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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

84 API Suppliers, 37 USDMF, 27 CEP/COS, 7 JDMF, 18 EU WC, 68 KDMF, 21 NDC API, 44 Listed Suppliers, $ API Reference Price

84 API Suppliers
37 USDMF
27 CEP/COS
7 JDMF
18 EU WC
68 KDMF
21 NDC API
44 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

778 FDF Dossiers, 80 FDA Orange Book, 417 Europe, 34 Canada, 57 Australia, 42 South Africa, 148 Listed Dossiers

778 FDF Dossiers
80 FDA Orange Book
417 Europe
34 Canada
57 Australia
42 South Africa
148 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

drugProductComposition
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 325MG;37.5MG
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 150MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Evonik, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 10 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 34 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

relatedExcipients
1 Minakem
6 Evonik
2 Rochem International Inc
17 SPI Pharma
2 Seqens
10 DKSH
1 Pharm-RX Chemical
7 Faran Shimi Pharmaceutical
11 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
14 Gangwal Healthcare
10 Nanjing Well Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
5 Actylis
1 Aeon Procare
2 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
34 BASF
3 Clariant
11 Corel Pharma Chem
7 DFE Pharma
2 Finar
12 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
39 Kerry
4 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
4 Novo Excipients
5 Pharmatrans-Sanaq
7 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
22 Roquette
16 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
3 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

101 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 49 Direct Compression, 45 Disintegrants & Superdisintegrants, 40 Controlled & Modified Release, 39 Thickeners and Stabilizers, 34 Solubilizers, 33 Granulation, 30 Lubricants & Glidants, 27 Topical, 23 Parenteral, 23 Film Formers & Plasticizers, 23 Co-Processed Excipients, 19 Taste Masking, 19 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 7 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 387 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
387 Finished Drug Prices

MARKET PLACE

60 APIs, 27 FDF Dossiers

marketPlace
60 APIs
27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 1 US Exclusivities, 12 Health Canada Patents

patents
9 US Patents
1 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 8 Others

otherSolutions
3 EDQM
1 USP
8 Others

ANALYTICAL

2 BioAnalytical Methods

otherMethods
2 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 69

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

778

FDF Dossiers

FDA Orange Book

417

Europe

Canada

Australia

South Africa

148

Listed Dossiers

15DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

94,225,286

Annual Reports (USD Million)

Finished Drug Prices

353 RELATED EXCIPIENT COMPANIES

619EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

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

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 Formula	C₁₆H₂₆ClNO₂
Molecular Weight	299.83 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	299.1652068 g/mol
Monoisotopic Mass	299.1652068 g/mol
Topological Polar Surface Area	32.7 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	282
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Conzip
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	ConZip (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 Ingredient	Tramadol hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	300mg; 200mg; 100mg; 150mg
Market Status	Prescription
Company	Cipher Pharms

2 of 6
Drug Name	Tramadol hydrochloride
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	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 molecu...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	200mg; 300mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen 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 Name	Ultram er
Drug Label	ULTRAMER (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 Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	200mg; 300mg; 100mg
Market Status	Prescription
Company	Valeant Intl

4 of 6
Drug Name	Conzip
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	ConZip (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 Ingredient	Tramadol hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	300mg; 200mg; 100mg; 150mg
Market Status	Prescription
Company	Cipher Pharms

5 of 6
Drug Name	Tramadol hydrochloride
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	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 molecu...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	200mg; 300mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen 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 Name	Ultram er
Drug Label	ULTRAMER (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 Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	200mg; 300mg; 100mg
Market Status	Prescription
Company	Valeant 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 SUPPLIERS

01

Supriya Lifescience

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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India

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USDMF

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CEP/COS JDMF EU-WC

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VMF ASMF

AUDIT

02

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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U.S.A

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03

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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04

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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India

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05

Inabata France S.A.S

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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France

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06

Seqens

France

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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07

Suanfarma

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DCAT Week

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Suanfarma, at the Core of a Better Life.

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Spain

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08

Temad Co

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

MAGHREB PHARMA

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Temad- We think of world-class quality.

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Iran

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09

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

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India

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10

Faran Shimi Pharmaceutical

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Iran

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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USDMF

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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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

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

DOSAGE - TABLET;ORAL - 325MG;37.5MG

USFDA APPLICATION NUMBER - 21123

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

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

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

USFDA APPLICATION NUMBER - 21745

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

USFDA APPLICATION NUMBER - 22370

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

USFDA APPLICATION NUMBER - 22370

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

USFDA APPLICATION NUMBER - 22370

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

USFDA APPLICATION NUMBER - 22370

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ABOUT THIS PAGE

Tramadol Hydrochloride Manufacturers

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

Tramadol Hydrochloride Suppliers

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

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

Tramadol Hydrochloride USDMF

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

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

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

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

Tramadol Hydrochloride KDMF

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

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

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

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

Tramadol Hydrochloride CEP

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

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

Tramadol Hydrochloride WC

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

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

Tramadol Hydrochloride 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 Tramadol Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tramadol Hydrochloride GMP

Tramadol Hydrochloride 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 Tramadol Hydrochloride 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 Tramadol Hydrochloride GMP manufacturer or Tramadol Hydrochloride GMP API supplier for your needs.

Tramadol Hydrochloride CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

84 API Suppliers

37 USDMF

27 CEP/COS

7 JDMF

18 EU WC

68 KDMF

21 NDC API

44 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

778 FDF Dossiers

80 FDA Orange Book

417 Europe

34 Canada

57 Australia

42 South Africa

148 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

TABLET;ORAL - 325MG;37.5MG

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

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

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

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

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

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

CAPSULE, EXTENDED RELEASE;ORAL - 100MG

CAPSULE, EXTENDED RELEASE;ORAL - 150MG

CAPSULE, EXTENDED RELEASE;ORAL - 200MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

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

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

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

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

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

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

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

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