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    Chemistry

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    Also known as: 54965-24-1, Zitazonium, Istubal, Kessar, Zemide, Tamoxifen (citrate)
    Molecular Formula
    C32H37NO8
    Molecular Weight
    563.6  g/mol
    InChI Key
    FQZYTYWMLGAPFJ-OQKDUQJOSA-N
    FDA UNII
    7FRV7310N6
    Tamoxifen Citrate
    One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.
    1 2D Structure

    Tamoxifen Citrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[4-[(Z)-1,2-diphenylbut-1-enyl]phenoxy]-N,N-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid
    2.1.2 InChI
    InChI=1S/C26H29NO.C6H8O7/c1-4-25(21-11-7-5-8-12-21)26(22-13-9-6-10-14-22)23-15-17-24(18-16-23)28-20-19-27(2)3;7-3(8)1-6(13,5(11)12)2-4(9)10/h5-18H,4,19-20H2,1-3H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/b26-25-;
    2.1.3 InChI Key
    FQZYTYWMLGAPFJ-OQKDUQJOSA-N
    2.1.4 Canonical SMILES
    CCC(=C(C1=CC=CC=C1)C2=CC=C(C=C2)OCCN(C)C)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CC/C(=C(\C1=CC=CC=C1)/C2=CC=C(C=C2)OCCN(C)C)/C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    7FRV7310N6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Citrate, Tamoxifen

    2. Ici 46,474

    3. Ici 46474

    4. Ici 47699

    5. Ici-46,474

    6. Ici-46474

    7. Ici-47699

    8. Ici46,474

    9. Ici46474

    10. Ici47699

    11. Nolvadex

    12. Novaldex

    13. Soltamox

    14. Tamoxifen

    15. Tomaxithen

    16. Zitazonium

    2.3.2 Depositor-Supplied Synonyms

    1. 54965-24-1

    2. Zitazonium

    3. Istubal

    4. Kessar

    5. Zemide

    6. Tamoxifen (citrate)

    7. Tamoxifen Citrate Salt

    8. Nourytam

    9. Tamofene

    10. Tomaxasta

    11. Ici 46474

    12. Ici 46,474

    13. Ici 46474 Citrate

    14. Ici-46474

    15. Nsc-180973

    16. Nsc-757345

    17. Tamoxifen Citrate (nolvadex)

    18. 54965-24-1 (citrate)

    19. 7frv7310n6

    20. I.c.i.46474 Citrate

    21. Nsc180973

    22. Ncgc00024928-06

    23. Cas-54965-24-1

    24. Dsstox_cid_1301

    25. (z)-2-(p-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethylethylamine Citrate (1:1)

    26. Dsstox_rid_76068

    27. Dsstox_gsid_21301

    28. Ethanamine, 2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-, (z)-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    29. Caditam

    30. Farmifeno

    31. Ginarsan

    32. Jenoxifen

    33. Ledertam

    34. Nourytan

    35. Noxitem

    36. Oncotam

    37. Tafoxen

    38. Tamofen

    39. Tamoxasta

    40. Terimon

    41. Zynoplex

    42. Emblon

    43. Genox

    44. Nolgen

    45. Noltam

    46. Tamax

    47. Tamoxifencitrate

    48. Tamox-puren

    49. (z)-2-(4-(1,2-diphenylbut-1-en-1-yl)phenoxy)-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate

    50. 2-[4-[(z)-1,2-diphenylbut-1-enyl]phenoxy]-n,n-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

    51. Ethanamine, 2-(4-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    52. Smr000677949

    53. Z-tamoxifen Citrate

    54. Sr-01000075523

    55. Unii-7frv7310n6

    56. Ccris 6718

    57. Tamoxifeni Citras

    58. Nolvadex (tn)

    59. Soltamox (tn)

    60. 2-{4-[(1z)-1,2-diphenylbut-1-en-1-yl]phenoxy}-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt)

    61. Prestwick_458

    62. Einecs 259-415-2

    63. Tamoxifen Citrate [usan:usp:jan]

    64. Mfcd00058321

    65. Tamoxifen (nolvadex)

    66. Tamoxifen Citrate,(s)

    67. Tamoxifen, Citrate Salt

    68. Lopac-t-9262

    69. Tamoxifen Z-isomer Citrate

    70. Chembl786

    71. Schembl6365

    72. Mls001055370

    73. Mls002154210

    74. Spectrum1500557

    75. Nolvadex (tn) (astrazeneca)

    76. Tamoxifen Citrate [mi]

    77. Tamoxifen Citrate [jan]

    78. Dtxsid8021301

    79. Tamoxifen Citrate (jp17/usp)

    80. Tamoxifen Citrate [usan]

    81. Hms500m20

    82. Tamoxifen Citrate Salt, >=99%

    83. Tamoxifen Citrate [vandf]

    84. Tamoxifen Citrate [mart.]

    85. Hms1568m14

    86. Hms1921c13

    87. Hms2092k17

    88. Hms2095m14

    89. Hms2232e08

    90. Hms3263b08

    91. Hms3675p04

    92. Hms3712m14

    93. Pharmakon1600-01500557

    94. Tamoxifen Citrate [usp-rs]

    95. Tamoxifen Citrate [who-dd]

    96. Tamoxifen Citrate [who-ip]

    97. Ex-a5777

    98. Hydroxypropane-1,2,3-tricarboxylate

    99. Tox21_110938

    100. Tox21_202070

    101. Tox21_300274

    102. Tox21_501203

    103. Ccg-39629

    104. Nsc757345

    105. S1238

    106. S1972

    107. Akos005111126

    108. Tox21_110938_1

    109. Cs-1852

    110. Ks-5046

    111. Lp01203

    112. Tamoxifen Citrate [orange Book]

    113. Tamoxifen Citrate [ep Monograph]

    114. Ncgc00016206-01

    115. Ncgc00016206-02

    116. Ncgc00016206-03

    117. Ncgc00016206-04

    118. Ncgc00016206-05

    119. Ncgc00016206-06

    120. Ncgc00024928-02

    121. Ncgc00024928-23

    122. Ncgc00094450-01

    123. Ncgc00094450-02

    124. Ncgc00094450-03

    125. Ncgc00094450-04

    126. Ncgc00254000-01

    127. Ncgc00259619-01

    128. Ncgc00261888-01

    129. Tamoxifen Citrate [usp Monograph]

    130. Tamoxifeni Citras [who-ip Latin]

    131. Hy-13757

    132. Bcp0726000223

    133. Tamoxifen Citrate - Cas 54965-24-1

    134. Eu-0101203

    135. Sw219368-1

    136. T2510

    137. (z)-2-(4-(1,2-diphenylbut-1-enyl)phenoxy)

    138. A19582

    139. D00966

    140. T 9262

    141. 965t241

    142. Q-201776

    143. Sr-01000075523-1

    144. Sr-01000075523-3

    145. Sr-01000075523-5

    146. Sr-01000075523-6

    147. Q27108378

    148. Sr-01000075523-10

    149. (z)-1-(4-dimethylaminoethoxyphenyl)-1,2-diphenyl-1-butene Citrate

    150. Tamoxifen Citrate, European Pharmacopoeia (ep) Reference Standard

    151. (z)-2-(4-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethylethanamine,citrate

    152. (z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethylethanamine Citrate

    153. Tamoxifen Citrate, United States Pharmacopeia (usp) Reference Standard

    154. (z)-2-[ P-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethylamine Citrate (1:1)

    155. (z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-ethanamine Cirtrate (1:1)

    156. Tamoxifen Citrate For Performance Test, European Pharmacopoeia (ep) Reference Standard

    157. (2-{4-[1,2-diphenylbut-1-en-1-yl]phenoxy}ethyl)dimethylamine; 2-hydroxypropane-1,2,3-tricarboxylic Acid

    158. (z)-(2-(4-(1,2-diphenylbut-1-enyl)phenoxy)ethyl)dimethylammonium Dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

    159. (z)-2-(4-(1,2-diphenylbut-1-enyl)phenoxy)-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate

    160. {2-[4-(1,2-diphenyl-1-buten-1-yl)phenoxy]ethyl}dimethylamine 2-hydroxy-1,2,3-propanetricarboxylate Salt

    161. Ethanamine, 2-(4-((1z)-1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    162. Ethanamine,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 563.6 g/mol
    Molecular Formula C32H37NO8
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count13
    Exact Mass563.25191714 g/mol
    Monoisotopic Mass563.25191714 g/mol
    Topological Polar Surface Area145 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity690
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTamoxifen citrate
    Drug LabelNOLVADEX (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as:...
    Active IngredientTamoxifen citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 10mg base
    Market StatusPrescription
    CompanyTeva; Actavis Labs Fl; Apotex; Teva Pharms; Mylan

    2 of 2  
    Drug NameTamoxifen citrate
    Drug LabelNOLVADEX (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as:...
    Active IngredientTamoxifen citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 10mg base
    Market StatusPrescription
    CompanyTeva; Actavis Labs Fl; Apotex; Teva Pharms; Mylan

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents, Hormonal

    Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)

    Bone Density Conservation Agents

    Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

    Estrogen Antagonists

    Compounds which inhibit or antagonize the action or biosynthesis of estrogenic compounds. (See all compounds classified as Estrogen Antagonists.)

    Selective Estrogen Receptor Modulators

    A structurally diverse group of compounds distinguished from ESTROGENS by their ability to bind and activate ESTROGEN RECEPTORS but act as either an agonist or antagonist depending on the tissue type and hormonal milieu. They are classified as either first generation because they demonstrate estrogen agonist properties in the ENDOMETRIUM or second generation based on their patterns of tissue specificity. (Horm Res 1997;48:155-63) (See all compounds classified as Selective Estrogen Receptor Modulators.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Selective Estrogen Receptor Modulators [MoA]; Estrogen Agonist/Antagonist [EPC]

    API Reference Price

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SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"TAMOXIFEN CITRATE USP (CAS NO:54965-24-1)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"497.80","actualQuantity":"497.8","unit":"KGS","unitRateFc":"540","totalValueFC":"293855.2","currency":"EUR","unitRateINR":"49815","date":"14-Nov-2024","totalValueINR":"24797907","totalValueInUsd":"293855.2","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"6675660","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA RIVOLTANA KM 6\/7 RODANO MI 2 0053 ITALY SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"TAMOXIFEN CITRATE TAMOXIFEN CITRATE","address":"SECOND FLOOR, BLOCK-III,MY HOME HUB","city":"HYDERABAD, AP","supplier":"CHEMISCHE FABRIK BERG","supplierCountry":"GERMANY","foreign_port":"LEIPZIG\/HALLE","customer":"GRANULES INDIA LIMITED","customerCountry":"INDIA","quantity":"8.42","actualQuantity":"8.42","unit":"KGS","unitRateFc":"604.6","totalValueFC":"5131.6","currency":"USD","unitRateINR":"51784.5","date":"19-Dec-2024","totalValueINR":"436025.49","totalValueInUsd":"5131.6","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"7331285","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"LEIPZIG\/HALLE","supplierAddress":"MAINTHALSTRASSE 3 06749 BITTERFELD- WOLFEN SDNF Germany","customerAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737311400,"product":"TAMOXIFEN CITRATE MILLED A TAMOXIFEN CITRATE MILLED A","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"EXCELLA GMBH","supplierCountry":"GERMANY","foreign_port":"DUESSELDORF","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"593.5","totalValueFC":"89921.7","currency":"EUR","unitRateINR":"51692.5","date":"20-Jan-2025","totalValueINR":"7753875","totalValueInUsd":"89921.7","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"7891565","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DUESSELDORF","supplierAddress":"NURNBERGER STR.12 D-90537 FEUCHT GERMANY","customerAddress":"407\/408,SHARDA CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737484200,"product":"TAMOXIFEN CITRATE (TEST LIC. # SW\/OD\/11\/2024\/000008216 DTD.17.12.2024)TAMOXIFEN CITRATE (TEST LIC. # SW\/OD\/11\/2024\/000008216 DTD.","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"CHEMISCHE FABRIK BERG","supplierCountry":"GERMANY","foreign_port":"LEIPZIG\/HALLE","customer":"WOCKHARDT","customerCountry":"INDIA","quantity":"5.05","actualQuantity":"5.05","unit":"KGS","unitRateFc":"634.8","totalValueFC":"3238","currency":"EUR","unitRateINR":"55288.5","date":"22-Jan-2025","totalValueINR":"279206.93","totalValueInUsd":"3238","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"7923332","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"LEIPZIG\/HALLE","supplierAddress":"MAINTHALSTRASSE 3 064749 BITTERFELD #NAME? SDNF","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"TAMOXIFEN CITRATE USP (CAS NO:54965-24-1) TAMOXIFEN CITRATE USP (CAS NO:54965-24-1)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"334.70","actualQuantity":"334.7","unit":"KGS","unitRateFc":"568","totalValueFC":"191827.7","currency":"EUR","unitRateINR":"49842","date":"22-Feb-2025","totalValueINR":"16682117.4","totalValueInUsd":"191827.7","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"8501210","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20053 RODANO (MI) SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"}]
    04-Jan-2021
    29-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17970

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    DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17970

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    DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/10ML

    USFDA APPLICATION NUMBER - 21807

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    ABOUT THIS PAGE

    Looking for 54965-24-1 / Tamoxifen Citrate API manufacturers, exporters & distributors?

    Tamoxifen Citrate manufacturers, exporters & distributors 1

    92

    PharmaCompass offers a list of Tamoxifen Citrate 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 Tamoxifen Citrate manufacturer or Tamoxifen Citrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tamoxifen Citrate manufacturer or Tamoxifen Citrate supplier.

    PharmaCompass also assists you with knowing the Tamoxifen Citrate API Price utilized in the formulation of products. Tamoxifen Citrate API Price is not always fixed or binding as the Tamoxifen Citrate Price is obtained through a variety of data sources. The Tamoxifen Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Tamoxifen Citrate

    Synonyms

    54965-24-1, Zitazonium, Istubal, Kessar, Zemide, Tamoxifen (citrate)

    Cas Number

    54965-24-1

    Unique Ingredient Identifier (UNII)

    7FRV7310N6

    About Tamoxifen Citrate

    One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

    Tamax Manufacturers

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

    Tamax Suppliers

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

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

    Tamax USDMF

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

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

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

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

    Tamax KDMF

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

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

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

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

    Tamax CEP

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

    A Tamax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamax 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 Tamax suppliers with CEP (COS) on PharmaCompass.

    Tamax 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 Tamax as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tamax GMP

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

    Tamax CoA

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

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

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