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    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
    Terbinafine Hydrochloride
    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 Weight 327.9 g/mol
    Molecular Formula C21H26ClN
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count5
    Exact Mass327.1753775 g/mol
    Monoisotopic Mass327.1753775 g/mol
    Topological Polar Surface Area3.2 Ų
    Heavy Atom Count23
    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 Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameLamisil
    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 6  
    Drug NameLamisil at
    Active IngredientTerbinafine hydrochloride; Terbinafine
    Dosage FormSpray; Gel; Solution
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyNovartis

    3 of 6  
    Drug NameTerbinafine hydrochloride
    PubMed HealthTerbinafine
    Drug ClassesAntifungal
    Drug LabelTerbinafine 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 IngredientTerbinafine hydrochloride
    Dosage FormTablet; Cream
    Routeoral; Oral; Topical
    Strength1%; eq 250mg base
    Market StatusTentative Approval; Over the Counter; Prescription
    CompanyWockhardt; 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 NameLamisil
    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

    5 of 6  
    Drug NameLamisil at
    Active IngredientTerbinafine hydrochloride; Terbinafine
    Dosage FormSpray; Gel; Solution
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyNovartis

    6 of 6  
    Drug NameTerbinafine hydrochloride
    PubMed HealthTerbinafine
    Drug ClassesAntifungal
    Drug LabelTerbinafine 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 IngredientTerbinafine hydrochloride
    Dosage FormTablet; Cream
    Routeoral; Oral; Topical
    Strength1%; eq 250mg base
    Market StatusTentative Approval; Over the Counter; Prescription
    CompanyWockhardt; 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]

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LTD","customerCountry":"INDIA","quantity":"1055.02","actualQuantity":"1055.02","unit":"KGS","unitRateFc":"146","totalValueFC":"159130","currency":"USD","unitRateINR":"12457.2","date":"20-Feb-2023","totalValueINR":"13142550.84","totalValueInUsd":"159130","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"4726277","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678041000,"product":"TERBINAFINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"SHANDONG ANHONG PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"IND SWIFT LTD","customerCountry":"INDIA","quantity":"344.98","actualQuantity":"344.98","unit":"KGS","unitRateFc":"146","totalValueFC":"52155","currency":"USD","unitRateINR":"12434.8","date":"06-Mar-2023","totalValueINR":"4289764.2","totalValueInUsd":"52155","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"4918072","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681842600,"product":"TERBINAFINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"SHANDONG ANHONG PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"IND SWIFT LTD","customerCountry":"INDIA","quantity":"358.80","actualQuantity":"358.8","unit":"KGS","unitRateFc":"146","totalValueFC":"54016.8","currency":"USD","unitRateINR":"12338","date":"19-Apr-2023","totalValueINR":"4426882.29","totalValueInUsd":"54016.8","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"5581765","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"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 CO","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GRACURE PHARMACEUTICALS LTD","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":"Q2","strtotime":1718217000,"product":"TERBINAFINE HCL (RETURNED CARGO DUE TO ORDER CANCEL VIDE SBNO.4439311 DT.06\/10\/2023)","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"PHARMACIN BV","supplierCountry":"INDIA","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"APITORIA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"152","totalValueFC":"30698.8","currency":"USD","unitRateINR":"12813.6","date":"13-Jun-2024","totalValueINR":"2562720","totalValueInUsd":"30698.8","indian_port":"Hyderabad Air","hs_no":"29211190","bill_no":"3973677","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"MOLENVLIET 103, 3335 LH ZHIJNDRECHT, THE NETHERLANDS NETHERLANDS, , Netherlands Netherlands","customerAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE","address":"OFFICE NO. 606,607,608, Shapath-5,","city":"AHMEDABAD","supplier":"SHANDONG ANHONG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"JAMP INDIA PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"200","totalValueFC":"2015.8","currency":"USD","unitRateINR":"17460","date":"24-Mar-2025","totalValueINR":"174600","totalValueInUsd":"2015.8","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9072332","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.29 HUAYUAN STREET LINYI COUNTY, DEZHOU, SHANDONG, CHINA SDNF China","customerAddress":"OFFICE NO. 606,607,608, Shapath-5,"}]
    03-Jan-2022
    30-May-2025
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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

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    DOSAGE - CREAM;TOPICAL - 1%

    USFDA APPLICATION NUMBER - 20980

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    DOSAGE - SOLUTION;TOPICAL - 1%

    USFDA APPLICATION NUMBER - 21124

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

    USFDA APPLICATION NUMBER - 22071

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    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

    Looking for 78628-80-5 / Terbinafine Hydrochloride API manufacturers, exporters & distributors?

    Terbinafine Hydrochloride manufacturers, exporters & distributors 1

    98

    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.

    API | Excipient name

    Terbinafine Hydrochloride

    Synonyms

    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

    Cas Number

    78628-80-5

    Unique Ingredient Identifier (UNII)

    012C11ZU6G

    About Terbinafine Hydrochloride

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

    012C11ZU6G Manufacturers

    A 012C11ZU6G manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 012C11ZU6G, including repackagers and relabelers. The FDA regulates 012C11ZU6G manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 012C11ZU6G 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 012C11ZU6G manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    012C11ZU6G Suppliers

    A 012C11ZU6G supplier is an individual or a company that provides 012C11ZU6G active pharmaceutical ingredient (API) or 012C11ZU6G finished formulations upon request. The 012C11ZU6G suppliers may include 012C11ZU6G API manufacturers, exporters, distributors and traders.

    click here to find a list of 012C11ZU6G suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    012C11ZU6G USDMF

    A 012C11ZU6G DMF (Drug Master File) is a document detailing the whole manufacturing process of 012C11ZU6G active pharmaceutical ingredient (API) in detail. Different forms of 012C11ZU6G DMFs exist exist since differing nations have different regulations, such as 012C11ZU6G USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A 012C11ZU6G DMF submitted to regulatory agencies in the US is known as a USDMF. 012C11ZU6G USDMF includes data on 012C11ZU6G's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 012C11ZU6G USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of 012C11ZU6G suppliers with USDMF on PharmaCompass.

    012C11ZU6G 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 012C11ZU6G Drug Master File in Japan (012C11ZU6G JDMF) empowers 012C11ZU6G 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 012C11ZU6G JDMF during the approval evaluation for pharmaceutical products. At the time of 012C11ZU6G 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 012C11ZU6G suppliers with JDMF on PharmaCompass.

    012C11ZU6G KDMF

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

    Pharmaceutical companies submit a 012C11ZU6G Drug Master File in Korea (012C11ZU6G KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 012C11ZU6G. The MFDS reviews the 012C11ZU6G KDMF as part of the drug registration process and uses the information provided in the 012C11ZU6G KDMF to evaluate the safety and efficacy of the drug.

    After submitting a 012C11ZU6G 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 012C11ZU6G API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of 012C11ZU6G suppliers with KDMF on PharmaCompass.

    012C11ZU6G CEP

    A 012C11ZU6G CEP of the European Pharmacopoeia monograph is often referred to as a 012C11ZU6G Certificate of Suitability (COS). The purpose of a 012C11ZU6G CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 012C11ZU6G EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 012C11ZU6G to their clients by showing that a 012C11ZU6G CEP has been issued for it. The manufacturer submits a 012C11ZU6G CEP (COS) as part of the market authorization procedure, and it takes on the role of a 012C11ZU6G CEP holder for the record. Additionally, the data presented in the 012C11ZU6G CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 012C11ZU6G DMF.

    A 012C11ZU6G CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 012C11ZU6G 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 012C11ZU6G suppliers with CEP (COS) on PharmaCompass.

    012C11ZU6G WC

    A 012C11ZU6G written confirmation (012C11ZU6G WC) is an official document issued by a regulatory agency to a 012C11ZU6G manufacturer, verifying that the manufacturing facility of a 012C11ZU6G active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 012C11ZU6G APIs or 012C11ZU6G finished pharmaceutical products to another nation, regulatory agencies frequently require a 012C11ZU6G WC (written confirmation) as part of the regulatory process.

    click here to find a list of 012C11ZU6G suppliers with Written Confirmation (WC) on PharmaCompass.

    012C11ZU6G 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 012C11ZU6G as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for 012C11ZU6G 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 012C11ZU6G 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 012C11ZU6G and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 012C11ZU6G NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of 012C11ZU6G suppliers with NDC on PharmaCompass.

    012C11ZU6G GMP

    012C11ZU6G 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 012C11ZU6G 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 012C11ZU6G GMP manufacturer or 012C11ZU6G GMP API supplier for your needs.

    012C11ZU6G CoA

    A 012C11ZU6G CoA (Certificate of Analysis) is a formal document that attests to 012C11ZU6G's compliance with 012C11ZU6G specifications and serves as a tool for batch-level quality control.

    012C11ZU6G CoA mostly includes findings from lab analyses of a specific batch. For each 012C11ZU6G 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.

    012C11ZU6G may be tested according to a variety of international standards, such as European Pharmacopoeia (012C11ZU6G EP), 012C11ZU6G JP (Japanese Pharmacopeia) and the US Pharmacopoeia (012C11ZU6G 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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