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1. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-
2. Ddl-701
3. Eltrombopag
4. Promacta
5. Revolade
6. Sb-497 115
7. Sb-497-115
8. Sb497115
1. 496775-62-3
2. Revolade
3. Promacta
4. Eltrombopag (olamine)
5. Unii-4u07f515lg
6. Sb-497115-gr
7. Eltrombopag Diethanolamine Salt
8. 496775-62-3 (olamine)
9. Eltrombopag (as Olamine)
10. 4u07f515lg
11. Sb-497115gr
12. Eltrombopag Compd With 2-aminoethanol (1:2)
13. Eltrombopag Diethanolamine Salt;sb-497115gr
14. (z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxyiic Acid;2-aminoethan-1-ol (1:2)
15. 3'-((2z)-2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic Acid Compound With 2-aminoethanol (1:2)
16. Promacta Olamine
17. Eltrombopagolamine
18. Eltrombopag Olamine [usan:jan]
19. Promacta (tn)
20. Sb 497115gr
21. Schembl210183
22. Amy267
23. Chembl3989691
24. Schembl16207741
25. Schembl23458316
26. Eltrombopag Olamine (jan/usan)
27. Eltrombopag Olamine [jan]
28. Eltrombopag Olamine [usan]
29. Bcp07055
30. Eltrombopag Olamine [mart.]
31. Eltrombopag Olamine [who-dd]
32. Hy-15306a
33. Mfcd22380664
34. S2229
35. Akos025396658
36. Akos037515856
37. Ccg-270074
38. Cs-1566
39. Sb19102
40. Eltrombopag Olamine [orange Book]
41. 2-aminoethan-1-ol Hemi((e)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1h-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)
42. Ac-26286
43. Bs-17370
44. Ft-0773802
45. D03978
46. A904098
47. Q27260489
48. Eltrombopag Compd With 2-aminoethanol (1:2) [mi]
49. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, Compound With 2-aminoethanol (1:2)
50. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-, Compound With 2-aminoethanol (1:2)
51. (1,1'-biphenyl)-3-carboxylic Acid, 3'-(2-(1-(3,4-dimethylphenyl)-4,5-dihydro-3-methyl-5-oxo-1h-pyrazol-4-yl)diazenyl)-2'-hydroxy-, Compd. With 2-aminoethanol (1:2)
52. 2-aminoethan-1-ol Hemi((z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate)
53. 2-aminoethanol (e)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-pyrazol-4(5h)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate
54. 2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1h-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic Acid
55. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)
56. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)
57. 3'-{(2z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic Acid 2-aminoethanol (1:2)
Molecular Weight | 564.6 g/mol |
---|---|
Molecular Formula | C29H36N6O6 |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 7 |
Exact Mass | 564.26963289 g/mol |
Monoisotopic Mass | 564.26963289 g/mol |
Topological Polar Surface Area | 207 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 822 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).
Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).
Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. 1).
Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5. 1).
B02BX05
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40868
Submission : 2024-11-28
Status : Active
Type : II
NDC Package Code : 52076-6274
Start Marketing Date : 2022-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC Package Code : 62207-971
Start Marketing Date : 2021-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR, CA |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-25
Pay. Date : 2022-09-28
DMF Number : 37269
Submission : 2022-08-29
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38008
Submission : 2023-03-31
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-067
Start Marketing Date : 2024-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-111
Start Marketing Date : 2024-10-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-13
Pay. Date : 2024-01-08
DMF Number : 39129
Submission : 2023-12-31
Status : Active
Type : II
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm :
NDC Package Code : 62207-988
Start Marketing Date : 2024-03-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR, CA |
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Undisclosed
Lead Product(s): Ripertamab,Eltrombopag
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibody
Sponsor: Sinocelltech Ltd.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 24, 2025
Lead Product(s) : Ripertamab,Eltrombopag
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Sinocelltech Ltd.
Deal Size : Inapplicable
Deal Type : Inapplicable
Ripertamab Plus Eltrombopag vs. Eltrombopag in ITP Patients Post-Steroid Failure
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
January 24, 2025
Details:
Undisclosed
Lead Product(s): Ruxolitinib Phosphate,Eltrombopag
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 23, 2024
Lead Product(s) : Ruxolitinib Phosphate,Eltrombopag
Therapeutic Area : Immunology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2024
Details:
Undisclosed
Lead Product(s): Eltrombopag,Prednisolone
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 31, 2024
Lead Product(s) : Eltrombopag,Prednisolone
Therapeutic Area : Immunology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2024
Details:
Undisclosed
Lead Product(s): Hydroxychloroquine Sulphate,Eltrombopag
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Other Small Molecule
Sponsor: Shanghai Zhongshan Hospital | Shanghai Jinshan Hospital | Zhongshan Qingpu Hospital, Fudan University | Zhongshan Wusong Hospital, Fudan University | Macau University of Science and Technology Hospital | Health and Humanity Research Centre, Hongkong | Dr.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 28, 2024
Lead Product(s) : Hydroxychloroquine Sulphate,Eltrombopag
Therapeutic Area : Hematology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Shanghai Zhongshan Hospital | Shanghai Jinshan Hospital | Zhongshan Qingpu Hospital, Fudan University | Zhongshan Wusong Hospital, Fudan University | Macau University of Science and Technology Hospital | Health and Humanity Research Centre, Hongkong | Dr.
Deal Size : Inapplicable
Deal Type : Inapplicable
The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 28, 2024
Details:
Undisclosed
Lead Product(s):
Ruxolitinib Phosphate,Allogeneic Stem Cell Transplant,Levetiracetam,Eltrombopag,Busulfan,Semaxanib,Fludarabine Phosphate,Cyclophosphamide,Mesna,
Therapeutic Area: Hematology
Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule Sponsor:
Incyte Corporation
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
April 03, 2024
Lead Product(s) :
Ruxolitinib Phosphate,Allogeneic Stem Cell Transplant,Levetiracetam,Eltrombopag,Busulfan,Semaxanib,Fludarabine Phosphate,Cyclophosphamide,Mesna,
Therapeutic Area :
Hematology Highest Development Status :
Phase II Partner/Sponsor/Collaborator :
Incyte Corporation Deal Size : Inapplicable Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 03, 2024
Details:
Undisclosed
Lead Product(s): Eltrombopag,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2023
Lead Product(s) : Eltrombopag,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Eltrombopag for Peripheral Blood Stem Cell Harvest
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 27, 2023
Details:
Undisclosed
Lead Product(s): Adagrasib,Eltrombopag
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2023
Lead Product(s) : Adagrasib,Eltrombopag
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 29, 2023
Details:
Undisclosed
Lead Product(s): Ianalumab,Eltrombopag
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 16, 2022
Lead Product(s) : Ianalumab,Eltrombopag
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
December 16, 2022
Details:
Undisclosed
Lead Product(s): Eltrombopag,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2022
Lead Product(s) : Eltrombopag,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Eltrombopag Treatment in Patients With Prolonged BM Toxicity After CART
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 18, 2022
Details:
Undisclosed
Lead Product(s): Eltrombopag,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2021
Lead Product(s) : Eltrombopag,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 08, 2021
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2038-11-05
US Patent Number : 11072586
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216774
Patent Use Code : U-3937
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-11-05
Patent Expiration Date : 2038-11-05
US Patent Number : 11072586
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216774
Patent Use Code : U-3937
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-11-05
Patent Expiration Date : 2025-07-13
US Patent Number : 7547719
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22291
Patent Use Code : U-1575
Delist Requested :
Patent Use Description : PATIENTS WITH SEVERE A...
Patent Expiration Date : 2025-07-13
Patent Expiration Date : 2028-02-01
US Patent Number : 8828430*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 22291
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-02-01
Patent Expiration Date : 2027-08-01
US Patent Number : 8052993
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22291
Patent Use Code : U-1714
Delist Requested :
Patent Use Description : TREATMENT OF THROMBOCY...
Patent Expiration Date : 2027-08-01
Patent Expiration Date : 2028-02-01
US Patent Number : 8052993*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 22291
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-02-01
Patent Expiration Date : 2027-08-01
US Patent Number : 8052993
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22291
Patent Use Code : U-1714
Delist Requested :
Patent Use Description : TREATMENT OF THROMBOCY...
Patent Expiration Date : 2027-08-01
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
69
PharmaCompass offers a list of Eltrombopag API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Eltrombopag manufacturer or Eltrombopag supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eltrombopag manufacturer or Eltrombopag supplier.
PharmaCompass also assists you with knowing the Eltrombopag API Price utilized in the formulation of products. Eltrombopag API Price is not always fixed or binding as the Eltrombopag Price is obtained through a variety of data sources. The Eltrombopag Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eltrombopag manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltrombopag, including repackagers and relabelers. The FDA regulates Eltrombopag manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltrombopag API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Eltrombopag manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eltrombopag supplier is an individual or a company that provides Eltrombopag active pharmaceutical ingredient (API) or Eltrombopag finished formulations upon request. The Eltrombopag suppliers may include Eltrombopag API manufacturers, exporters, distributors and traders.
click here to find a list of Eltrombopag suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eltrombopag DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltrombopag active pharmaceutical ingredient (API) in detail. Different forms of Eltrombopag DMFs exist exist since differing nations have different regulations, such as Eltrombopag USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltrombopag DMF submitted to regulatory agencies in the US is known as a USDMF. Eltrombopag USDMF includes data on Eltrombopag's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltrombopag USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltrombopag suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Eltrombopag Drug Master File in Japan (Eltrombopag JDMF) empowers Eltrombopag API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Eltrombopag JDMF during the approval evaluation for pharmaceutical products. At the time of Eltrombopag JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Eltrombopag suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eltrombopag Drug Master File in Korea (Eltrombopag KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eltrombopag. The MFDS reviews the Eltrombopag KDMF as part of the drug registration process and uses the information provided in the Eltrombopag KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eltrombopag KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eltrombopag API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eltrombopag suppliers with KDMF on PharmaCompass.
A Eltrombopag written confirmation (Eltrombopag WC) is an official document issued by a regulatory agency to a Eltrombopag manufacturer, verifying that the manufacturing facility of a Eltrombopag active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eltrombopag APIs or Eltrombopag finished pharmaceutical products to another nation, regulatory agencies frequently require a Eltrombopag WC (written confirmation) as part of the regulatory process.
click here to find a list of Eltrombopag suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Eltrombopag as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Eltrombopag as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Eltrombopag and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eltrombopag NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eltrombopag suppliers with NDC on PharmaCompass.
Eltrombopag Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Eltrombopag GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Eltrombopag GMP manufacturer or Eltrombopag GMP API supplier for your needs.
A Eltrombopag CoA (Certificate of Analysis) is a formal document that attests to Eltrombopag's compliance with Eltrombopag specifications and serves as a tool for batch-level quality control.
Eltrombopag CoA mostly includes findings from lab analyses of a specific batch. For each Eltrombopag CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Eltrombopag may be tested according to a variety of international standards, such as European Pharmacopoeia (Eltrombopag EP), Eltrombopag JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eltrombopag USP).