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Chemistry

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Also known as: 91161-71-6, Lamisil, Lamasil, (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine, Sf-86-327, Lamisil at
Molecular Formula
C21H25N
Molecular Weight
291.4  g/mol
InChI Key
DOMXUEMWDBAQBQ-WEVVVXLNSA-N
FDA UNII
G7RIW8S0XP

Terbinafine
A naphthalene derivative that inhibits fungal SQUALENE EPOXIDASE and is used to treat DERMATOMYCOSES of the skin and nails.
Terbinafine is an Allylamine Antifungal.
1 2D Structure

Terbinafine

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
2.1.2 InChI
InChI=1S/C21H25N/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/b9-5+
2.1.3 InChI Key
DOMXUEMWDBAQBQ-WEVVVXLNSA-N
2.1.4 Canonical SMILES
CC(C)(C)C#CC=CCN(C)CC1=CC=CC2=CC=CC=C21
2.1.5 Isomeric SMILES
CC(C)(C)C#C/C=C/CN(C)CC1=CC=CC2=CC=CC=C21
2.2 Other Identifiers
2.2.1 UNII
G7RIW8S0XP
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 Hydrochloride

13. Terbinafine, (z)-

14. Terbinafine, (z)-isomer

2.3.2 Depositor-Supplied Synonyms

1. 91161-71-6

2. Lamisil

3. Lamasil

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

5. Sf-86-327

6. Lamisil At

7. Sf 86-327

8. Terbinafin

9. Terbinex

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

11. Terbinafina

12. (e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalene Methanamine

13. Terbinafine Free Base

14. Tdt-067

15. G7riw8s0xp

16. Chembl822

17. Chebi:9448

18. Lamisil Tablet

19. 91161-71-6 (free Base)

20. Terbinafinum

21. Zabel

22. 1-naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-, (e)-

23. Ncgc00159346-02

24. (2e)-n,6,6-trimethyl-n-(1-naphthylmethyl)hept-2-en-4-yn-1-amine

25. (2e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine

26. Dsstox_cid_3640

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

28. Dsstox_rid_77123

29. Dsstox_gsid_23640

30. Lamasil (tn)

31. Cas-91161-71-6

32. Unii-g7riw8s0xp

33. Terbinafine (usan/inn)

34. Brn 4256376

35. Corbinal

36. Terbinafine [usan:inn:ban]

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

38. Erbinafine Hydrochloride

39. Terbinafine [mi]

40. Terbinafine, Sf-86-327, Lamisil, Tbnf

41. Terbinafine [inn]

42. Terbinafine [usan]

43. Ec 618-706-8

44. Terbinafine [vandf]

45. Terbinafine [mart.]

46. Schembl36794

47. Schembl37843

48. Terbinafine [who-dd]

49. Mls006011885

50. Bidd:gt0825

51. Dtxsid2023640

52. Terbinafine (lamisil, Terbinex)

53. Terbinafine [green Book]

54. Chebi:94705

55. Terbinafine [orange Book]

56. Hms2089b20

57. Hms3715l08

58. Albb-027269

59. Bcp22896

60. Osurnia Component Terbinafine

61. Zinc1530981

62. Tox21_111591

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

64. Bbl010959

65. Bdbm50018518

66. Hy-17395a

67. Mfcd00242672

68. S1725

69. Stk802069

70. Akos001451917

71. Tox21_111591_1

72. Ac-8561

73. Ccg-221253

74. Cs-1944

75. Db00857

76. Gs-3099

77. Terbinafine Component Of Osurnia

78. (e)-n,6,6-trimethyl-n-(naphthalen-1

79. Ncgc00159346-03

80. Ncgc00159346-04

81. Ncgc00188975-01

82. Terbinafine [ema Epar Veterinary]

83. Sf86-327

84. Smr004703509

85. Sbi-0206829.p001

86. Sw197656-3

87. T3677

88. C08079

89. D02375

90. Ab00698510-07

91. Ab00698510-09

92. Ab00698510-10

93. Ab00698510-11

94. Ab00698510_12

95. Ab00698510_13

96. Ab00698510_14

97. 161t716

98. A843743

99. Q415259

100. Brd-k68132782-003-05-4

101. (6,6-dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine

102. N,6,6-trimethyl-n-(1-naphthylmethyl)-2-heptene-4-yne-1-amine

103. Sf 86-327; Sf-86-327; Sf86-327; Lamasil; Lamisil At

104. ((e)-6,6-dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine

105. 1n,6,6-trimethyl-1n-(1-naphthylmethyl)-(e)-2-hepten-4-yn-1-amine

106. (6,6-dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine(terbinafine)

107. (6,6-dimethylhept-2-en-4-yn-1-yl)methyl(1-naphthylmethyl)amine Hydrochloride

108. [(2e)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)[(naphthalen-1-yl)methyl]amine

109. [(e)-6,6-dimethyl-hept-2-en-4-ynyl]-methyl-(naphthalen-1-yl-methyl)-amine

110. 1-naphthalenemethanamine, N-[(2e)-6,6-dimethyl-2-hepten-4-yn-1-yl]-n-methyl-

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 291.4 g/mol
Molecular Formula C21H25N
XLogP35.6
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count1
Rotatable Bond Count5
Exact Mass291.198699802 g/mol
Monoisotopic Mass291.198699802 g/mol
Topological Polar Surface Area3.2 Ų
Heavy Atom Count22
Formal Charge0
Complexity428
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameLamisil
PubMed HealthTerbinafine
Drug ClassesAntifungal
Drug LabelLamisil 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 IngredientTerbinafine hydrochloride
Dosage FormTablet; Cream; Granule
RouteOral; Topical
Strengtheq 187.5mg base/packet; 1%; eq 250mg base; eq 125mg base/packet
Market StatusOver the Counter; Prescription
CompanyNovartis

2 of 4  
Drug NameLamisil at
Active IngredientTerbinafine hydrochloride; Terbinafine
Dosage FormSpray; Gel; Solution
RouteTopical
Strength1%
Market StatusOver the Counter
CompanyNovartis

3 of 4  
Drug NameLamisil
PubMed HealthTerbinafine
Drug ClassesAntifungal
Drug LabelLamisil 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 IngredientTerbinafine hydrochloride
Dosage FormTablet; Cream; Granule
RouteOral; Topical
Strengtheq 187.5mg base/packet; 1%; eq 250mg base; eq 125mg base/packet
Market StatusOver the Counter; Prescription
CompanyNovartis

4 of 4  
Drug NameLamisil at
Active IngredientTerbinafine hydrochloride; Terbinafine
Dosage FormSpray; Gel; Solution
RouteTopical
Strength1%
Market StatusOver the Counter
CompanyNovartis

4.2 Drug Indication

Terbinafine hydrochloride is indicated to treat fungal skin and nail infections caused by _Trichophyton_ species, _Microsporum canis_, _Epidermophyton floccosum_, and _Tinea_ species. Terbinafine hydrochloride also treats yeast infections of the skin caused by _Candida_ species and _Malassezia furfur_.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Terbinafine is an allylamine antifungal that inhibits squalene epoxidase (also known as squalene monooxygenase) to prevent the formation of ergosterol and cause an accumulation of squalene, weakening the cell wall of fungal cells. Terbinafine distributes into tissues and has a long terminal elimination half life, so the duration of action is long. Overdose with terbinafine is rare, even above the therapeutic dose, so the therapeutic index is wide. Patients taking oral terbinafine should have liver function tests performed prior to treatment to reduce the risk of liver injury.


5.2 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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
TERBINAFINE
5.3.2 FDA UNII
G7RIW8S0XP
5.3.3 Pharmacological Classes
Allylamine [CS]; Allylamine Antifungal [EPC]
5.4 ATC Code

D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AE - Other antifungals for topical use

D01AE15 - Terbinafine


D - Dermatologicals

D01 - Antifungals for dermatological use

D01B - Antifungals for systemic use

D01BA - Antifungals for systemic use

D01BA02 - Terbinafine


5.5 Absorption, Distribution and Excretion

Absorption

Oral terbinafine is >70% absorbed but only 40% bioavailable after first pass metabolism, reaching a Cmax of 1g/mL with a Tmax of 2 hours an an AUC of 4.56g\*h/mL. Over the course of a week, 1% topical terbinafine's Cmax increases from 949-1049ng/cm2 and the AUC increases from 9694-13,492ng/cm2/h.


Route of Elimination

Terbinafine is approximately 80% eliminated in urine, while the remainder is eliminated in feces. The unmetabolized parent drug is not present in urine.


Volume of Distribution

A single 250mg oral dose of terbinafine has a volume of distribution at steady state of 947.5L or 16.6L/kg.


Clearance

A single 250mg oral dose of terbinafine has a clearance of 76L/h or 1.11L/h/kg.


5.6 Metabolism/Metabolites

Terbinafine can be deaminated to 1-naphthaldehyde by CYP2C9, 2B6, 2C8, 1A2, 3A4, and 2C19. 1-naphthaldehyde is then oxidized to 1-naphthoic acid or reduced to 1-naphthalenemethanol. Terbinafine can also be hydroxylated by CYP1A2, 2C9, 2C8, 2B6, and 2C19 to hydroxyterbinafine. Hydroxyterbinafine is then oxidized to carboxyterbinafine or N-demethylated by CYP3A4, 2B6, 1A2, 2C9, 2C8, and 2C19 to desmethylhydroxyterbinafine. Terbinafine can be N-demethylated to desmethylterbinafine. Desmethylterbinafine is then dihydroxylated to a desmethyldihydrodiol or hydroxylated to desmethylhydroxyterbinafine. Finally, terbinafine can be dihydroxylated to a dihydrodiol which is then N-demethylated to a desmethyldihydrodiol.


Terbinafine has known human metabolites that include 1-Naphtaldehyde, Hydroxyterbinafine, and N-Desmethylterbinafine.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

Oral terbinafine has an effective half life of approximately 36 hours. However, the terminal half life ranges from 200-400 hours as it distributes into skin and adipose tissue. 1% topical terbinafine's half life increases over the first seven days from approximately 10-40 hours.


5.8 Mechanism of Action

Terbinafine inhibits the enzyme squalene monooxygenase (also called squalene epoxidase), preventing the conversion of squalene to 2,3-oxydosqualene, a step in the synthesis of ergosterol. This inhibition leads to decreased ergosterol, which would normally be incorporated into the cell wall, and accumulation of squalene. Generation of a large number of squalene containing vesicles in the cytoplasm may leach other lipids away from, and further weaken, the cell wall.


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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1325000","totalValueFC":"281.7","currency":"USD","unitRateINR":"115842150","date":"06-Mar-2023","totalValueINR":"23168.43","totalValueInUsd":"281.7","indian_port":"HYDERABAD AIR","hs_no":"29214990","bill_no":"4921488","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682965800,"product":"6 6 DIMETHYL 1 HEPTEN 4 YN 3 OL TERBINAFINE SIDE CHAIN","address":"FLAT NO. 302, BHANU ENCLAVE, BESID E,ESI HOSPITAL, ERRAGADDA.","city":"HYDERABAD","supplier":"ZHEJIANG HENGDIAN APELOA IMP EXP CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SYNERGENE ACTIVE INGREDIENTS PVT LTD","customerCountry":"INDIA","quantity":"1050.00","actualQuantity":"1050","unit":"KGS","unitRateFc":"56","totalValueFC":"59418.7","currency":"USD","unitRateINR":"4656.4","date":"02-May-2023","totalValueINR":"4889220","totalValueInUsd":"59418.7","indian_port":"MADRAS SEA","hs_no":"29032900","bill_no":"0","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"China","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"","customerAddress":"FLAT NO. 302, BHANU ENCLAVE, BESID E,ESI HOSPITAL, ERRAGADDA."},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693506600,"product":"TERBINAFINE HYDROCHLORIDE","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"AMINO CHEMICALS","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"800","totalValueFC":"80859.5","currency":"USD","unitRateINR":"67120","date":"01-Sep-2023","totalValueINR":"6712000","totalValueInUsd":"80859.5","indian_port":"Bombay Air","hs_no":"29214990","bill_no":"7626250","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"MRA050X, INDUSTRIAL ESTATE MARSA, MRS3000, MALTA.SDNF Malta","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700245800,"product":"TERBINAFINE HYDROCHLORIDE EP GRADE (FOR PHARMACEUTICAL USE)","address":"251-254,IIND FLOOR, DLF TOWER","city":"NEW DELHI","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GRACURE PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"200","totalValueFC":"1211.9","currency":"USD","unitRateINR":"16820","date":"18-Nov-2023","totalValueINR":"100920","totalValueInUsd":"1211.9","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8817210","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"LTD. NO. 29, HUAYUAN STREET LINYICOUNTY, DEZHOU, SHANDONG, CHINADEZHOU SHANDONG, CHINA SDNF","customerAddress":"251-254,IIND FLOOR, DLF TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700245800,"product":"TERBINAFINE HYDROCHLORIDE EP GRADE (FOR PHARMACEUTICAL USE)","address":"251-254,IIND FLOOR, DLF TOWER","city":"NEW DELHI","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GRACURE PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"200","totalValueFC":"2019.9","currency":"USD","unitRateINR":"16820","date":"18-Nov-2023","totalValueINR":"168200","totalValueInUsd":"2019.9","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8817210","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"LTD. NO. 29, HUAYUAN STREET LINYICOUNTY, DEZHOU, SHANDONG, CHINADEZHOU SHANDONG, CHINA SDNF","customerAddress":"251-254,IIND FLOOR, DLF TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"TERBINAFINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"128","totalValueFC":"3237.1","currency":"USD","unitRateINR":"10860.8","date":"17-Aug-2024","totalValueINR":"271520","totalValueInUsd":"3237.1","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"5101672","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.29 HUAYUAN STREET LINYI COUNTY DEZHOU SHANDONG CHINA, , CHINASDNF CHINA","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"TERBINAFINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"128","totalValueFC":"25896.5","currency":"USD","unitRateINR":"10860.8","date":"17-Aug-2024","totalValueINR":"2172160","totalValueInUsd":"25896.5","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"5101672","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.29 HUAYUAN STREET LINYI COUNTY DEZHOU SHANDONG CHINA, , CHINASDNF CHINA","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"TERBINAFINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"201.84","actualQuantity":"201.84","unit":"KGS","unitRateFc":"128","totalValueFC":"26081.8","currency":"USD","unitRateINR":"10828.8","date":"25-Sep-2024","totalValueINR":"2185684.99","totalValueInUsd":"26081.8","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"5784706","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.29 HUAYUAN STREET LINYI COUNTY D EZHOU SHANDONG CHINA, , CHINA SDNF CHINA","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"TERBINAFINE RELATED COMPOUND B (QTY: 1 X 25 MG, VALUE: USD 903)(FOC)SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.000025","unit":"KGS","unitRateFc":"36652800","totalValueFC":"928.8","currency":"USD","unitRateINR":"3218116400","date":"07-Mar-2025","totalValueINR":"80452.91","totalValueInUsd":"928.8","indian_port":"Hyderabad Air","hs_no":"29214990","bill_no":"8760298","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704, SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]
04-Jan-2021
26-Apr-2025
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ABOUT THIS PAGE

Looking for 91161-71-6 / Terbinafine API manufacturers, exporters & distributors?

Terbinafine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Terbinafine

Synonyms

91161-71-6, Lamisil, Lamasil, (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine, Sf-86-327, Lamisil at

Cas Number

91161-71-6

Unique Ingredient Identifier (UNII)

G7RIW8S0XP

About Terbinafine

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

Terbinafine Manufacturers

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

Terbinafine Suppliers

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

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

Terbinafine USDMF

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

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

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

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

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

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

Terbinafine WC

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

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

Terbinafine 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Terbinafine GMP

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

Terbinafine CoA

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

Terbinafine CoA mostly includes findings from lab analyses of a specific batch. For each Terbinafine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Terbinafine EP), Terbinafine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Terbinafine 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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