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    Chemistry

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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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    Zhejiang Hengkang Pharmaceutical

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    About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

    Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...

    Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain- APIs, Formulation Intermediates, & Formulations. With 11 facilities (8 in India, 2 in the US and 1 in Europe) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & Europe ensuring a strong global presence. Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
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    About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...

    ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships for product development, compliance, and secure logistics. ChemWerth accesses over 500 APIs and 30 manufacturing facilities across the US, Europe, India, and China, acts as a regulatory agent for 25+ FDA-approved facilities, sells 100+ products, and operates in 38 countries. In 2020, it filed its 500th DMF with the FDA . Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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    Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, impurities, metabolites, method development, advanced intermediates, and APIs for commercial launch. Focused on quality, reliability, and transparency, Nuray is a trusted partner in the global generic market. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...

    Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approval for synthetic and biotech APIs, CCSB has commercialized Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs with complete DMF or COS. It partners with leading drug companies to develop and produce specialty APIs using advanced fermentation and synthesis technologies in Taiwan. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    About the Company : Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuti...

    Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuticals Ingredients and their intermediates. Till date the company has invested around US $ 50M and has filed 23 US DMFs and 1 CEP with US and European Authority's respectively. The manufacturing facility is also approved by USFDA and WHO. We at Raks are dedicated to develop and manufacture active pharmaceutical ingredients and intermediates. We are committed to create value through intellectual property, quality systems and customer relation across the globe.
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    API Reference Price

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KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"7010016 4001328 ELTROMBOPAG OLAMINE 7010016 4001328 ELTROMBOPAG OLAMINE","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLUS CHEMICALS","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"15.90","actualQuantity":"15.9","unit":"KGS","unitRateFc":"12000","totalValueFC":"193025","currency":"USD","unitRateINR":"1039200","date":"09-Apr-2025","totalValueINR":"16523280","totalValueInUsd":"193025","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"9395791","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"BRANCH TEVA PHARMACEUTICALS INTL SC HLUESSELSTRASSE 12 JONA 8645, ., , Switzerland Switzerland","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"7010016 4001328 ELTROMBOPAG OLAMINE 7010016 4001328 ELTROMBOPAG OLAMINE","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLUS CHEMICALS","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"12000","totalValueFC":"242798.7","currency":"USD","unitRateINR":"1039200","date":"09-Apr-2025","totalValueINR":"20784000","totalValueInUsd":"242798.7","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"9395791","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"BRANCH TEVA PHARMACEUTICALS INTL SC HLUESSELSTRASSE 12 JONA 8645, ., , Switzerland Switzerland","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"7010016 4001328 ELTROMBOPAG OLAMINE 7010016 4001328 ELTROMBOPAG OLAMINE","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLUS CHEMICALS","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"12000","totalValueFC":"485597.4","currency":"USD","unitRateINR":"1039200","date":"09-Apr-2025","totalValueINR":"41568000","totalValueInUsd":"485597.4","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"9395791","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"BRANCH TEVA PHARMACEUTICALS INTL SC HLUESSELSTRASSE 12 JONA 8645, ., , Switzerland Switzerland","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"7010016 4001328 ELTROMBOPAG OLAMINE 7010016 ELTROMBOPAG OLAMINE","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLUS CHEMICALS","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"12000","totalValueFC":"728396.1","currency":"USD","unitRateINR":"1039200","date":"09-Apr-2025","totalValueINR":"62352000","totalValueInUsd":"728396.1","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"9395791","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"BRANCH TEVA PHARMACEUTICALS INTL SC HLUESSELSTRASSE 12 JONA 8645, ., , Switzerland Switzerland","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745001000,"product":"ELTROMBOPAG OLAMINE (VIDE RE IMPORT SB NO: 9808983 DT: 09-APR-25)ELTROMBOPAG OLAMINE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"HELM PHARMACEUTICALS GMBH","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"MSN LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"66.00","actualQuantity":"66","unit":"KGS","unitRateFc":"4600","totalValueFC":"306431","currency":"USD","unitRateINR":"397440","date":"19-Apr-2025","totalValueINR":"26231040","totalValueInUsd":"306431","indian_port":"Hyderabad Air","hs_no":"29163110","bill_no":"9598191","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"NORDKANALSTRABE 28, HAMBURG - 20097 GERMANY SDNF Germany","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"(100% EOU) (FOC) ELTROMBOPAG CHOLINE WS CODE.WS2536 (FOR RESEARCH & TESTING PURPOSE ONLY)(100% EOU) (FOC) ELTROMBOPAG CHOLINE WS CODE.WS2536 (FOR RES","address":"210 - 210A, GALLERIA, HIRANANDANI","city":"MUMBAI, MAHARASHTRA","supplier":"TAPI CROATIA INDUSTRIES LTD","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"ACTAVIS PHARMA DEVELOPMENT CENTRE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"100","unit":"MGS","unitRateFc":"0.1","totalValueFC":"11.7","currency":"USD","unitRateINR":"10.1","date":"13-Jun-2025","totalValueINR":"1006.3","totalValueInUsd":"11.7","indian_port":"Madras Air","hs_no":"29419090","bill_no":"2643752","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRUDNICKA CESTA 54 10291 PRIGORJE BRDOVECKO, CROATIA, CROATIA","customerAddress":"210 - 210A, GALLERIA, HIRANANDANI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756924200,"product":"(100% EOU) (FOC) ELTROMBOPAG OLAMINE WS2019 (FOR RESEARCH &TESTING PURPOSES ONLY)(100% EOU) (FOC) ELTROMBOPAG OLAMINE WS2019 (FOR RESEARCH &","address":"210 - 210A, GALLERIA, HIRANANDANI","city":"MUMBAI, MAHARASHTRA","supplier":"TAPI CROATIA INDUSTRIES LTD","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"ACTAVIS PHARMA DEVELOPMENT CENTRE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"50","unit":"MGS","unitRateFc":"0.2","totalValueFC":"10","currency":"USD","unitRateINR":"17.6","date":"04-Sep-2025","totalValueINR":"879","totalValueInUsd":"10","indian_port":"Madras Air","hs_no":"29339990","bill_no":"4291086","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRUDNICKA CESTA 54 10291 PRIGORJE BRDOVECKO, CROATIA, CROATIA","customerAddress":"210 - 210A, GALLERIA, HIRANANDANI"}]
    05-Jan-2022
    27-Feb-2026
    KGS
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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

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    01

    Brand Name : Promacta

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 557,676,106

    Year : 2023

    Prescribers : 5708

    Prescriptions : 39505

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 454,825,188

    Year : 2022

    Prescribers : 5150

    Prescriptions : 35692

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 389,486,269

    Year : 2021

    Prescribers : 4960

    Prescriptions : 32978

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 341,789,027

    Year : 2020

    Prescribers : 4616

    Prescriptions : 31379

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    Brand Name : Promacta

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 304,352,153

    Year : 2019

    Prescribers : 4977

    Prescriptions : 31057

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    Brand Name : Promacta

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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 424,909

    Year : 2018

    Prescribers : 35

    Prescriptions : 72

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    07

    Brand Name : Promacta

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    Company : Novartis

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    Drug Cost (USD) : 254,107,970

    Year : 2018

    Prescribers : 4752

    Prescriptions : 29029

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    08

    Brand Name : Promacta

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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 2,376,341

    Year : 2017

    Prescribers : 179

    Prescriptions : 413

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    Brand Name : Promacta

    Switzerland
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    IPhEB Russia
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    Brand Name : Promacta

    Switzerland
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    IPhEB Russia
    Not Confirmed
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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 189,364,721

    Year : 2017

    Prescribers : 3911

    Prescriptions : 24061

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    Brand Name : Promacta

    United Kingdom
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    IPhEB Russia
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    Brand Name : Promacta

    United Kingdom
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    IPhEB Russia
    Not Confirmed
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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 51,113,943

    Year : 2016

    Prescribers : 2229

    Prescriptions : 8487

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    Annual Reports

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    01

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine, Eltrombopag

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine, Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2020 Revenue in Millions : 1,738

    2019 Revenue in Millions : 1,416

    Growth (%) : 23

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    Brand Name : Promacta/Revolade

    Eltrombopag Olamine, Eltrombopag

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine, Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2021 Revenue in Millions : 2,016

    2020 Revenue in Millions : 1,738

    Growth (%) : 16

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    Brand Name : Promacta/Revolade

    Eltrombopag Olamine, Eltrombopag

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine, Eltrombopag

    Main Therapeutic Indication : Hematology

    Currency : USD

    2022 Revenue in Millions : 2,088

    2021 Revenue in Millions : 2,016

    Growth (%) : 4

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    Brand Name : Promacta/Revolade

    Eltrombopag Olamine, Eltrombopag

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine, Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2023 Revenue in Millions : 2,269

    2022 Revenue in Millions : 2,088

    Growth (%) : 9

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    Brand Name : Promacta/Revolade

    Eltrombopag Olamine, Eltrombopag

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine, Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2024 Revenue in Millions : 2,216

    2023 Revenue in Millions : 2,269

    Growth (%) : -2

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    06

    Brand Name : Promacta

    EltroMbopag diethanolamine salt

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    IPhEB Russia
    Not Confirmed

    Brand Name : Promacta

    United Kingdom
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    IPhEB Russia
    Not Confirmed

    GlaxoSmithKline

    EltroMbopag diethanolamine salt

    Main Therapeutic Indication : Oncology

    Currency : USD

    2014 Revenue in Millions : 24.20%

    2013 Revenue in Millions :

    Growth (%) :

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    07

    Brand Name : Revolade/Promacta

    EltroMbopag diethanolamine salt

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    IPhEB Russia
    Not Confirmed

    Brand Name : Revolade/Promacta

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Novartis

    EltroMbopag diethanolamine salt

    Main Therapeutic Indication : Oncology

    Currency : USD

    2015 Revenue in Millions : 0

    2014 Revenue in Millions : 402

    Growth (%) : New Launch

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    Brand Name : Revolade/Promacta

    Eltrombopag Olamine

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    IPhEB Russia
    Not Confirmed

    Brand Name : Revolade/Promacta

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Novartis

    Eltrombopag Olamine

    Main Therapeutic Indication : Oncology

    Currency : USD

    2016 Revenue in Millions : 635

    2015 Revenue in Millions : 402

    Growth (%) : 58

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    09

    Brand Name : Revolade/Promacta

    EltroMbopag diethanolamine salt

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    IPhEB Russia
    Not Confirmed

    Brand Name : Revolade/Promacta

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Novartis

    EltroMbopag diethanolamine salt

    Main Therapeutic Indication : Oncology

    Currency : USD

    2017 Revenue in Millions : 867

    2016 Revenue in Millions : 635

    Growth (%) : 37

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    10

    Brand Name : Revolade/Promacta

    EltroMbopag diethanolamine salt

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    IPhEB Russia
    Not Confirmed

    Brand Name : Revolade/Promacta

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Novartis

    EltroMbopag diethanolamine salt

    Main Therapeutic Indication : Oncology

    Currency : USD

    2018 Revenue in Millions : 1,174

    2017 Revenue in Millions : 867

    Growth (%) : 35%

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    APIs

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    Kazakhstan.png
    Eltrombopag Olamine (75 kg/ annum) API needed in Kazakhstan [ENA25550]
    A company that focuses on development & manufacturing of OSDs, semi solids and liquids is looking for suppliers of Eltrombopag Olamine (75 kg/ annum) API for commercial purposes. The suppliers must support this enquiry with CoA.
    16 Mar 2026

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    16 Mar 2026

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    16 Mar 2026

    VietNam.png
    Oral grade Eltrombopag Olamine API needed in Vietnam [ENA20223]
    A company that focuses on manufacturing and distribution of pharmaceutical products, medicinal herbs and medical equipment is looking for suppliers of Oral grade Eltrombopag Olamine API for commercial purposes. The required quantity is 250 g, 500 g, 1 kg, 2 kg & 5 kg. The suppliers must support this enquiry with DMF, GMP & CoA.
    09 Aug 2024

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    09 Aug 2024

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    Reply Comment (6)

    09 Aug 2024

    Oman.png
    USP/ Ph. Eur. Grade Eltrombopag Olamine API needed in Oman [ENA19636]
    A company that focuses on manufacturing and development of various finished formulation including oral solid, oral liquid & topical dosage forms is looking for suppliers of USP/ Ph. Eur. Grade Eltrombopag Olamine API for both development & commercial purposes. The required quantity 73 g for first year, 378 g for second year, 1.2 kg for third year, 1.5 kg for fourth year, 1.8 kg for fifth year, 2.2 kg for sixth year, 2.6 kg for seventh year & 2 kg for eighth year. The suppliers must support this enquiry with USDMF/ CEP, GMP & CoA.
    04 Jun 2024

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    04 Jun 2024

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    Reply Comment (8)

    04 Jun 2024

    india-flag.png
    Eltrombopag Olamine API needed in India [ENA19603]
    A CRO that provides formulation and analytical development services for OSDs, parenteral and liquid orals is looking for suppliers of Eltrombopag Olamine API. The required quantity is 1 kg for development and 30 kg for commercial purposes. The suppliers must support this enquiry with ODMF & CoA.
    29 May 2024

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    29 May 2024

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    29 May 2024

    india-flag.png
    Various APIs needed in India [ENA15174]
    A company that focuses on the manufacturing of pharmaceuticals is looking for suppliers of Various APIs. The suppliers must support this enquiry with CoA. 1. Asenapine API 2. Axitinib API 3. Fesoterodine Fumarate API 4. Eltrombopag Olamine API
    30 Sep 2022

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    30 Sep 2022

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    30 Sep 2022

    Kazakhstan.png
    Various APIs needed in Kazakhstan [ENA14980]
    A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Ramipril (MOQ) API 2. Irbesartan (1.5 MT/ annum) API 3. Telmisartan (1.3 MT/ annum) API 4. Sacubitril + Valsartan (1.5 MT/ annum) API 5. Eltrombopag Olamine (80 kg/ annum) API 6. Telmisartan Granules SD & DC (MOQ) API 7. Meglumine (MOQ) API
    09 Sep 2022

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    09 Sep 2022

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    Reply Comment (16)

    09 Sep 2022

    Canada.png
    Eltrombopag (20 kg/ annum) API needed in Canada [ENA14362]
    A CDMO that specializes in complex oral solid dose, liquids, semi-solids and nasal sprays for pharmaceutical Rx and OTC products is looking for suppliers of Eltrombopag (20 kg/ annum) API for commercial purpose. The suppliers must support this enquiry with USDMF.
    15 Jul 2022

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    15 Jul 2022

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    Reply Comment (7)

    15 Jul 2022

    Bangladesh.png
    Various APIs needed in Bangladesh [ENA13624]
    A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Pilocarpine (5 kg) API 2. Eltrombopag (2 kg) API
    13 May 2022

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    13 May 2022

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    Reply Comment (3)

    13 May 2022

    Bangladesh.png
    Eltrombopag Olamine API needed in Bangladesh [ENA13597]
    A company that deals in various pharmaceutical products is looking for suppliers of Eltrombopag Olamine API for commercial purpose. The suppliers must support this enquiry with CoA.
    10 May 2022

    Reply

    10 May 2022

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    Reply Comment (10)

    10 May 2022

    Egypt.png
    Various APIs needed in Egypt [ENA10114]
    A company that deals in various pharmaceutical products including hard gelatin capsules, tablets and dietary supplements is looking for suppliers of Various APIs for commercial purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA and GMP. 1. Betamethasone Sodium Phosphate API 2. Sterile Cyanocobalamin API 3. Ondansetron HCl API 4. Olsalazine API 5. Folic Acid API 6. Sodium Bicarbonate API 7. Orotic Acid API 8. Ceftolozane Sulfate API 9. Etoricoxib API 10. Thiamine API 11. Ascorbic Acid API 12. Eucalyptus Oil API 13. Eltrombopag Olamine API 14. Nicotinamide API 15. Benfotiamine API 16. Pyridoxine HCl API
    03 Apr 2021

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    03 Apr 2021

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    03 Apr 2021

    Only 10 entries up to this point, click to access all click full view read-more
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    Patents & EXCLUSIVITIES

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    US Patents

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    01

    TEVA PHARMS INC

    ELTROMBOPAG CHOLINE

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    Not Confirmed

    TEVA PHARMS INC

    Israel
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2038-11-05

    ELTROMBOPAG CHOLINE

    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

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    NOVARTIS

    ELTROMBOPAG OLAMINE

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    Not Confirmed

    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8062665*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22291

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2028-02-01

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    NOVARTIS

    ELTROMBOPAG OLAMINE

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    Not Confirmed

    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2027-08-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8828430

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 22291

    Patent Use Code : U-1306

    Delist Requested :

    Patent Use Description : TREATMENT OF THROMBOCY...

    Patent Expiration Date : 2027-08-01

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    NOVARTIS

    ELTROMBOPAG OLAMINE

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    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2026-01-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22291

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-01-13

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    NOVARTIS

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    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2026-01-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 207027

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-01-13

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    NOVARTIS

    ELTROMBOPAG OLAMINE

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    Not Confirmed

    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    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

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    07

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    IPhEB Russia
    Not Confirmed

    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 22291

    Patent Use Code : U-2452

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-07-13

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    08

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    IPhEB Russia
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    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

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    09

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    IPhEB Russia
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 22291

    Patent Use Code : U-930

    Delist Requested :

    Patent Use Description : TREATMENT OF IDIOPATHI...

    Patent Expiration Date : 2025-07-13

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    NOVARTIS

    ELTROMBOPAG OLAMINE

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    Not Confirmed

    NOVARTIS

    Switzerland
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    IPhEB Russia
    Not Confirmed

    Patent Expiration Date : 2026-01-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 207027

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-01-13

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    ABOUT THIS PAGE

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

    Eltrombopag manufacturers, exporters & distributors 1

    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.

    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.

    Promacta Manufacturers

    A Promacta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promacta, including repackagers and relabelers. The FDA regulates Promacta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promacta 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 Promacta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Promacta Suppliers

    A Promacta supplier is an individual or a company that provides Promacta active pharmaceutical ingredient (API) or Promacta finished formulations upon request. The Promacta suppliers may include Promacta API manufacturers, exporters, distributors and traders.

    click here to find a list of Promacta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Promacta USDMF

    A Promacta DMF (Drug Master File) is a document detailing the whole manufacturing process of Promacta active pharmaceutical ingredient (API) in detail. Different forms of Promacta DMFs exist exist since differing nations have different regulations, such as Promacta USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Promacta DMF submitted to regulatory agencies in the US is known as a USDMF. Promacta USDMF includes data on Promacta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Promacta USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Promacta suppliers with USDMF on PharmaCompass.

    Promacta 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 Promacta Drug Master File in Japan (Promacta JDMF) empowers Promacta 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 Promacta JDMF during the approval evaluation for pharmaceutical products. At the time of Promacta 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 Promacta suppliers with JDMF on PharmaCompass.

    Promacta KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Promacta Drug Master File in Korea (Promacta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Promacta. The MFDS reviews the Promacta KDMF as part of the drug registration process and uses the information provided in the Promacta KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Promacta 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 Promacta API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Promacta suppliers with KDMF on PharmaCompass.

    Promacta WC

    A Promacta written confirmation (Promacta WC) is an official document issued by a regulatory agency to a Promacta manufacturer, verifying that the manufacturing facility of a Promacta active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Promacta APIs or Promacta finished pharmaceutical products to another nation, regulatory agencies frequently require a Promacta WC (written confirmation) as part of the regulatory process.

    click here to find a list of Promacta suppliers with Written Confirmation (WC) on PharmaCompass.

    Promacta 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 Promacta as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Promacta 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 Promacta 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 Promacta and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Promacta NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Promacta suppliers with NDC on PharmaCompass.

    Promacta GMP

    Promacta 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 Promacta 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 Promacta GMP manufacturer or Promacta GMP API supplier for your needs.

    Promacta CoA

    A Promacta CoA (Certificate of Analysis) is a formal document that attests to Promacta's compliance with Promacta specifications and serves as a tool for batch-level quality control.

    Promacta CoA mostly includes findings from lab analyses of a specific batch. For each Promacta 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.

    Promacta may be tested according to a variety of international standards, such as European Pharmacopoeia (Promacta EP), Promacta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Promacta 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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