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APIs with Axplora

At Axplora, we take pride in providing an extensive and diverse portfolio of small-molecule active pharmaceutical ingredients (APIs) that cater to the evolving needs of the pharmaceutical industry. As a prominent figure in the global pharmaceutical landscape, we have established ourselves as a leading manufacturer, specializing in non-sterile and sterile steroids.

Trusted by global pharma

Axplora has built lasting partnerships with leading pharmaceutical companies. Our API portfolio reflects both depth and diversity — supporting generic programs, innovator molecules and HPAPIs.

With decades of process R&D expertise, we manufacture sustainable, technologically advanced, high-performance APIs that enable world-class therapies to reach worldwide patients.

Specialty Products

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
MesalamineMesalazine 5- Aminosalicylic AcidASA 89-57-6-SP Anti-Inflammatory Gastrointestinal EP, JP, USP Dense Fine Fine Extra Coarse BR DMF
CA DMF
CEP
EU DMF
JP DMF
KR DMF#
TH / ID DMF
TW DMF
US DMF#
RAU, VIZ
Ursodeoxycholic Acid Ursodiol UDCA 128-13-2-SP Gallstone Dissolution, Primary Biliary Cholangitis EP, IP, JP, USP Micronized
Milled
Standard
BR DMF**
CEP (DUAL)
EU DMF
IN REG. CERTIFICATE
JP DMF**
KR DMF**
US DMF#
GRO, VIZ
N-Acetylcysteine NAC 616-91-1-SP Anti-Oxidant, Mucolytic, Parenteral Nutrition EP, USP Fine
N.A.N.H.*
Pyrogenfree
BR DMF**
CA DMF
CEP
CN DMF**
EU DMF
IN REG. CERTIFICATE
US DMF#
CHE, RAU
S-Carboxymethylcysteine Carbocysteine SCC 638-23-3-SP Mucolytic EP, JP Micronized
N.A.N.H.*
Standard
CEP
EU DMF
ID DMF
JP DMF
ROW DMF
CHE
Propafenone Hydrochloride 34183-22-7-SP Anti-Arrhythmic EP, USP Coarse
Fine
Micronized
BR DMF
CA DMF
CEP
EU DMF
KR / CN DMF
TH / ID DMF
US DMF#
CHE, RAU

Specialty Product Developments

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
Bile Salts NO.3 Culture Media & Diagnostics CEP (BSE/TSE)** VIZ
Glycocholic acid 475-31-0-SPD EXCIPIENT EXCIPIENT Standard CEP (BSE/TSE) VIZ
Lysine Monohydrate 39665-12-8-SPD α-Amino Acid Used in a Wide Range of Applications API QUALITY, EXCIPIENT Standard EU DMF**
US DMF**
CHE
Metheneamine Hippurate 5714-73-8-SPD Urinary Tract Infection Standard CHE, VIZ
Sodium Deoxycholate 302-95-4-SPD Culture Media & Diagnostics EXCIPIENT Standard CEP (BSE/TSE)** VIZ

Cytotoxics

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
Busulfan 55-98-1-C Anti-Cancer JP, PH.EUR., USP Standard CEP
SAUDI DMF
US DMF**
GRO
Melphalan HCl 3223-07-02-C Cytotoxics INTERNAL, SPEC. Standard CN DMF
EU DMF
SAUDI DMF
US DMF**
GRO

High Potent Substances

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
Cannabidiol (CBD, Synthetic) 13956-29-1-HPS Various DAC (German Drug Codex) Standard EU DMF
US DMF**
GRO
Formoterol Fumarate Dihydrate 183814-30-4-HPS Respiratory PH.EUR., USP Micronized CEP
US DMF**
GRO
Salmeterol Xinafoate 94749-08-03-HPS Respiratory INTERNAL, SPEC. Micronized CEP GRO
Tirofiban Hydrochloride Monohydrate 150915-40-5-HPS Cardiovascular INTERNAL, SPEC. Standard EU DMF
US DMF**
GRO

Sterile Steroids

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
Beclomethasone Dipropionate 5534-09-08-SS Respiratory PH.EUR., USP Micronized EU DMF GRO
Budesonide 51333-22-3-SS Respiratory PH.EUR., USP Micronized EU DMF
US DMF**
GRO
Hydrocortisone Acetate 50-03-3-SS Ophthalmic PH.EUR., USP Micronized CEP
EU DMF
GRO
Loteprednol Etabonate 82034-46-6-SS Ophthalmic INTERNAL, SPEC. Micronized EU DMF
US DMF**
GRO
Medroxyprogesterone Acetate (WHO Pre-Qualified) 71-58-9-SS Contraceptive PH.EUR., USP Micronized US DMF**
WHO DMF
GRO

Steroid Developments

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
Estetrol 15183-37-6-SD Contraceptive GRO
Miristyl-Gamma-Picolinium 0000-00-0-SD Please contact us if you are looking for such a derivative.
Mometasone Furoate Monohydrate 141646-00-6-SD Respiratory PH.EUR., USP Micronized EU DMF GRO
Segesterone Acetate 7759-35-5-SD Contraceptive INTERNAL SPEC. Standard EU DMF GRO
Umeclidinium bromide 0000-000-SD Please contact us if you are looking for such a derivative.

Steroids

Active Ingredient CAS Number Therapeutic areas Monograph Available grades Regulatory Documentation Produced in
16α-Hydroxyprednisolone 13951-70-7-S Advanced, Intermediate INTERNAL SPEC. Standard EU DMF
US DMF**
GRO
Amcinonide 51022-69-6-S Dermatologic USP Micronized EU DMF GRO
Beclomethasone Dipropionate 5534-09-08-S Respiratory PH.EUR., USP Micronized
Standard
CEP
CN DMF
SAUDI DMF
US DMF**
GRO
Beclomethasone Dipropionate Monohydrate 77011-63-3-S Respiratory PH.EUR., USP Micronized EU DMF
US DMF**
GRO
Betamethasone base 0000-00-S Advanced, Intermediate PH.EUR., USP Standard EU DMF
US DMF**
GRO

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