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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]

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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

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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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