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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.
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 : 62207-971
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 : CA, BR, ASMF |
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.
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.
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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 Olamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltrombopag Olamine, including repackagers and relabelers. The FDA regulates Eltrombopag Olamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltrombopag Olamine 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 Olamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eltrombopag Olamine supplier is an individual or a company that provides Eltrombopag Olamine active pharmaceutical ingredient (API) or Eltrombopag Olamine finished formulations upon request. The Eltrombopag Olamine suppliers may include Eltrombopag Olamine API manufacturers, exporters, distributors and traders.
click here to find a list of Eltrombopag Olamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eltrombopag Olamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltrombopag Olamine active pharmaceutical ingredient (API) in detail. Different forms of Eltrombopag Olamine DMFs exist exist since differing nations have different regulations, such as Eltrombopag Olamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltrombopag Olamine DMF submitted to regulatory agencies in the US is known as a USDMF. Eltrombopag Olamine USDMF includes data on Eltrombopag Olamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltrombopag Olamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltrombopag Olamine suppliers with USDMF on PharmaCompass.
A Eltrombopag Olamine written confirmation (Eltrombopag Olamine WC) is an official document issued by a regulatory agency to a Eltrombopag Olamine manufacturer, verifying that the manufacturing facility of a Eltrombopag Olamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eltrombopag Olamine APIs or Eltrombopag Olamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Eltrombopag Olamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Eltrombopag Olamine 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 Olamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag Olamine 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 Olamine 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 Olamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eltrombopag Olamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eltrombopag Olamine suppliers with NDC on PharmaCompass.
Eltrombopag Olamine 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 Olamine 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 Olamine GMP manufacturer or Eltrombopag Olamine GMP API supplier for your needs.
A Eltrombopag Olamine CoA (Certificate of Analysis) is a formal document that attests to Eltrombopag Olamine's compliance with Eltrombopag Olamine specifications and serves as a tool for batch-level quality control.
Eltrombopag Olamine CoA mostly includes findings from lab analyses of a specific batch. For each Eltrombopag Olamine 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 Olamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Eltrombopag Olamine EP), Eltrombopag Olamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eltrombopag Olamine USP).