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    Synopsis

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    Chemistry

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    Also known as: 163451-81-8, 108605-62-5, Aubagio, Flucyamide, A77 1726, Hmr1726
    Molecular Formula
    C12H9F3N2O2
    Molecular Weight
    270.21  g/mol
    InChI Key
    UTNUDOFZCWSZMS-YFHOEESVSA-N
    FDA UNII
    1C058IKG3B
    Teriflunomide
    Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.
    Teriflunomide is a Pyrimidine Synthesis Inhibitor. The mechanism of action of teriflunomide is as a Dihydroorotate Dehydrogenase Inhibitor.
    1 2D Structure

    Teriflunomide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (Z)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide
    2.1.2 InChI
    InChI=1S/C12H9F3N2O2/c1-7(18)10(6-16)11(19)17-9-4-2-8(3-5-9)12(13,14)15/h2-5,18H,1H3,(H,17,19)/b10-7-
    2.1.3 InChI Key
    UTNUDOFZCWSZMS-YFHOEESVSA-N
    2.1.4 Canonical SMILES
    CC(=C(C#N)C(=O)NC1=CC=C(C=C1)C(F)(F)F)O
    2.1.5 Isomeric SMILES
    C/C(=C(\C#N)/C(=O)NC1=CC=C(C=C1)C(F)(F)F)/O
    2.2 Other Identifiers
    2.2.1 UNII
    1C058IKG3B
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (2z)-2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-2-butenamide

    2. (z)-2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-2-butenamide

    3. 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-2-butenamide

    4. 2-hydroxyethylidene-cyanoacetic Acid-4-trifluoromethyl Anilide

    5. A 1726

    6. A 771726

    7. A-771726

    8. A77 1726

    9. A771726

    10. Aubagio

    11. Hmr-1726

    12. Hmr1726

    13. Rs 61980

    2.3.2 Depositor-Supplied Synonyms

    1. 163451-81-8

    2. 108605-62-5

    3. Aubagio

    4. Flucyamide

    5. A77 1726

    6. Hmr1726

    7. Hmr-1726

    8. (z)-2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)but-2-enamide

    9. Hmr 1726

    10. A 771726

    11. A-771726

    12. Su 20

    13. A771726

    14. Teriflunomide(random Configuration)

    15. (z)-2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]but-2-enamide

    16. A 77-1726

    17. Leflunomide Related Compound B

    18. (e/z)-teriflunomide

    19. Chebi:68540

    20. 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-2-butenamide

    21. (2z)-2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]but-2-enamide

    22. (z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide

    23. 2-butenamide, 2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-, (2z)-

    24. 1c058ikg3b

    25. A77-1726

    26. Teriflunomide (usan)

    27. Teriflunomide [inn]

    28. 2-butenamide, 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-

    29. Teriflunomide [usan]

    30. 2-cyano-3-oh-n-(4-trifluoromethylphenyl)croton Amide

    31. 2-butenamide, 2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-

    32. (z)-2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)but-2-enamide.

    33. Mfcd00910058

    34. Rs 61980

    35. Teriflunomide [usan:inn]

    36. Teriflunomida

    37. Teriflunomidum

    38. Unii-1c058ikg3b

    39. 2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2-butenamide

    40. Malononitrilamide

    41. N-(4-trifluoromethylphenyl)-2-cyano-2-hydroxycrotonamide

    42. 2-hydroxyethylidene-cyanoacetic Acid-4-trifluoromethyl Anilide

    43. 2-butenamide, 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-, (2z)-

    44. A 1726

    45. A26

    46. Aubagio (tn)

    47. Su-0020

    48. Leflunomide Impurity B

    49. Rs-61980

    50. Leflunomide Ep Impurity B

    51. Teriflunomide [mi]

    52. (2z)-2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile

    53. Dimethyl Aprobarbital

    54. Schembl22661

    55. Teriflunomide [vandf]

    56. Teriflunomide(a-771726)

    57. Teriflunomide, A77 1726

    58. Teriflunomide [who-dd]

    59. Gtpl6844

    60. Dtxsid80893457

    61. Leflunomide Related Compound B Rs

    62. A77 1726 (e/z) Mixture

    63. Teriflunomide [orange Book]

    64. Teriflunomide [ep Monograph]

    65. Bdbm50018011

    66. Nsc766118

    67. S4169

    68. Zinc13512456

    69. Akos015994773

    70. Ccg-267145

    71. Db08880

    72. Le-0275

    73. Nsc-766118

    74. Ncgc00263218-07

    75. Ncgc00263218-13

    76. Ac-26446

    77. Hy-110159

    78. Cs-0033021

    79. Leflunomide Impurity B [ep Impurity]

    80. Sw219377-1

    81. T3287

    82. Leflunomide-d4 Metabolite (teriflunomide-d4)

    83. D10172

    84. Leflunomide Related Compound B [usp-rs]

    85. Ab01565775_02

    86. A801897

    87. A882574

    88. J-010046

    89. Q3077133

    90. Leflunomide Related Compound B [usp Impurity]

    91. N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide

    92. N-[4-(trifluoromethyl)phenyl]-2-cyano-3-hydroxycrotonamide

    93. 2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2z-butenamide

    94. (z)-2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2-butenamide

    95. 163451-81-8 (z Isomer) , 108605-62-5 (e/z Mixture)

    96. 2-butenamide, 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)-, (z)-

    97. A 77-1726;a771726;hmr1726;cas# 108605-62-5

    98. (2z)-2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]but-2-enamide (teriflunomide)

    99. 2-cyano-3-hydroxy-n-(4-(trifluoromethyl)phenyl)but-2-enamide (e/z)-mixture

    100. Leflunomide Related Compound B, United States Pharmacopeia (usp) Reference Standard

    101. A 1726, A77-1726, A771726, Flucyamide, Hmr 1726, N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotoamide, Su 20

    102. Teriflunomide; Leflunomide Usp Rc B; Cyano Keto Leflunomide Impurity; N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide; 2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2-beuteamide

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 270.21 g/mol
    Molecular Formula C12H9F3N2O2
    XLogP33.3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count2
    Exact Mass270.06161202 g/mol
    Monoisotopic Mass270.06161202 g/mol
    Topological Polar Surface Area73.1 Ų
    Heavy Atom Count19
    Formal Charge0
    Complexity426
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAubagio
    PubMed HealthTeriflunomide (By mouth)
    Drug ClassesCentral Nervous System Agent, Immune Modulator
    Active IngredientTeriflunomide
    Dosage FormTablet
    RouteOral
    Strength14mg; 7mg
    Market StatusPrescription
    CompanySanofi Aventis Us

    2 of 2  
    Drug NameAubagio
    PubMed HealthTeriflunomide (By mouth)
    Drug ClassesCentral Nervous System Agent, Immune Modulator
    Active IngredientTeriflunomide
    Dosage FormTablet
    RouteOral
    Strength14mg; 7mg
    Market StatusPrescription
    CompanySanofi Aventis Us

    4.2 Drug Indication

    Used in the treatment of relapsing forms of multiple sclerosis (MS).

    FDA Label

    AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Teriflunomide is an immunomodulatory agent that decreases the amount of activated CNS lymphocytes, which results in anti-inflammatory and antiproliferative effects.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TERIFLUNOMIDE
    5.3.2 FDA UNII
    1C058IKG3B
    5.3.3 Pharmacological Classes
    Pyrimidine Synthesis Inhibitor [EPC]; Dihydroorotate Dehydrogenase Inhibitors [MoA]
    5.4 ATC Code

    L04AA31

    L04AA31

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA31 - Teriflunomide

    5.5 Absorption, Distribution and Excretion

    Absorption

    After oral administration of teriflunomide, maximum plasma concentrations are reached, on average, in 1-4 hours.

    Route of Elimination

    Teriflunomide is eliminated unchanged and mainly through bile. Specifically 37.5% is eliminated in the feces and 22.6% in urine.

    Volume of Distribution

    After a single intravenous dose, the volume of distribution is 11 L.

    Clearance

    After a single IV dose, teriflunomide has a total body clearance of 30.5 mL/h.

    5.6 Metabolism/Metabolites

    Teriflunomide mainly undergoes hydrolyis to minor metabolites. Other minor metabolic pathways include oxidation, N-acetylation and sulfate conjugation. Teriflunomide is not metabolized by CYP450 or flavin monoamine oxidase.

    5.7 Biological Half-Life

    The median half-life is 18 to 19 days.

    5.8 Mechanism of Action

    The exact mechanism by which teriflunomide acts in MS is not known. What is known is that teriflunomide prevents pyrimidine synthesis by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, and this may be involved in its immunomodulatory effect in MS.

    API Reference Price

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FREE OF COST NCV","address":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR","city":"AHMEDABAD","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"#N\/A","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2.88","actualQuantity":"2.88","unit":"KGS","unitRateFc":"6800","totalValueFC":"19822.3","currency":"USD","unitRateINR":"512720","date":"10-Jan-2022","totalValueINR":"1476633.6","totalValueInUsd":"19822.3","indian_port":"BOMBAY AIR","hs_no":"29269000","bill_no":"7014692","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643221800,"product":"TERIFLUNOMIDE","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"VERBEN S.A.,","supplierCountry":"ARGENTINA","foreign_port":"#N\/A","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"4.65","actualQuantity":"4.645","unit":"KGS","unitRateFc":"6000","totalValueFC":"28171.8","currency":"USD","unitRateINR":"451800","date":"27-Jan-2022","totalValueINR":"2098611","totalValueInUsd":"28171.8","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"7251324","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1696012200,"product":"TERIFLUNOMIDE (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"VERBEN S.A.,","supplierCountry":"SWITZERLAND","foreign_port":"BUENOS AIRES, BA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"33.77","actualQuantity":"33.77","unit":"KGS","unitRateFc":"2950","totalValueFC":"100871.8","currency":"USD","unitRateINR":"247947.5","date":"30-Sep-2023","totalValueINR":"8373187.08","totalValueInUsd":"100871.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"8090130","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"VIA F. PELLI 17, P.O BOX 6901LUGANO BRANCHSDNF CH","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708885800,"product":"TERIFLUNOMIDE (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"VERBEN S.A.,","supplierCountry":"SWITZERLAND","foreign_port":"BUENOS AIRES, BA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"39.60","actualQuantity":"39.6","unit":"KGS","unitRateFc":"3500","totalValueFC":"140147.2","currency":"USD","unitRateINR":"293650","date":"26-Feb-2024","totalValueINR":"11628540","totalValueInUsd":"140147.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2302626","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"VIA F. PELLI 17, P.O BOX 6901LUGANO BRANCHSDNF CH","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718562600,"product":"TERIFLUNOMIDE (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"VERBEN S.A.,","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES, BA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"34.10","actualQuantity":"34.1","unit":"KGS","unitRateFc":"2750","totalValueFC":"94696.8","currency":"USD","unitRateINR":"231825","date":"17-Jun-2024","totalValueINR":"7905232.5","totalValueInUsd":"94696.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4041940","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"VIA F. PELLI 17, P.O BOX 6901LUGANO BRANCHSDNF CH","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720981800,"product":"TERIFLUNOMIDE (CAS NO: 163451-81-8) (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"VERBEN S.A.","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES, BA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"37.50","actualQuantity":"37.5","unit":"KGS","unitRateFc":"2750","totalValueFC":"104184.6","currency":"USD","unitRateINR":"232237.5","date":"15-Jul-2024","totalValueINR":"8708906.25","totalValueInUsd":"104184.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4514257","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"VIA F PELLI 17 PO BOX6900 LUGANO- SWITZERLANDSDNF CH","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"(N.C.V.) 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    18-Mar-2021
    27-Dec-2024
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    DOSAGE - TABLET;ORAL - 14MG

    USFDA APPLICATION NUMBER - 202992

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    DOSAGE - TABLET;ORAL - 7MG

    USFDA APPLICATION NUMBER - 202992

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    ABOUT THIS PAGE

    Teriflunomide Manufacturers

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

    Teriflunomide Suppliers

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

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

    Teriflunomide USDMF

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

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

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

    Teriflunomide CEP

    A Teriflunomide CEP of the European Pharmacopoeia monograph is often referred to as a Teriflunomide Certificate of Suitability (COS). The purpose of a Teriflunomide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Teriflunomide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Teriflunomide to their clients by showing that a Teriflunomide CEP has been issued for it. The manufacturer submits a Teriflunomide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Teriflunomide CEP holder for the record. Additionally, the data presented in the Teriflunomide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Teriflunomide DMF.

    A Teriflunomide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Teriflunomide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Teriflunomide suppliers with CEP (COS) on PharmaCompass.

    Teriflunomide WC

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

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

    Teriflunomide 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 Teriflunomide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Teriflunomide GMP

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

    Teriflunomide CoA

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

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

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