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    Chemistry

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    Also known as: 665-66-7, 1-adamantanamine hydrochloride, Amantadine hcl, Symmetrel, 1-aminoadamantane hydrochloride, Adamantan-1-amine hydrochloride
    Molecular Formula
    C10H18ClN
    Molecular Weight
    187.71  g/mol
    InChI Key
    WOLHOYHSEKDWQH-UHFFFAOYSA-N
    FDA UNII
    M6Q1EO9TD0
    Amantadine Hydrochloride
    An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.
    1 2D Structure

    Amantadine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    adamantan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C10H17N.ClH/c11-10-4-7-1-8(5-10)3-9(2-7)6-10;/h7-9H,1-6,11H2;1H
    2.1.3 InChI Key
    WOLHOYHSEKDWQH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1C2CC3CC1CC(C2)(C3)N.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    M6Q1EO9TD0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1 Aminoadamantane

    2. 1-aminoadamantane

    3. Adamantylamine

    4. Adekin

    5. Al, Amantadin

    6. Aman

    7. Amanta

    8. Amanta Hci Azu

    9. Amanta-hci-azu

    10. Amantadin Al

    11. Amantadin Azu

    12. Amantadin Neuraxpharm

    13. Amantadin Ratiopharm

    14. Amantadin Stada

    15. Amantadin-neuraxpharm

    16. Amantadin-ratiopharm

    17. Amantadina Juventus

    18. Amantadina Llorente

    19. Amantadine

    20. Amantadinneuraxpharm

    21. Amantadinratiopharm

    22. Amantahciazu

    23. Amixx

    24. Azu, Amantadin

    25. Cerebramed

    26. Endantadine

    27. Gen Amantadine

    28. Gen-amantadine

    29. Genamantadine

    30. Hydrochloride, Amantadine

    31. Infecto Flu

    32. Infecto-flu

    33. Infectoflu

    34. Infex

    35. Juventus, Amantadina

    36. Llorente, Amantadina

    37. Mantadix

    38. Midantan

    39. Pms Amantadine

    40. Pms-amantadine

    41. Pmsamantadine

    42. Stada, Amantadin

    43. Symadine

    44. Symmetrel

    45. Tregor

    46. Viregyt

    47. Wiregyt

    2.3.2 Depositor-Supplied Synonyms

    1. 665-66-7

    2. 1-adamantanamine Hydrochloride

    3. Amantadine Hcl

    4. Symmetrel

    5. 1-aminoadamantane Hydrochloride

    6. Adamantan-1-amine Hydrochloride

    7. 1-adamantylamine Hydrochloride

    8. Adamantanamine Hydrochloride

    9. Amazolon

    10. Midantan

    11. Midantane

    12. Mydantane

    13. Virofral

    14. Symadine

    15. Influenol

    16. Mantadix

    17. Trivaline

    18. Amantan

    19. Virasol

    20. Viregyt

    21. Virosol

    22. Amantadine (hydrochloride)

    23. 1-adamantanamine, Hydrochloride

    24. Adamantylamine Hydrochloride

    25. Aminoadamantane Hydrochloride

    26. Adamantine Hydrochloride

    27. Exp-105-1

    28. 1-adamantanamine Hcl

    29. Exp 105-1

    30. Nsc 83653

    31. Osmolex

    32. Mfcd00074723

    33. Nsc-83653

    34. Adamantan-1-amine;hydrochloride

    35. Mls000028731

    36. Gp 38026

    37. Tricyclo[3.3.1.13,7]decan-1-amine, Hydrochloride

    38. M6q1eo9td0

    39. Ads-5102

    40. Amantadine Hydrochloride (symmetrel)

    41. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, Hydrochloride

    42. Smr000059204

    43. 665-66-7 (hcl)

    44. Tricyclo(3.3.1.13,7)decan-1-amine, Hydrochloride

    45. Adamantan-1-aminium Chloride

    46. Chebi:2619

    47. 1-adamantanamine Hydrochloride;1-adamantylamine Hydrochloride;1-aminoadamantane Hydrochloride

    48. 1-adamantanaminehydrochloride

    49. 1-aminoadamantene Hydrochloride

    50. Nsc83653

    51. Einecs 211-560-2

    52. Unii-m6q1eo9td0

    53. Cerebramed

    54. Adamine

    55. Hofcomant

    56. Lysovir

    57. Mantadan

    58. Mantadine

    59. Nurelin

    60. Adamin

    61. Ai3-52211

    62. Sr-01000075353

    63. Symmetrel (tn)

    64. Osmolex Er (tn)

    65. Gocovri (tn)

    66. Amantadinehydrochloride

    67. Amantadine Hydrochloride [usan:usp:jan]

    68. Opera_id_671

    69. Adamantamine Hydrochloride

    70. Ec 211-560-2

    71. Adamantyl Amine Hydrochloride

    72. 1-adamantanamin Hydrochlorid

    73. C10h17n.hcl

    74. Chembl1569

    75. Schembl40713

    76. Adamantan-1-aminehydrochloride

    77. Mls002153257

    78. Mls003899199

    79. Spectrum1500110

    80. Hy-b0402a

    81. 1-aminoada- Mantane Hydrochloride

    82. Amy3568

    83. Dtxsid50874031

    84. N04bb01

    85. Hms1920a19

    86. Pharmakon1600-01500110

    87. Ads-5101

    88. Bcp11857

    89. Str01017

    90. Tox21_500004

    91. A3a501

    92. Amantadine Hydrochloride [mi]

    93. Ccg-38899

    94. Nsc755860

    95. S2451

    96. Tricyclo[3.3.1.13, Hydrochloride

    97. Amantadine Hydrochloride (jp17/usp)

    98. Amantadine Hydrochloride [jan]

    99. Akos015900347

    100. Akos015951188

    101. Ac-8689

    102. Amantadine Hydrochloride [usan]

    103. Lp00004

    104. Nc00489

    105. Nsc-755860

    106. Amantadine Hydrochloride [mart.]

    107. Amantadine Hydrochloride [vandf]

    108. 1-adamantylammonium;1-adamantanamine Hcl

    109. Amantadine Hydrochloride [usp-rs]

    110. Amantadine Hydrochloride [who-dd]

    111. Ncgc00093531-01

    112. Ncgc00093531-02

    113. Ncgc00093531-03

    114. Ncgc00093531-04

    115. Ncgc00260689-01

    116. Ba166177

    117. Smr001370746

    118. A0588

    119. Eu-0100004

    120. Ft-0622248

    121. Sw219892-1

    122. (3r,5s,7s)-adamantan-1-amine Hydrochloride

    123. Amantadine Hydrochloride [orange Book]

    124. A 1260

    125. Amantadine Hydrochloride [ep Monograph]

    126. Amantadine Hydrochloride [usp Monograph]

    127. C07939

    128. D00777

    129. F15409

    130. Wln: L66 B6 A B- C 1b Itj Bz &gh

    131. A835493

    132. Amantadine Hydrochlorid 100 Microg/ml In Methanol

    133. Amantadine Hydrochloride 1000 Microg/ml In Methanol

    134. J-650095

    135. J-650235

    136. Q-200621

    137. Sr-01000075353-1

    138. Tricyclo[3.3.1.1 3,7]decan-1-amine Hydrochloride

    139. Tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

    140. Q27105739

    141. F3111-1111

    142. Tricyclo(3.3.1.13,7)decan-1-amine, Hydrochloride (1:1)

    143. Amantadine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    144. Amantadine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    145. Amantadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    146. 1-aminoadamantane Hydrochloride; 1-adamantanamine Hydrochloride; 1-adamantylamine Hydrochloride

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 187.71 g/mol
    Molecular Formula C10H18ClN
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count0
    Exact Mass187.1127773 g/mol
    Monoisotopic Mass187.1127773 g/mol
    Topological Polar Surface Area26 Ų
    Heavy Atom Count12
    Formal Charge0
    Complexity144
    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 2  
    Drug NameAmantadine hydrochloride
    Drug LabelAmantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in...
    Active IngredientAmantadine hydrochloride
    Dosage FormTablet; Syrup; Capsule
    RouteOral
    Strength100mg; 50mg/5ml
    Market StatusPrescription
    CompanyWockhardt; Silarx; Hi Tech Pharma; Carolina Medcl; Pharm Assoc; Vintage; Usl Pharma; Banner Pharmacaps; Sandoz; Mikart

    2 of 2  
    Drug NameAmantadine hydrochloride
    Drug LabelAmantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in...
    Active IngredientAmantadine hydrochloride
    Dosage FormTablet; Syrup; Capsule
    RouteOral
    Strength100mg; 50mg/5ml
    Market StatusPrescription
    CompanyWockhardt; Silarx; Hi Tech Pharma; Carolina Medcl; Pharm Assoc; Vintage; Usl Pharma; Banner Pharmacaps; Sandoz; Mikart

    4.2 Drug Indication

    Treatment of Parkinson's disease and parkinsonism

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antiparkinson Agents

    Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

    Antiviral Agents

    Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

    Analgesics, Non-Narcotic

    A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)

    Dopamine Agents

    Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    M2 Protein Inhibitors [MoA]; Influenza A M2 Protein Inhibitor [EPC]

    API Reference Price

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CESAR MARTINELL I BRUNET, 12A 08191 RUBI BARCELONA SPAIN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750271400,"product":"AMANTADINE HYDROCHLORIDE ( NOTIFY - GPAX PHARMACEUT ICALS PVTLTD ,PLOTNO-646\/1&2 DABHEL, NANI DAMAN. )AMANTADINE HYDROCHLORIDE","address":"ASTER FLAT NO 402 REGENCY GARDENS,","city":"KHARGHAR,MAHARASHTRA","supplier":"CIDIC CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"PROSFORA TECHNOLOGIES PRIVATE LTD","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"25","totalValueFC":"3786","currency":"USD","unitRateINR":"2168.8","date":"19-Jun-2025","totalValueINR":"325312.5","totalValueInUsd":"3786","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"2748102","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"15\/F, HODO INTERNATIONAL PLAZA, 531 ZHONGSHAN ROAD WUXI 214002 CHINA SDNF CHINA","customerAddress":"ASTER FLAT NO 402 REGENCY GARDENS,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750444200,"product":"AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE","address":"PLOT NO. 1A, SECTOR 16A,","city":"NOIDA U.P.","supplier":"MOEHS CATALANA SL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"JUBILANT GENERICS LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"296","totalValueFC":"12077.6","currency":"USD","unitRateINR":"25944.4","date":"21-Jun-2025","totalValueINR":"1037776","totalValueInUsd":"12077.6","indian_port":"Delhi Air","hs_no":"29213090","bill_no":"2810856","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. RUBI SUR - CESAR MARTINELL I BRUNET, 12A 08191 RUBI BARCELONA, SPAIN","customerAddress":"PLOT NO. 1A, SECTOR 16A,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"AMANTADINE HYDRO CHLORIDE CHEMICAL","address":"PLOT NO 23 D , APIIC LALAMKODORU,R","city":"VISAKHAPATNAM,ANDHRA PRADESH","supplier":"ZHEJIANG HENGDIAN APELOA IMP.& EXP.CO., LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"VINTALABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"6500.00","actualQuantity":"6500","unit":"KGS","unitRateFc":"8.6","totalValueFC":"57022","currency":"USD","unitRateINR":"753.8","date":"27-Jun-2025","totalValueINR":"4899635","totalValueInUsd":"57022","indian_port":"Vizag Sea","hs_no":"29213090","bill_no":"2924790","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"13F,T1 HENGDIAN CENTER, NO.136 FUCHUN ROAD,SHANGCHENG DISTRICT, HANGZHOU, CHINA CN","customerAddress":"PLOT NO 23 D , APIIC LALAMKODORU,R"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"AMANTADINE HYDROCHLORIDE CHEMICAL","address":"PLOT NO 23 D , APIIC LALAMKODORU,R","city":"VISAKHAPATNAM,ANDHRA PRADESH","supplier":"ZHEJIANG HENGDIAN APELOA IMP.& EXP.CO., LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"VINTALABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"3500.00","actualQuantity":"3500","unit":"KGS","unitRateFc":"8.8","totalValueFC":"31318.2","currency":"USD","unitRateINR":"768.9","date":"27-Jun-2025","totalValueINR":"2691030","totalValueInUsd":"31318.2","indian_port":"Vizag Sea","hs_no":"29213090","bill_no":"2924171","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"13F T1 HENGDIAN CENTER NO.136 FUCHUN ROAD,SHANGCHENG DISTRICT, HANGZHOU, CHINA CN","customerAddress":"PLOT NO 23 D , APIIC LALAMKODORU,R"}]
    10-Jan-2022
    27-Jun-2025
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    South Africa

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    Novartis South Africa (Pty) Ltd

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    Regulatory Info : Originator

    Registration Country : South Africa

    Amantadine

    Brand Name : Symmetrel

    Dosage Form : CAP

    Dosage Strength : 100mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 129MG BASE

    USFDA APPLICATION NUMBER - 209410

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 161MG BASE

    USFDA APPLICATION NUMBER - 209410

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 193MG BASE

    USFDA APPLICATION NUMBER - 209410

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 258MG BASE

    USFDA APPLICATION NUMBER - 209410

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    ABOUT THIS PAGE

    Looking for 665-66-7 / Amantadine Hydrochloride API manufacturers, exporters & distributors?

    Amantadine Hydrochloride manufacturers, exporters & distributors 1

    58

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

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

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

    API | Excipient name

    Amantadine Hydrochloride

    Synonyms

    665-66-7, 1-adamantanamine hydrochloride, Amantadine hcl, Symmetrel, 1-aminoadamantane hydrochloride, Adamantan-1-amine hydrochloride

    Cas Number

    665-66-7

    Unique Ingredient Identifier (UNII)

    M6Q1EO9TD0

    About Amantadine Hydrochloride

    An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.

    Trivaline Manufacturers

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

    Trivaline Suppliers

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

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

    Trivaline USDMF

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

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

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

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

    Trivaline CEP

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

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

    Trivaline 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 Trivaline as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Trivaline GMP

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

    Trivaline CoA

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

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

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