEP
GRO
Prednisolone
Base
50-24-8
Anti-Inflammatory
(Veterinary)
PH.EUR.
USP
MicronizedEU DMFGRO
Triamcinolone
Acetonide
76-25-5
Injectable
Anti-Inflammatory
PH.EUR.
USP
MicronizedEU DMF
US DMF#
JP DMF
CEP*
GRO

High Potent Substances

Active Ingredient
CAS Number
Therapeutic Areas MonographAvailable
Grades
Regulatory
Documentation
Produced in
Cannabidiol
(CBD, Synthetic)
13956-29-1
VariousDAC (German Drug Codex)StandardEU DMF
US DMF
GRO
Formoterol
Fumarate
Dihydrate
183814-30-4
RespiratoryPH.EUR.
USP
MicronizedUS DMF
CEP
GRO
Tirofiban
Hydrochloride
Monohydrate
150915-40-5
CardiovascularINTERNAL
SPEC.
StandardEU DMF
US DMF
GRO
Salmeterol
Xinafoate
94749-08-3
RespiratoryINTERNAL
SPEC.
MicronizedCEPGRO

Cytotoxics

Active Ingredient
CAS Number
Therapeutic Areas MonographAvailable
Grades
Regulatory
Documentation
Produced in
Busulfan
55-98-1
Anti-CancerPH.EUR.
USP
JP
StandardUS DMF#
CEP
SAUDI DMF
GRO
Melphalan HCl
3223-07-2
Anti-CancerINTERNAL
SPEC.
StandardEU DMF
US DMF#
SAUDI DMF
CN DMF
GRO

Specialty Products

Active Ingredient
CAS Number
Therapeutic Areas MonographAvailable
Grades
Regulatory
Documentation
Produced in
Balsalazide Disodium
150399-21-6
Anti-Inflammatory
Gastrointestinal
USPStandard
Fine
Dense
US DMF#
EU DMF
RAU
CHE
Celecoxib (Form III)
169590-42-5
NSAIDPH.EUR.
USP
Fine
Micronized
CEP
EU DMF
US DMF#
CA DMF
VIZ
Esmolol hydrochloride
81161-17-3
Anti-ArrhythmicAPI QUALITYStandardUS DMF
CA DMF
EU DMF
CSR
Etoricoxib (Form I)
202409-33-4
ArthritisAPI QUALITYStandard
Micronized
EU DMFVIZ
Indapamide
26807-65-8
Anti-Hypertensive
Diuretic
PH.EUR.Standard
Micronized
CEP
EU DMF
VIZ
L-Cysteine HCL Monohydrate
7048-04-6
VariousPH.EUR.StandardCEP
EU DMF
CHE
L-Cysteine HCl
Anhydrous
52-89-1
VariousAPI QUALITYStandardEU DMFCHE
L-Cystine
56-89-3
VariousPH.EUR.Standard
Fine
CEP
EU DMF
CHE
Magnesium  Orotate
34717-03-8
Dietary SupplementAPI QUALITYStandard
Fine
EU DMFCHE
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
StandardEU DMF**
US DMF
CEP**
VIZ
6-Methyluracil
626-48-2
Skin Burn Treatment
Dietary Supplement
API QUALITYStandard
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 QUALITYStandardUS DMF
CA DMF
EU DMF**
MRX
Propafenone
Hydrochloride
34183-22-7
Anti-ArrhythmicPH.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
MucolyticPH.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
MucolyticAPI QUALITYStandard
Dense
N.A.N.H.*
EU DMFCHE
Teriflunomide
163451-81-8
Relapsing Forms Of Multiple SclerosisAPI QUALITYStandardUS DMF
CEP**
VIZ
Ursodeoxycholic Acid
Ursodiol
UDCA
128-13-2
Cholelitholytic AgentPH.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 SupplementAPI QUALITYStandard
Micronized
EU DMFCHE

Developments

Active Ingredient
CAS Number
Therapeutic AreasMonographAvailable
Grades
Regulatory
Documentation
Produced in
Betahistine hydrocholrideAntivertigoAPI QUALITYUnder DevelopmentDMF
Bile Acid DerivatesPlease contact us if you are looking for such a derivative.   
Chenodeoxycholic Acid
474-25-9
Cholelithocholic AgentAPI QUALITYUnder DevelopmentDMFVIZ
Cholic Acid
81-25-4
Building Bloc For Bile Acid DerivatesAPI QUALITYUnder DevelopmentDMFVIZ
Estetrol
15183-37-6
ContraceptiveGRO
Ethyl-Eicosapents
Omega 3
Dyslipidemia 
Hypertriglyceridemia
API QUALITYUnder DevelopmentDMF
Methylprednisolone base
83-43-2
Advanced
Intermediate
PH.EUR.
USP
StandardGRO
Methylprednisolone hydrogen succinate
2921-57-5
Anti-InflammatoryPH.EUR.
USP
StandardGRO
Mometasone
Furoate Monohydrate
141646-00-6
RespiratoryPH.EUR.
USP
MicronizedGRO
Pinaverium BromideFunctional gastrointestinal disordersAPI QUALITYUnder DevelopmentDMF
Segesterone Acetate      
7759-35-5
ContraceptiveGRO

Interested in speaking with Axplora experts about your generic drug development needs? Simply click here