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    Chemistry

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    Also known as: 894-71-3, Nortriptyline hcl, Pamelor, Desmethylamitriptyline hydrochloride, Allegron, Acetexa
    Molecular Formula
    C19H22ClN
    Molecular Weight
    299.8  g/mol
    InChI Key
    SHAYBENGXDALFF-UHFFFAOYSA-N
    FDA UNII
    00FN6IH15D
    Nortriptyline
    A metabolite of AMITRIPTYLINE that is also used as an antidepressive agent. Nortriptyline is used in major depression, dysthymia, and atypical depressions.
    1 2D Structure

    Nortriptyline

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-methyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H21N.ClH/c1-20-14-6-11-19-17-9-4-2-7-15(17)12-13-16-8-3-5-10-18(16)19;/h2-5,7-11,20H,6,12-14H2,1H3;1H
    2.1.3 InChI Key
    SHAYBENGXDALFF-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CNCCC=C1C2=CC=CC=C2CCC3=CC=CC=C31.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    00FN6IH15D
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Allegron

    2. Apo Nortriptyline

    3. Apo-nortriptyline

    4. Aventyl

    5. Desitriptyline

    6. Desmethylamitriptylin

    7. Gen Nortriptyline

    8. Gen-nortriptyline

    9. Hydrochloride, Nortriptyline

    10. Norfenazin

    11. Nortrilen

    12. Nortriptyline

    13. Novo Nortriptyline

    14. Novo-nortriptyline

    15. Nu Nortriptyline

    16. Nu-nortriptyline

    17. Pamelor

    18. Paxtibi

    19. Pms Nortriptyline

    20. Pms-nortriptyline

    21. Ratio Nortriptyline

    22. Ratio-nortriptyline

    2.3.2 Depositor-Supplied Synonyms

    1. 894-71-3

    2. Nortriptyline Hcl

    3. Pamelor

    4. Desmethylamitriptyline Hydrochloride

    5. Allegron

    6. Acetexa

    7. Altilev

    8. Nortriptyline (hydrochloride)

    9. Nortrilen

    10. Aventyl Hydrochloride

    11. Sensival

    12. Vividyl

    13. Aventyl Allegron

    14. Ateben Hydrochloride

    15. Nortab Hydrochloride

    16. Psychostyl

    17. Nortriptylin Hydrochloride

    18. Lilly 38489

    19. Noramitriptyline Hydrochloride

    20. Nortriptyline Monohydrochloride

    21. Nsc-169453

    22. 3-(10,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n-methyl-1-propanamine Hydrochloride

    23. Mls000069673

    24. 00fn6ih15d

    25. N 7048

    26. Smr000058486

    27. Pamelor Hydrochloride

    28. 1-propanamine, 3-(10,11-dihydro-5h-dibenzo(a,d)cyclohepten-5-ylidene)-n-methyl-, Hydrochloride

    29. Nortriptylene Hydrochloride

    30. Norzepine

    31. 3-(10,11-dihydro-5h-dibenzo[a,d][7]annulen-5-ylidene)-n-methylpropan-1-amine Hydrochloride

    32. Wln: L C676 By&t&j Bu3m1 &gh

    33. Nsc78248

    34. Nortriptylinehydrochloride

    35. Nsc169453

    36. Sr-01000000223

    37. Cas-894-71-3

    38. Mfcd00058024

    39. Unii-00fn6ih15d

    40. 5-[3-(methylamino)propylidene]dibenzo[a,5]diene Hydrochloride

    41. (2)10,d]cycloheptene-.delta.5.gamma.-propylamine, Hydrochloride

    42. 5-[(3-(methylamino)propylidene]-10,d]cycloheptene Hydrochloride

    43. 5h-dibenzo[a,.gamma.-propylamine, 10,11-dihydro-n-methyl-, Hydrochloride

    44. 5h-dibenzo[a,.gamma.-propylamine, 10-11-dihydro-n-methyl-, Hydrochloride

    45. 1-propanamine,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n-methyl-, Hydrochloride

    46. Desitriptyline Hcl

    47. 3-(5,6-dihydrodibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-n-methylpropan-1-amine;hydrochloride

    48. Prestwick_366

    49. Einecs 212-973-0

    50. Pamelor (tn)

    51. Nsc 78248

    52. Nsc 169453

    53. Cpd000058486

    54. Elf-101 Hydrochloride

    55. En-7048 Hydrochloride

    56. Nortriptyline Hydrochloride [usan:usp:jan]

    57. Opera_id_1915

    58. Dsstox_cid_25109

    59. Dsstox_rid_80676

    60. Dsstox_gsid_45109

    61. Schembl41329

    62. Mls001077267

    63. Mls002222206

    64. Mls006010656

    65. Chebi:7641

    66. Chembl1201156

    67. Dtxsid2045109

    68. Regid_for_cid_441358

    69. Hms1568d10

    70. Nortriptyline Hydrochloride- Bio-x

    71. Hy-b1417

    72. Nortriptyline For System Suitability

    73. Tox21_110048

    74. Tox21_500868

    75. Nsc-78248

    76. S3698

    77. 5-(3-(methylamino)propylidene)dibenzo(a,e)cyclohepta(1,5)diene Hydrochloride

    78. Akos015889095

    79. Ccg-212718

    80. Cs-4913

    81. Ks-1306

    82. Lp00868

    83. Nc00522

    84. 10,11-dihydro-5-(n-methyl-3-aminopropylidene)-5h-dibenzo[a,d]cycloheptene Hydrochloride

    85. 5-(3-methylaminopropylidene)-10,11-dihydro-5h-dibenzo(a,d)cycloheptene Hydrochloride

    86. Nortriptyline Hydrochloride [mi]

    87. Ncgc00014483-01

    88. Ncgc00094192-01

    89. Ncgc00094192-02

    90. Ncgc00261553-01

    91. Nortriptyline Hydrochloride [jan]

    92. 10,11-dihydro-n-methyl-5h-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine Hydrochloride

    93. Bn164160

    94. Nortriptyline Hydrochloride [hsdb]

    95. Nortriptyline Hydrochloride [usan]

    96. Nortriptyline Hydrochloride [mart.]

    97. Nortriptyline Hydrochloride [vandf]

    98. Nortriptyline Hydrochloride [usp-rs]

    99. Nortriptyline Hydrochloride [who-dd]

    100. Eu-0100868

    101. Ft-0673146

    102. Ft-0673147

    103. N0957

    104. Nortriptyline Hydrochloride (jp17/usp/inn)

    105. En300-26665

    106. D00816

    107. F19641

    108. N 7261

    109. Nortriptyline Hydrochloride [orange Book]

    110. Nortriptyline Hydrochloride [ep Monograph]

    111. Nortriptyline Hydrochloride [usp Monograph]

    112. Nortriptyline Hydrochloride, >=98% (tlc), Powder

    113. Sr-01000000223-2

    114. Sr-01000000223-7

    115. W-109609

    116. Q27231345

    117. Nortriptyline Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    118. Nortriptyline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    119. Nortriptyline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    120. 3-(10,11-2h-5h-dibenzo[a,d][7]annulen-5-ylidene)-n-methyl-1-propanaminium Chloride

    121. 3-(10,11-dihydro-5h-dibenzo[a,d][7]annulen-5-ylidene)-n-methylpropan-1-aminehydrochloride

    122. Nortriptyline For System Suitability, European Pharmacopoeia (ep) Reference Standard

    123. Nortriptyline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    124. 10,11-dihydro-n-methyl-5h-dibenzo(a,d)cycloheptene-d(sup5,.gamma.)-propylamine Hydrochloride

    125. 1001637-77-9

    126. 5h-dibenzo(a,d)cycloheptene-delta(sup 5),gamma-propylamine, 10-11-dihydro-n-methyl-, Hydrochloride

    127. Nortriptyline Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 299.8 g/mol
    Molecular Formula C19H22ClN
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count3
    Exact Mass299.1440774 g/mol
    Monoisotopic Mass299.1440774 g/mol
    Topological Polar Surface Area12 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity307
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameNortriptyline hydrochloride
    PubMed HealthNortriptyline (By mouth)
    Drug ClassesAntidepressant
    Drug LabelNortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is represented below:C19H21NHCl M.W. 299.84Nortriptyline Hydrochloride Capsules USP (equivalent to 1...
    Active IngredientNortriptyline hydrochloride
    Dosage FormCapsule; Solution
    RouteOral
    Strengtheq 50mg base; eq 75mg base; eq 10mg base/5ml; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyTeva; Pharm Assoc; Taro; Watson Labs; Mylan

    2 of 4  
    Drug NamePamelor
    Drug LabelPamelor (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene)-N-methyl-, hydrochloride.The structural formula is as follows:...
    Active IngredientNortriptyline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 75mg base; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyMallinckrodt

    3 of 4  
    Drug NameNortriptyline hydrochloride
    PubMed HealthNortriptyline (By mouth)
    Drug ClassesAntidepressant
    Drug LabelNortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is represented below:C19H21NHCl M.W. 299.84Nortriptyline Hydrochloride Capsules USP (equivalent to 1...
    Active IngredientNortriptyline hydrochloride
    Dosage FormCapsule; Solution
    RouteOral
    Strengtheq 50mg base; eq 75mg base; eq 10mg base/5ml; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyTeva; Pharm Assoc; Taro; Watson Labs; Mylan

    4 of 4  
    Drug NamePamelor
    Drug LabelPamelor (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene)-N-methyl-, hydrochloride.The structural formula is as follows:...
    Active IngredientNortriptyline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 75mg base; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyMallinckrodt

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antidepressive Agents, Tricyclic

    Substances that contain a fused three-ring moiety and are used in the treatment of depression. These drugs block the uptake of norepinephrine and serotonin into axon terminals and may block some subtypes of serotonin, adrenergic, and histamine receptors. However, the mechanism of their antidepressant effects is not clear because the therapeutic effects usually take weeks to develop and may reflect compensatory changes in the central nervous system. (See all compounds classified as Antidepressive Agents, Tricyclic.)

    Adrenergic Uptake Inhibitors

    Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Tricyclic Antidepressant [EPC]

    API Reference Price

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MAHARASHTRA","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"GLENMARK PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"278.3","totalValueFC":"28108.6","currency":"USD","unitRateINR":"23472.8","date":"10-Apr-2024","totalValueINR":"2347275","totalValueInUsd":"28108.6","indian_port":"Indore-EPZ\/SEZ","hs_no":"29214990","bill_no":"1002439","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA BISSONE 5 20021 BARANZATE DI BO LLATE MILAN 0","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"NORTRIPTYLINE HYDROCHLORIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"290.00","actualQuantity":"290","unit":"KGS","unitRateFc":"315","totalValueFC":"92397.9","currency":"USD","unitRateINR":"26633.3","date":"20-Jul-2024","totalValueINR":"7723642.5","totalValueInUsd":"92397.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4609884","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE , 5 20021 BARANZATE (MI) ITALY Milano, , ItalySDNF Italy","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"58.10","actualQuantity":"58.1","unit":"KGS","unitRateFc":"315","totalValueFC":"18512.8","currency":"USD","unitRateINR":"27074.3","date":"24-Dec-2024","totalValueINR":"1573013.93","totalValueInUsd":"18512.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7422229","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE , 5 20021 BARANZATE (MI ) ITALY Milano, , Italy SDNF Italy","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"215.60","actualQuantity":"215.6","unit":"KGS","unitRateFc":"315","totalValueFC":"68698.1","currency":"USD","unitRateINR":"27074.3","date":"24-Dec-2024","totalValueINR":"5837208.3","totalValueInUsd":"68698.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7422229","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE , 5 20021 BARANZATE (MI ) ITALY Milano, , Italy SDNF Italy","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"NORTRIPTYLINE HYDROCHLORIDE (QTY : 1 X 200 MG, VALUE USD:262) (FOC)SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740681000,"product":"NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"500.20","actualQuantity":"500.2","unit":"KGS","unitRateFc":"325","totalValueFC":"164034.1","currency":"USD","unitRateINR":"28518.8","date":"28-Feb-2025","totalValueINR":"14265078.75","totalValueInUsd":"164034.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8610325","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE , 5 20021 BARANZATE (MI ) ITALY Milano, , Italy SDNF Italy","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743705000,"product":"NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"145.30","actualQuantity":"145.3","unit":"KGS","unitRateFc":"325","totalValueFC":"47773.2","currency":"USD","unitRateINR":"28145","date":"04-Apr-2025","totalValueINR":"4089468.5","totalValueInUsd":"47773.2","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9290228","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE , 5 20021 BARANZATE (MI ) ITALY Milano, , Italy SDNF Italy","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"}]
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    ABOUT THIS PAGE

    Looking for 1001637-77-9 / Nortriptyline API manufacturers, exporters & distributors?

    Nortriptyline manufacturers, exporters & distributors 1

    28

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

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

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

    API | Excipient name

    Nortriptyline

    Synonyms

    894-71-3, Nortriptyline hcl, Pamelor, Desmethylamitriptyline hydrochloride, Allegron, Acetexa

    Cas Number

    1001637-77-9

    Unique Ingredient Identifier (UNII)

    00FN6IH15D

    About Nortriptyline

    A metabolite of AMITRIPTYLINE that is also used as an antidepressive agent. Nortriptyline is used in major depression, dysthymia, and atypical depressions.

    00FN6IH15D Manufacturers

    A 00FN6IH15D manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 00FN6IH15D, including repackagers and relabelers. The FDA regulates 00FN6IH15D manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 00FN6IH15D 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 00FN6IH15D manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    00FN6IH15D Suppliers

    A 00FN6IH15D supplier is an individual or a company that provides 00FN6IH15D active pharmaceutical ingredient (API) or 00FN6IH15D finished formulations upon request. The 00FN6IH15D suppliers may include 00FN6IH15D API manufacturers, exporters, distributors and traders.

    click here to find a list of 00FN6IH15D suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    00FN6IH15D USDMF

    A 00FN6IH15D DMF (Drug Master File) is a document detailing the whole manufacturing process of 00FN6IH15D active pharmaceutical ingredient (API) in detail. Different forms of 00FN6IH15D DMFs exist exist since differing nations have different regulations, such as 00FN6IH15D USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A 00FN6IH15D DMF submitted to regulatory agencies in the US is known as a USDMF. 00FN6IH15D USDMF includes data on 00FN6IH15D's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 00FN6IH15D USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of 00FN6IH15D suppliers with USDMF on PharmaCompass.

    00FN6IH15D 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 00FN6IH15D Drug Master File in Japan (00FN6IH15D JDMF) empowers 00FN6IH15D 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 00FN6IH15D JDMF during the approval evaluation for pharmaceutical products. At the time of 00FN6IH15D 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 00FN6IH15D suppliers with JDMF on PharmaCompass.

    00FN6IH15D KDMF

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

    Pharmaceutical companies submit a 00FN6IH15D Drug Master File in Korea (00FN6IH15D KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 00FN6IH15D. The MFDS reviews the 00FN6IH15D KDMF as part of the drug registration process and uses the information provided in the 00FN6IH15D KDMF to evaluate the safety and efficacy of the drug.

    After submitting a 00FN6IH15D 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 00FN6IH15D API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of 00FN6IH15D suppliers with KDMF on PharmaCompass.

    00FN6IH15D CEP

    A 00FN6IH15D CEP of the European Pharmacopoeia monograph is often referred to as a 00FN6IH15D Certificate of Suitability (COS). The purpose of a 00FN6IH15D CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 00FN6IH15D EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 00FN6IH15D to their clients by showing that a 00FN6IH15D CEP has been issued for it. The manufacturer submits a 00FN6IH15D CEP (COS) as part of the market authorization procedure, and it takes on the role of a 00FN6IH15D CEP holder for the record. Additionally, the data presented in the 00FN6IH15D CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 00FN6IH15D DMF.

    A 00FN6IH15D CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 00FN6IH15D 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 00FN6IH15D suppliers with CEP (COS) on PharmaCompass.

    00FN6IH15D WC

    A 00FN6IH15D written confirmation (00FN6IH15D WC) is an official document issued by a regulatory agency to a 00FN6IH15D manufacturer, verifying that the manufacturing facility of a 00FN6IH15D active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 00FN6IH15D APIs or 00FN6IH15D finished pharmaceutical products to another nation, regulatory agencies frequently require a 00FN6IH15D WC (written confirmation) as part of the regulatory process.

    click here to find a list of 00FN6IH15D suppliers with Written Confirmation (WC) on PharmaCompass.

    00FN6IH15D 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 00FN6IH15D as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for 00FN6IH15D 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 00FN6IH15D 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 00FN6IH15D and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 00FN6IH15D NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of 00FN6IH15D suppliers with NDC on PharmaCompass.

    00FN6IH15D GMP

    00FN6IH15D 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 00FN6IH15D 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 00FN6IH15D GMP manufacturer or 00FN6IH15D GMP API supplier for your needs.

    00FN6IH15D CoA

    A 00FN6IH15D CoA (Certificate of Analysis) is a formal document that attests to 00FN6IH15D's compliance with 00FN6IH15D specifications and serves as a tool for batch-level quality control.

    00FN6IH15D CoA mostly includes findings from lab analyses of a specific batch. For each 00FN6IH15D 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.

    00FN6IH15D may be tested according to a variety of international standards, such as European Pharmacopoeia (00FN6IH15D EP), 00FN6IH15D JP (Japanese Pharmacopeia) and the US Pharmacopoeia (00FN6IH15D 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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