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

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 14 EU WC, 36 KDMF, 24 NDC API, 25 Listed Suppliers, $ API Reference Price

58 API Suppliers
27 USDMF
24 CEP/COS
17 JDMF
14 EU WC
36 KDMF
24 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

143 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 13 Canada, 14 South Africa, 23 Listed Dossiers

143 FDF Dossiers
25 FDA Orange Book
68 Europe
13 Canada
14 South Africa
23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET

drugProductComposition
TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 1%
SOLUTION;TOPICAL - 1%
GRANULE;ORAL - EQ 125MG BASE/PACKET
GRANULE;ORAL - EQ 187.5MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 3 Seqens, 2 DKSH, 3 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 27 Controlled & Modified Release, 24 Disintegrants & Superdisintegrants, 24 Fillers, Diluents & Binders, 23 Topical, 21 Thickeners and Stabilizers, 18 Direct Compression, 17 Solubilizers, 15 Lubricants & Glidants, 15 Granulation, 11 Emulsifying Agents, 8 Co-Processed Excipients, 7 Parenteral, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Coloring Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
2 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 34 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
34 Finished Drug Prices

MARKET PLACE

17 APIs

marketPlace
17 APIs

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 2 Others

otherSolutions
2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 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)

$ 149

MARKET PLACE

API

FDF

7INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

143

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS 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)

10,097,312

Annual Reports (USD Million)

Finished Drug Prices

177 RELATED EXCIPIENT COMPANIES

292EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Terbinafine hcl, 78628-80-5, Lamisil at, (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride, Bramazil, Bramizil

Molecular Formula

C₂₁H₂₆ClN

Molecular Weight

327.9 g/mol

InChI Key

BWMISRWJRUSYEX-SZKNIZGXSA-N

FDA UNII

012C11ZU6G

A naphthalene derivative that inhibits fungal SQUALENE EPOXIDASE and is used to treat DERMATOMYCOSES of the skin and nails.

1 2D Structure

Terbinafine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C21H25N.ClH/c1-21(2,3)15-8-5-9-16-22(4)17-19-13-10-12-18-11-6-7-14-20(18)19;/h5-7,9-14H,16-17H2,1-4H3;1H/b9-5+;

2.1.3 InChI Key

BWMISRWJRUSYEX-SZKNIZGXSA-N

2.1.4 Canonical SMILES

CC(C)(C)C#CC=CCN(C)CC1=CC=CC2=CC=CC=C21.Cl

2.1.5 Isomeric SMILES

CC(C)(C)C#C/C=C/CN(C)CC1=CC=CC2=CC=CC=C21.Cl

2.2 Other Identifiers

2.2.1 UNII

012C11ZU6G

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (e)-n-(6,6-dimethyl-2-heptenynyl)-n-methyl-1-naphthalenementhamin Hydrochloride

2. Da 5505

3. Lamisil

4. Sf 86 327

5. Sf 86-327

6. Sf 86327

7. Sf-86-327

8. Sf86327

9. Tdt 067

10. Tdt-067

11. Tdt067

12. Terbinafine

13. Terbinafine, (z)-

14. Terbinafine, (z)-isomer

2.3.2 Depositor-Supplied Synonyms

1. Terbinafine Hcl

2. 78628-80-5

3. Lamisil At

4. (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride

5. Bramazil

6. Bramizil

7. Muzonal

8. Terbina

9. Terbine

10. Terbinafina

11. Terbinafinum

12. Zabel

13. Nsc-759113

14. Cpd000469152

15. Terbinafine (as Hydrochloride)

16. Chebi:77614

17. 012c11zu6g

18. (e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalenemethylamine Hydrochloride

19. Trans-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthylmethylamine Hydrochloride

20. 78628-80-5 (hcl)

21. Lamisil Krem

22. Trans-n-(6,6-dimethyl-2-hepten-4-ylyl)-n-methyl-1-naphthylmethylamine Hydrochloride

23. Terbinafinum [latin]

24. Terbinafina [spanish]

25. Athletes Foot

26. Mycova

27. (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine;hydrochloride

28. [(2e)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)(naphthalen-1-ylmethyl)amine Hydrochloride

29. N-[(2e)-6,6-dimethyl-2-hepten-4-yn-1-yl]-n-methyl-1-naphthalenemethanamine Hydrochloride

30. Sf 86-327 Hydrochloride

31. Smr000469152

32. N,6,6-trimethyl-n-(1-naphthylmethyl)hept-2-en-4-yn-1-amine Hydrochloride

33. Drg-0286

34. Terbinafine (hydrochloride)

35. Terbisil

36. Afogan

37. Terbifoam

38. Innonyx

39. Unii-012c11zu6g

40. Lamisil (tn)

41. Terbinafine Hydrochloride [usp:jan]

42. Mfcd00145430

43. Terbinafine,hydrochloride

44. Ec 616-640-4

45. Terbinafine Monohydrochloride

46. Schembl36793

47. Schembl36795

48. Mls001066620

49. Mls001304037

50. Mls001401424

51. Terbinafine Hydrochloride,(s)

52. Chembl1200832

53. Dtxsid90229223

54. Htu-520

55. Pharmakon1600-01505392

56. Terbinafine Hydrochloride, >=98%

57. Terbinafine Hydrochloride (lamisil)

58. Ac-761

59. Nsc759113

60. S2557

61. Terbinafine Hydrochloride [mi]

62. Akos015844100

63. Akos025149216

64. Terbinafine Hydrochloride (jp17/usp)

65. Bcp9000834

66. Ccg-101026

67. Cs-1123

68. Ks-1289

69. Nc00276

70. Nsc 759113

71. Terbinafine Hydrochloride [jan]

72. Terbinafine Hydrochloride [mart.]

73. Terbinafine Hydrochloride [vandf]

74. 1-naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-, (e)-, Monohydrochloride

75. 1-naphthalenemethanamine, N-[(2e)-6,6-dimethyl-2-hepten-4-yn-1-yl]-n-methyl-, Hydrochloride (1:1)

76. Bt164461

77. Hy-17395

78. Ls-14899

79. Sf-86327

80. Terbinafine Hydrochloride [usp-rs]

81. Terbinafine Hydrochloride [who-dd]

82. Nm-100060

83. B2047

84. D2049

85. Sw197656-2

86. D02219

87. Terbinafine Hydrochloride [ep Monograph]

88. Terbinafine Hydrochloride [orange Book]

89. Terbinafine Hydrochloride [usp Monograph]

90. 628t805

91. A839463

92. Q-201790

93. Q27147212

94. Terbinafine Hydrochloride, Antibiotic For Culture Media Use Only

95. Terbinafine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

96. (2e)-n,6,6-trimethyl-n-(1-naphthylmethyl)hept-2-en-4-yn-1-amine Hydrochloride

97. (2e)-n,6,6-trimethyl-n-(1-naphthylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (1:1)

98. (2e)-n,6,6-trimethyl-n-(1-naphthylmethyl)hept-2-en-4-yn-1-aminium Chloride

99. (2e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride

100. (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-aminehydrochloride

101. (e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalenemethanamine Hydrochloride

102. (e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthylmethylamine Hydrochloride

103. [(e)-6,6-dimethylhept-2-en-4-ynyl]-methyl-(naphthalen-1-ylmethyl)azanium;chloride

104. Terbinafine For System Suitability, European Pharmacopoeia (ep) Reference Standard

105. Terbinafine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

106. Terbinafine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

107. (e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalenemethylamine, Hydrochloride

108. 1-naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-, (e)-, Hydrochloride

2.4 Create Date

2005-10-11

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₆ClN
Molecular Weight	327.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	5
Exact Mass	327.1753775 g/mol
Monoisotopic Mass	327.1753775 g/mol
Topological Polar Surface Area	3.2 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	428
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Lamisil
Drug Label	Lamisil Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26...
Active Ingredient	Terbinafine hydrochloride
Dosage Form	Tablet; Cream; Granule
Route	Oral; Topical
Strength	eq 187.5mg base/packet; 1%; eq 250mg base; eq 125mg base/packet
Market Status	Over the Counter; Prescription
Company	Novartis

2 of 6
Drug Name	Lamisil at
Active Ingredient	Terbinafine hydrochloride; Terbinafine
Dosage Form	Spray; Gel; Solution
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Novartis

3 of 6
Drug Name	Terbinafine hydrochloride
PubMed Health	Terbinafine
Drug Classes	Antifungal
Drug Label	Terbinafine hydrochloride tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empiri...
Active Ingredient	Terbinafine hydrochloride
Dosage Form	Tablet; Cream
Route	oral; Oral; Topical
Strength	1%; eq 250mg base
Market Status	Tentative Approval; Over the Counter; Prescription
Company	Wockhardt; Harris Pharm; Breckenridge Pharm; Teva; Apotex; Aurobindo Pharma; Taro; Andrx Pharm; Invagen Pharms; Cipla; Glenmark Generics; Dr Reddys Labs; Orchid Hlthcare; Mylan

4 of 6
Drug Name	Lamisil
Drug Label	Lamisil Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26...
Active Ingredient	Terbinafine hydrochloride
Dosage Form	Tablet; Cream; Granule
Route	Oral; Topical
Strength	eq 187.5mg base/packet; 1%; eq 250mg base; eq 125mg base/packet
Market Status	Over the Counter; Prescription
Company	Novartis

5 of 6
Drug Name	Lamisil at
Active Ingredient	Terbinafine hydrochloride; Terbinafine
Dosage Form	Spray; Gel; Solution
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Novartis

6 of 6
Drug Name	Terbinafine hydrochloride
PubMed Health	Terbinafine
Drug Classes	Antifungal
Drug Label	Terbinafine hydrochloride tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empiri...
Active Ingredient	Terbinafine hydrochloride
Dosage Form	Tablet; Cream
Route	oral; Oral; Topical
Strength	1%; eq 250mg base
Market Status	Tentative Approval; Over the Counter; Prescription
Company	Wockhardt; Harris Pharm; Breckenridge Pharm; Teva; Apotex; Aurobindo Pharma; Taro; Andrx Pharm; Invagen Pharms; Cipla; Glenmark Generics; Dr Reddys Labs; Orchid Hlthcare; Mylan

4.2 Drug Indication

Treatment of onychomycosis

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Allylamine [CS]; Allylamine Antifungal [EPC]

API SUPPLIERS

01

LGM Pharma

U.S.A

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

Pharma, Lab & Chemical Expo

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

02

Metrochem API Private Limited

India

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

Pharma, Lab & Chemical Expo

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

03

Dr. Reddy's Laboratories

India

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

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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04

Jai Radhe Sales

India

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Not Confirmed

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

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05

Shandong Chenghui Shuangda Pharmac...

China

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CPhI China

Attending

China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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China

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Shandong Chenghui Shuangda Pharmaceutical

06

HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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AUDIT

07

Tagoor Laboratories

India

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

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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India

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08

TAPI Technology & API Services

Israel

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

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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09

Gedeon Richter

Hungary

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Pharma, Lab & Chemical Expo

Not Confirmed

10

UQUIFA

Spain

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Pharma, Lab & Chemical Expo

Not Confirmed

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USDMF

01

Dr Reddys Laboratories Ltd

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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TERBINAFINE HYDROCHLORIDE USP

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15887

Submission : 2002-03-06

Status : Active

Type : II

02

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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TERBINAFINE HYDROCHLORIDE

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18758

Submission : 2005-09-12

Status : Inactive

Type : II

Product Web Link

Corporate PDF

03

Amino Chemicals Ltd

Malta

Duphat

Not Confirmed

04

Cipla Ltd

India

Duphat

Not Confirmed

05

Gedeon Richter Plc

Duphat

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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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Drugs in Development

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INTERMEDIATES SUPPLIERS

01

Inabata France S.A.S

France

Pharma, Lab & Chemical Expo

Not Confirmed

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

1-Chloromethylnaphthalene

CAS Number : 86-52-2

End Use API : Terbinafine Hydrochloride

02

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

N-Methyl-1-naphthalene methylamine (Base)

CAS Number : 14489-75-9

End Use API : Terbinafine Hydrochloride

03

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

N-Methyl-1-naphthalene methylamine HCl

CAS Number : 65473-13-4

End Use API : Terbinafine Hydrochloride

04

Saptagir Laboratories

India

Pharma, Lab & Chemical Expo

Not Confirmed

05

Shandong Boyuan Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

06

Shandong Boyuan Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

07

Shandong Boyuan Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

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DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20539

DOSAGE - CREAM;TOPICAL - 1%

USFDA APPLICATION NUMBER - 20980

DOSAGE - SOLUTION;TOPICAL - 1%

USFDA APPLICATION NUMBER - 21124

DOSAGE - GRANULE;ORAL - EQ 125MG BASE/PACKET

USFDA APPLICATION NUMBER - 22071

DOSAGE - GRANULE;ORAL - EQ 187.5MG BASE/PACKE...DOSAGE - GRANULE;ORAL - EQ 187.5MG BASE/PACKET

USFDA APPLICATION NUMBER - 22071

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ABOUT THIS PAGE

Terbinafine Hydrochloride Manufacturers

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

Terbinafine Hydrochloride Suppliers

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

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

Terbinafine Hydrochloride USDMF

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

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

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

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

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

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

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

Terbinafine Hydrochloride CEP

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

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

Terbinafine Hydrochloride WC

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

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

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

Finished drug products

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

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

Terbinafine Hydrochloride GMP

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

Terbinafine Hydrochloride CoA

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

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

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

Find Terbinafine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers

27 USDMF

24 CEP/COS

17 JDMF

14 EU WC

36 KDMF

24 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

143 FDF Dossiers

25 FDA Orange Book

68 Europe

13 Canada

14 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 1%

SOLUTION;TOPICAL - 1%

GRANULE;ORAL - EQ 125MG BASE/PACKET

GRANULE;ORAL - EQ 187.5MG BASE/PACKET

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EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives

27 Controlled & Modified Release

24 Disintegrants & Superdisintegrants

24 Fillers, Diluents & Binders

23 Topical

21 Thickeners and Stabilizers

18 Direct Compression

17 Solubilizers

15 Lubricants & Glidants

15 Granulation

11 Emulsifying Agents

TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons