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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

    API Reference Price

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    05-Jan-2021
    19-Feb-2025
    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

    USFDA APPLICATION NUMBER - 22291

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    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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    US Patents

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    01

    TEVA PHARMS INC

    ELTROMBOPAG CHOLINE

    arrow
    Interphex
    Not Confirmed

    TEVA PHARMS INC

    Israel
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    Interphex
    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-3938

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2038-11-05

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    02

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    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

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    03

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2027-08-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8052994

    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

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    04

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    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

    blank

    Portfolio PDF

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    Digital Content

    Website

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    05

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 207027

    Patent Use Code : U-1575

    Delist Requested :

    Patent Use Description : PATIENTS WITH SEVERE A...

    Patent Expiration Date : 2025-07-13

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    06

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2027-08-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8062665

    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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    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    07

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8052994*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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    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    08

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2027-08-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8062665

    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

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    Portfolio PDF

    Product Web Link

    Virtual Booth

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    09

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    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

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    NOVARTIS

    ELTROMBOPAG OLAMINE

    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    Peptide-Based Therapeutics Summit
    Not Confirmed

    Patent Expiration Date : 2025-07-13

    ELTROMBOPAG OLAMINE

    US Patent Number : 7547719

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 207027

    Patent Use Code : U-1306

    Delist Requested :

    Patent Use Description : TREATMENT OF THROMBOCY...

    Patent Expiration Date : 2025-07-13

    blank

    Portfolio PDF

    Product Web Link

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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.

    Revolade Manufacturers

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

    Revolade Suppliers

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

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

    Revolade USDMF

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

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

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

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

    Revolade KDMF

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

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

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

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

    Revolade WC

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

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

    Revolade 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 Revolade as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Revolade GMP

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

    Revolade CoA

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

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

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