Synopsis
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USDMF
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS
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Weekly News Recap #Phispers
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API Imports and Exports
Drugs in Development
Lead Product(s) : Methotrexate,Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Methotrexate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Arthritis, Rheumatoid.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
January 10, 2013
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Uveitis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
June 10, 2022
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eisai
Deal Size : Inapplicable
Deal Type : Inapplicable
Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regi...
Details : HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.
Product Name : Humira
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 27, 2021
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eisai
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.
Product Name : Humira
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 24, 2021
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eisai
Deal Size : Inapplicable
Deal Type : Inapplicable
HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to ...
Details : Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission a...
Product Name : Humira
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
February 24, 2021
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pyoderma Gangrenosum.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
October 17, 2017
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : waqqas.afif
Deal Size : Inapplicable
Deal Type : Inapplicable
TDM Guided Early Optimization of ADAL in Crohn's Disease
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in clinical studies for the treatment of Crohn Disease.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
August 24, 2017
Lead Product(s) : Adalimumab,Methotrexate
Therapeutic Area : Dermatology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Jeffrey J Crowley MD
Deal Size : Inapplicable
Deal Type : Inapplicable
MAP Study: Methotrexate and Adalimumab in Psoriasis
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Psoriasis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
July 14, 2017
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hidradenitis Suppurativa.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 19, 2016
Lead Product(s) : Adalimumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : IST GmbH | Hannover Medical School | Improvement by Movement
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Adalimumab is a Antibody drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Axial Spondyloarthritis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 13, 2016
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
Parenteral
Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Solubilizers
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Co-Processed Excipients
Granulation
Topical
Surfactant & Foaming Agents
Emulsifying Agents
Film Formers & Plasticizers
Rheology Modifiers
API Stability Enhancers
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Health Canada Patents
Patent Expiration Date : 2017-02-10
Date Granted : 2002-09-17
Brand Name : HUMIRA
Patent Number : 2243459
Filing Date : 1997-02-10
Strength per Unit : 50 mg / mL (40 mg in 0.8 mL)
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2017-02-10
Date Granted : 2002-09-17
Patent Expiration Date : 2022-05-10
Date Granted : 2015-02-17
Brand Name : HUMIRA
Patent Number : 2385745
Filing Date : 2002-05-10
Strength per Unit : 50 mg / mL (40 mg in 0.8 mL)
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2022-05-10
Date Granted : 2015-02-17
Patent Expiration Date : 2023-08-15
Date Granted : 2014-07-22
Brand Name : HUMIRA
Patent Number : 2494756
Filing Date : 2003-08-15
Strength per Unit : 50 mg / mL (40 mg in 0.8 mL)
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2023-08-15
Date Granted : 2014-07-22
Patent Expiration Date : 2025-04-11
Date Granted : 2015-04-07
Brand Name : HUMIRA
Patent Number : 2847142
Filing Date : 2005-04-11
Strength per Unit : 50 mg / mL (40 mg in 0.8 mL)
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2025-04-11
Date Granted : 2015-04-07
Patent Expiration Date : 2025-04-11
Date Granted : 2016-11-29
Brand Name : HUMIRA
Patent Number : 2504868
Filing Date : 2005-04-11
Strength per Unit : 50 mg / mL (40 mg in 0.8 mL)
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2025-04-11
Date Granted : 2016-11-29
Patent Expiration Date : 2025-04-11
Date Granted : 2015-04-07
Brand Name : HUMIRA
Patent Number : 2847142
Filing Date : 2005-04-11
Strength per Unit : 100mg / mL (40mg / 0.4mL)
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2025-04-11
Date Granted : 2015-04-07
Patent Expiration Date : 2017-02-10
Date Granted : 2002-09-17
Brand Name : HUMIRA
Patent Number : 2243459
Filing Date : 1997-02-10
Strength per Unit : 100mg / mL (40mg / 0.4mL)
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2017-02-10
Date Granted : 2002-09-17
Patent Expiration Date : 2022-05-10
Date Granted : 2015-02-17
Brand Name : HUMIRA
Patent Number : 2385745
Filing Date : 2002-05-10
Strength per Unit : 100mg / mL (40mg / 0.4mL)
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2022-05-10
Date Granted : 2015-02-17
Patent Expiration Date : 2031-11-11
Date Granted : 2016-11-22
Brand Name : HUMIRA
Patent Number : 2815689
Filing Date : 2011-11-11
Strength per Unit : 100mg / mL (40mg / 0.4mL)
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2031-11-11
Date Granted : 2016-11-22
Patent Expiration Date : 2025-04-11
Date Granted : 2016-11-29
Brand Name : HUMIRA
Patent Number : 2504868
Filing Date : 2005-04-11
Strength per Unit : 100mg / mL (40mg / 0.4mL)
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2025-04-11
Date Granted : 2016-11-29
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