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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
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
| Molecular Weight | 327.9 g/mol |
|---|---|
| Molecular Formula | C21H26ClN |
| 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 Ų |
| 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 |
| 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 |
Treatment of onychomycosis
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.)
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15887
Submission : 2002-03-06
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-024
Start Marketing Date : 2002-03-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2014-07-07
Registration Number : 20050831-49-A-99-09(5)
Manufacturer Name : Dr.Reddy''s Laboratories Ltd
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
Jai Radhe Sales is your partner for all your sourcing needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Date of Issue : 2024-12-09
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
Address of the Firm :
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18758
Submission : 2005-09-12
Status : Inactive
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 20050831-49-A-99-09(1)
Manufacturer Name : Dr.Reddy\'s Laboratories Ltd.
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-49-A-99-09
Manufacturer Name : Dr.Reddy\'s Laboratories Ltd.
Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, India
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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
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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
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PharmaCompass offers a list of Terbinafine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Terbinafine Hydrochloride manufacturer or Terbinafine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Terbinafine Hydrochloride manufacturer or Terbinafine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Terbinafine Hydrochloride API Price utilized in the formulation of products. Terbinafine Hydrochloride API Price is not always fixed or binding as the Terbinafine Hydrochloride Price is obtained through a variety of data sources. The Terbinafine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Terbinafinum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbinafinum, including repackagers and relabelers. The FDA regulates Terbinafinum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbinafinum 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 Terbinafinum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terbinafinum supplier is an individual or a company that provides Terbinafinum active pharmaceutical ingredient (API) or Terbinafinum finished formulations upon request. The Terbinafinum suppliers may include Terbinafinum API manufacturers, exporters, distributors and traders.
click here to find a list of Terbinafinum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terbinafinum DMF (Drug Master File) is a document detailing the whole manufacturing process of Terbinafinum active pharmaceutical ingredient (API) in detail. Different forms of Terbinafinum DMFs exist exist since differing nations have different regulations, such as Terbinafinum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terbinafinum DMF submitted to regulatory agencies in the US is known as a USDMF. Terbinafinum USDMF includes data on Terbinafinum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terbinafinum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terbinafinum suppliers with USDMF on PharmaCompass.
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 Terbinafinum Drug Master File in Japan (Terbinafinum JDMF) empowers Terbinafinum 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 Terbinafinum JDMF during the approval evaluation for pharmaceutical products. At the time of Terbinafinum 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 Terbinafinum suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Terbinafinum Drug Master File in Korea (Terbinafinum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Terbinafinum. The MFDS reviews the Terbinafinum KDMF as part of the drug registration process and uses the information provided in the Terbinafinum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Terbinafinum 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 Terbinafinum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Terbinafinum suppliers with KDMF on PharmaCompass.
A Terbinafinum CEP of the European Pharmacopoeia monograph is often referred to as a Terbinafinum Certificate of Suitability (COS). The purpose of a Terbinafinum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Terbinafinum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Terbinafinum to their clients by showing that a Terbinafinum CEP has been issued for it. The manufacturer submits a Terbinafinum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Terbinafinum CEP holder for the record. Additionally, the data presented in the Terbinafinum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Terbinafinum DMF.
A Terbinafinum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Terbinafinum 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 Terbinafinum suppliers with CEP (COS) on PharmaCompass.
A Terbinafinum written confirmation (Terbinafinum WC) is an official document issued by a regulatory agency to a Terbinafinum manufacturer, verifying that the manufacturing facility of a Terbinafinum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Terbinafinum APIs or Terbinafinum finished pharmaceutical products to another nation, regulatory agencies frequently require a Terbinafinum WC (written confirmation) as part of the regulatory process.
click here to find a list of Terbinafinum suppliers with Written Confirmation (WC) on PharmaCompass.
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 Terbinafinum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Terbinafinum API and other APIs are published in this directory by the FDA.
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 Terbinafinum 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.
The NDC directory also contains data on finished compounded human drug products that contain Terbinafinum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Terbinafinum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Terbinafinum suppliers with NDC on PharmaCompass.
Terbinafinum 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 Terbinafinum 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 Terbinafinum GMP manufacturer or Terbinafinum GMP API supplier for your needs.
A Terbinafinum CoA (Certificate of Analysis) is a formal document that attests to Terbinafinum's compliance with Terbinafinum specifications and serves as a tool for batch-level quality control.
Terbinafinum CoA mostly includes findings from lab analyses of a specific batch. For each Terbinafinum 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.
Terbinafinum may be tested according to a variety of international standards, such as European Pharmacopoeia (Terbinafinum EP), Terbinafinum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Terbinafinum USP).
