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Also known as: 496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr
Molecular Formula
C29H36N6O6
Molecular Weight
564.6  g/mol
InChI Key
DJMJHIKGMVJYCW-UHFFFAOYSA-N
FDA UNII
4U07F515LG

Eltrombopag
Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.
1 2D Structure

Eltrombopag

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic acid
2.1.2 InChI
InChI=1S/C25H22N4O4.2C2H7NO/c1-14-10-11-19(12-15(14)2)29-24(31)22(16(3)28-29)27-26-21-9-5-8-20(23(21)30)17-6-4-7-18(13-17)25(32)33;2*3-1-2-4/h4-13,28,30H,1-3H3,(H,32,33);2*4H,1-3H2
2.1.3 InChI Key
DJMJHIKGMVJYCW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=C(C=C1)N2C(=O)C(=C(N2)C)N=NC3=CC=CC(=C3O)C4=CC(=CC=C4)C(=O)O)C.C(CO)N.C(CO)N
2.2 Other Identifiers
2.2.1 UNII
4U07F515LG
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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)

2.4 Create Date
2019-01-15
3 Chemical and Physical Properties
Molecular Weight 564.6 g/mol
Molecular Formula C29H36N6O6
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count11
Rotatable Bond Count7
Exact Mass564.26963289 g/mol
Monoisotopic Mass564.26963289 g/mol
Topological Polar Surface Area207 Ų
Heavy Atom Count41
Formal Charge0
Complexity822
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

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).


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Increased Megakaryocyte Maturation [PE]; Increased Platelet Production [PE]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Thrombopoietin Receptor Agonist [EPC]; Thrombopoietin Receptor Agonists [MoA]; UGT1A1 Inhibitors [MoA]; UGT1A3 Inhibitors [MoA]; UGT1A4 Inhibitors [MoA]; UGT1A6 Inhibitors [MoA]; UGT1A9 Inhibitors [MoA]; UGT2B15 Inhibitors [MoA]; UGT2B7 Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
5.2 ATC Code

B02BX05


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ELTROMBOPAG OLAMINE

NDC Package Code : 52076-6274

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About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...

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About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

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About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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About the Company : Kimia Biosciences, established in 1993, is focused on manufacturing bulk drugs for various therapeutic segments. With a strong emphasis on excellence and advanced technologies, Kim...

Kimia Biosciences, established in 1993, is focused on manufacturing bulk drugs for various therapeutic segments. With a strong emphasis on excellence and advanced technologies, Kimia aims to become a globally recognized company in both APIs and FDFs while upholding clean business practices. Kimia's state-of-the-art facilities at Village Bhondsi, Gurugram enable it to produce a wide range of APIs. Kimia also plans to establish its own facilities for lifestyle segments, adhering to international regulatory standards. Kimia aims to provide the best pharmaceutical products and support to consumers and healthcare professionals.
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05-Jan-2021
29-Apr-2025
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DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 12.5MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 25MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 50MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 75MG ACID

USFDA APPLICATION NUMBER - 22291

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ABOUT THIS PAGE

Looking for 496775-62-3 / Eltrombopag API manufacturers, exporters & distributors?

Eltrombopag manufacturers, exporters & distributors 1

33

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.

API | Excipient name

Eltrombopag

Synonyms

496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr

Cas Number

496775-62-3

Unique Ingredient Identifier (UNII)

4U07F515LG

About Eltrombopag

Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.

Eltrombopag Manufacturers

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.

Eltrombopag Suppliers

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.

Eltrombopag USDMF

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.

Eltrombopag JDMF

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.

Eltrombopag KDMF

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.

Eltrombopag WC

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.

Eltrombopag NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Eltrombopag CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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