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    Chemistry

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    Also known as: 36282-47-0, Contramal, (+)-tramadol hydrochloride, Tradonal, 148229-78-1, Cis-tramadol hydrochloride
    Molecular Formula
    C16H26ClNO2
    Molecular Weight
    299.83  g/mol
    InChI Key
    PPKXEPBICJTCRU-XMZRARIVSA-N
    FDA UNII
    9N7R477WCK
    Tramadol Hydrochloride
    A narcotic analgesic proposed for severe pain. It may be habituating.
    1 2D Structure

    Tramadol Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride
    2.1.2 InChI
    InChI=1S/C16H25NO2.ClH/c1-17(2)12-14-7-4-5-10-16(14,18)13-8-6-9-15(11-13)19-3;/h6,8-9,11,14,18H,4-5,7,10,12H2,1-3H3;1H/t14-,16+;/m1./s1
    2.1.3 InChI Key
    PPKXEPBICJTCRU-XMZRARIVSA-N
    2.1.4 Canonical SMILES
    CN(C)CC1CCCCC1(C2=CC(=CC=C2)OC)O.Cl
    2.1.5 Isomeric SMILES
    CN(C)C[C@H]1CCCC[C@@]1(C2=CC(=CC=C2)OC)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    9N7R477WCK
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Adolonta

    2. Amadol

    3. Biodalgic

    4. Biokanol

    5. Contramal

    6. Jutadol

    7. K 315

    8. K-315

    9. K315

    10. Mtw Tramadol

    11. Mtw-tramadol

    12. Mtwtramadol

    13. Nobligan

    14. Prontofort

    15. Ranitidin 1a Pharma

    16. Takadol

    17. Theradol

    18. Tiral

    19. Topalgic

    20. Tradol

    21. Tradol Puren

    22. Tradol-puren

    23. Tradolpuren

    24. Tradonal

    25. Tralgiol

    26. Trama 1a Pharma

    27. Trama Abz

    28. Trama Dorsch

    29. Trama Kd

    30. Trama-dorsch

    31. Tramabeta

    32. Tramadin

    33. Tramadoc

    34. Tramadol

    35. Tramadol 1a

    36. Tramadol Acis

    37. Tramadol Al

    38. Tramadol Asta Medica

    39. Tramadol Basics

    40. Tramadol Bayvit

    41. Tramadol Bexal

    42. Tramadol Cinfa

    43. Tramadol Dolgit

    44. Tramadol Edigen

    45. Tramadol Hameln

    46. Tramadol Heumann

    47. Tramadol Kern

    48. Tramadol Lichtenstein

    49. Tramadol Lindo

    50. Tramadol Mabo

    51. Tramadol Normon

    52. Tramadol Pb

    53. Tramadol Ratiopharm

    54. Tramadol Stada

    55. Tramadol-dolgit

    56. Tramadol-hameln

    57. Tramadol-ratiopharm

    58. Tramadoldolgit

    59. Tramadolhameln

    60. Tramadolor

    61. Tramadolratiopharm

    62. Tramadorsch

    63. Tramadura

    64. Tramagetic

    65. Tramagit

    66. Tramake

    67. Tramal

    68. Tramex

    69. Tramundin

    70. Trasedal

    71. Ultram

    72. Xymel 50

    73. Zamudol

    74. Zumalgic

    75. Zydol

    76. Zytram

    2.3.2 Depositor-Supplied Synonyms

    1. 36282-47-0

    2. Contramal

    3. (+)-tramadol Hydrochloride

    4. Tradonal

    5. 148229-78-1

    6. Cis-tramadol Hydrochloride

    7. Tramadol Hcl

    8. Amadol

    9. Zydol

    10. Conzip

    11. 22204-88-2

    12. Tramal

    13. Zydol Hydrochloride

    14. Crispin

    15. Ryzolt

    16. Cg-315e

    17. 9n7r477wck

    18. 194602-08-9

    19. Bellatram

    20. Omnidol

    21. Zumatran

    22. Chebi:75733

    23. Radol

    24. Tadol

    25. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride

    26. Melanate

    27. Poltram

    28. Tramadex

    29. Tramagetic

    30. Tramazac

    31. U-26225a

    32. Dolana

    33. Mabron

    34. Trabar

    35. Tramed

    36. Tramol

    37. Tridol

    38. U-26,225a

    39. Tradol-puren

    40. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

    41. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, (1r,2r)-rel-

    42. Zamudol

    43. Zertane

    44. Tramadolhydrochloride

    45. Adolanta

    46. Cemadol

    47. Synapryn

    48. Tridural

    49. Rybix

    50. Viotra

    51. Tramal Retard

    52. Ira-tramadol

    53. Ultram Er

    54. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-,hydrochloride, (1r,2r)-rel-

    55. Rybix Odt

    56. Cg 315

    57. Smr000449308

    58. Tramadol Hydrochloride Civ

    59. Tramadol Related Compound A

    60. Zydol Xl 150

    61. Einecs 252-950-2

    62. Unii-9n7r477wck

    63. Tramundin

    64. Cg-315

    65. Nih-10969

    66. Nsc-759105

    67. (1r,2r)-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

    68. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol Hydrochloride

    69. Nih 10969

    70. Ultram (tn)

    71. Qdolo

    72. Tramadole Hydrochloride

    73. Tramadol/hcl

    74. Tramadol Hydrochloride [usan:usp:jan]

    75. (+-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride

    76. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-

    77. Schembl41748

    78. (r,r)-tramadol Hydrochloride

    79. 53611-16-8

    80. Mls000758218

    81. Mls001424208

    82. Chembl1200336

    83. Dtxsid7023691

    84. Hy-b0582a

    85. Tramadol Hydrochloride, Ep Grade

    86. Dtxsid60933340

    87. (1rs,2sr)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

    88. Tramadol Hydrochloride [mi]

    89. 3,3,4,4-terephthaloydiphthalicacid

    90. Tramadol Hydrochloride (jp17/usp)

    91. Tramadol Hydrochloride [jan]

    92. Ac-796

    93. Mfcd00798507

    94. Tramadol Hydrochloride [hsdb]

    95. Tramadol Hydrochloride [usan]

    96. Tramadol Hydrochloride [vandf]

    97. (+)-(1r,2r)-tramadol Hydrochloride

    98. Akos015907739

    99. Tramadol Hydrochloride [mart.]

    100. Ccg-101135

    101. Ks-1124

    102. Nc00385

    103. Nsc 759105

    104. Tramadol Hydrochloride [who-dd]

    105. (+-)-cis-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

    106. Bt162445

    107. Tramadol Hydrochloride [orange Book]

    108. Tramadol Hydrochloride Civ [usp-rs]

    109. Tramadol Hydrochloride, >=99.0% (hplc)

    110. Tramadol Hydrochloride [ep Monograph]

    111. Tramadol Hydrochloride [usp Monograph]

    112. D01355

    113. Tramadol Hydrochloride, >=98% (hplc), Solid

    114. Ultracet Component Tramadol Hydrochloride

    115. 204t882

    116. Sr-01000759320

    117. Tramadol Hydrochloride Component Of Ultracet

    118. Q-201847

    119. Sr-01000759320-5

    120. Q27145507

    121. Tramadol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    122. (+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

    123. Tramadol Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    124. Tramadol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    125. Tramadol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    126. (+/-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride

    127. (1r,2r)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol Hydrochloride

    128. [(1r,2r)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]-n,n-dimethylmethanaminium Chloride

    129. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol--hydrogen Chloride (1/1)

    130. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-(+-)-

    131. Cis-tramadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    132. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-, (1r,2r)-, Hydrochloride (1:1)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 299.83 g/mol
    Molecular Formula C16H26ClNO2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass299.1652068 g/mol
    Monoisotopic Mass299.1652068 g/mol
    Topological Polar Surface Area32.7 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity282
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameConzip
    PubMed HealthTramadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl...
    Active IngredientTramadol hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength300mg; 200mg; 100mg; 150mg
    Market StatusPrescription
    CompanyCipher Pharms

    2 of 6  
    Drug NameTramadol hydrochloride
    PubMed HealthTramadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelTramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu...
    Active IngredientTramadol hydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength200mg; 300mg; 100mg; 50mg
    Market StatusPrescription
    CompanyAnchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm;

    3 of 6  
    Drug NameUltram er
    Drug LabelULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The...
    Active IngredientTramadol hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength200mg; 300mg; 100mg
    Market StatusPrescription
    CompanyValeant Intl

    4 of 6  
    Drug NameConzip
    PubMed HealthTramadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl...
    Active IngredientTramadol hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength300mg; 200mg; 100mg; 150mg
    Market StatusPrescription
    CompanyCipher Pharms

    5 of 6  
    Drug NameTramadol hydrochloride
    PubMed HealthTramadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelTramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu...
    Active IngredientTramadol hydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength200mg; 300mg; 100mg; 50mg
    Market StatusPrescription
    CompanyAnchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm;

    6 of 6  
    Drug NameUltram er
    Drug LabelULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The...
    Active IngredientTramadol hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength200mg; 300mg; 100mg
    Market StatusPrescription
    CompanyValeant Intl

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Analgesics, Opioid

    Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

    Narcotics

    Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

    API Reference Price

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AG","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"JOHNSON & JOHNSON PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"71.1","totalValueFC":"161126.2","currency":"EURO","unitRateINR":"6725.4","date":"27-Jun-2024","totalValueINR":"13450723.2","totalValueInUsd":"161126.2","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"4216823","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"TSCHACHEN 2 CH 8756 MITLODI SWITZERLA ND , , SwitzerlandSDNF Switzerland","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"TRAMADOL HYDROCHLORIDE-TRAMADOL HCL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"WAVELENGTH ENTERPRISES LTD","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"785.64","actualQuantity":"785.635","unit":"KGS","unitRateFc":"107.5","totalValueFC":"85433.9","currency":"USD","unitRateINR":"9121.4","date":"17-Aug-2024","totalValueINR":"7166071.45","totalValueInUsd":"85433.9","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"5105418","productDescription":"API","marketType":"","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"94 Shlomo Shmeltzer Road, Petach-Tikva. P.O.Box 3158, 4970602 Israel.Israel Israel","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"TRAMADOL HYDROCHLORIDE-TRAMADOL HCL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"WAVELENGTH ENTERPRISES LTD","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"786.32","actualQuantity":"786.32","unit":"KGS","unitRateFc":"107.5","totalValueFC":"85508.4","currency":"USD","unitRateINR":"9121.4","date":"17-Aug-2024","totalValueINR":"7172319.59","totalValueInUsd":"85508.4","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"5105769","productDescription":"API","marketType":"","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"94 Shlomo Shmeltzer Road, Petach-Tikva. P.O.Box 3158, 4970602 Israel.SDNF Israel","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734028200,"product":"TRAMADOLIJEV KLORID (TRAMADOL HYDROCHLORIDE)","address":"2ND FLOOR, SERENE CHAMBERS,","city":"HYDEABAD,TELANGANA","supplier":"KRKA D D NOVO MESTO","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA","customer":"LAURUS LABS LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"97.6","totalValueFC":"196856.6","currency":"USD","unitRateINR":"8363.4","date":"13-Dec-2024","totalValueINR":"16726703","totalValueInUsd":"196856.6","indian_port":"Vizag-APIICL SEZ","hs_no":"29420090","bill_no":"1001145","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA","supplierAddress":"SMARJESKA CESTA 6 8501 NOVO MESTO SI","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741977000,"product":"TRAMADOL HYDROCHLORIDE 71UM (TRADE SAMPLE)(IMPORTED VIDE CBNCERTIFICATE NO.P-IMP-10120\/2025 DT.26.02.2025) (01NOS)DRUG TEST LIC NO SW\/OD\/11\/2025\/000009881 DT 20\/02\/2025","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"PROTO CHEMICALS AG","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"TITAN LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"626.1","totalValueFC":"1269.3","currency":"EURO","unitRateINR":"54970","date":"15-Mar-2025","totalValueINR":"109940","totalValueInUsd":"1269.3","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8899789","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"TSCHACHEN 2, CH-8756 MITLOEDI (GLAR US-SUED) Mitlodi, , Switzerland SDNF Switzerland","customerAddress":"102,TITAN HOUSE,60 FEET RD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"TRAMADOL HYDROCHLORIDE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"LUPIN LTD","supplierCountry":"INDIA","foreign_port":"MADC LTD.","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"10.75","actualQuantity":"10.75","unit":"KGS","unitRateFc":"54.4","totalValueFC":"590.2","currency":"USD","unitRateINR":"4700","date":"29-Apr-2025","totalValueINR":"50525","totalValueInUsd":"590.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29221990","bill_no":"9768487","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADC LTD.","supplierAddress":"P.No.-M2 M2-A, Phase II INDORE SPECIAL ECONOMIC ZONE SDNF India","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745951400,"product":"TRAMADOL HYDROCHLORIDE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"LUPIN LTD","supplierCountry":"INDIA","foreign_port":"INDORE(EPZ\/SEZ)","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"10.75","actualQuantity":"10.75","unit":"KGS","unitRateFc":"54.4","totalValueFC":"590.2","currency":"USD","unitRateINR":"4700","date":"30-Apr-2025","totalValueINR":"50525","totalValueInUsd":"590.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29221990","bill_no":"9791468","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"INDORE(EPZ\/SEZ)","supplierAddress":"P.No.-M2 M2-A, Phase II INDORE SPECIAL ECONOMIC ZONE SDNF India","customerAddress":"159, C.S.T. ROAD,"}]
    05-Jan-2022
    30-Apr-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20281

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    DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20281

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    DOSAGE - TABLET;ORAL - 325MG;37.5MG

    USFDA APPLICATION NUMBER - 21123

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21692

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21692

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21692

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21745

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21745

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21745

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG

    USFDA APPLICATION NUMBER - 22370

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG

    USFDA APPLICATION NUMBER - 22370

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG

    USFDA APPLICATION NUMBER - 22370

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG

    USFDA APPLICATION NUMBER - 22370

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    ABOUT THIS PAGE

    Looking for 194602-08-9 / Tramadol Hydrochloride API manufacturers, exporters & distributors?

    Tramadol Hydrochloride manufacturers, exporters & distributors 1

    96

    PharmaCompass offers a list of Tramadol Hydrochloride 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 Tramadol Hydrochloride manufacturer or Tramadol Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Tramadol Hydrochloride

    Synonyms

    36282-47-0, Contramal, (+)-tramadol hydrochloride, Tradonal, 148229-78-1, Cis-tramadol hydrochloride

    Cas Number

    194602-08-9

    Unique Ingredient Identifier (UNII)

    9N7R477WCK

    About Tramadol Hydrochloride

    A narcotic analgesic proposed for severe pain. It may be habituating.

    Tridol Manufacturers

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

    Tridol Suppliers

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

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

    Tridol USDMF

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

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

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

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

    Tridol KDMF

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

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

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

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

    Tridol CEP

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

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

    Tridol WC

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

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

    Tridol 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 Tridol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tridol GMP

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

    Tridol CoA

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

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

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