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    Also known as: 41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol
    Molecular Formula
    C12H22ClN
    Molecular Weight
    215.76  g/mol
    InChI Key
    LDDHMLJTFXJGPI-UHFFFAOYSA-N
    FDA UNII
    JY0WD0UA60
    Memantine Hydrochloride
    AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.
    1 2D Structure

    Memantine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3,5-dimethyladamantan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C12H21N.ClH/c1-10-3-9-4-11(2,6-10)8-12(13,5-9)7-10;/h9H,3-8,13H2,1-2H3;1H
    2.1.3 InChI Key
    LDDHMLJTFXJGPI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC12CC3CC(C1)(CC(C3)(C2)N)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    JY0WD0UA60
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1,3-dimethyl-5-aminoadamantane

    2. 1-amino-3,5-dimethyladamantane

    3. Axura

    4. D 145

    5. D-145

    6. D145

    7. Ebixa

    8. Memantin

    9. Memantine

    10. Namenda

    2.3.2 Depositor-Supplied Synonyms

    1. 41100-52-1

    2. Memantine Hcl

    3. Namenda

    4. 3,5-dimethyl-1-adamantanamine Hydrochloride

    5. 3,5-dimethyladamantan-1-amine Hydrochloride

    6. Akatinol

    7. Axura

    8. Namenda Xr

    9. Memary

    10. Ebixa

    11. Memantine Mylan

    12. 1-amino-3,5-dimethyladamantane Hydrochloride

    13. Memantine Merz

    14. Memantine.hcl

    15. Memantine Accord

    16. Memantine Lek

    17. Memantine (hydrochloride)

    18. Acrescent

    19. Balaxur

    20. Auxura

    21. Unii-jy0wd0ua60

    22. 3,5-dimethyladamantan-1-amine;hydrochloride

    23. Jy0wd0ua60

    24. Mfcd00214336

    25. Memantine Ratiopharm

    26. Memantine Hydrochloride [usan]

    27. Chebi:64323

    28. Sun-y7017

    29. Nsc-102290

    30. 3,5-dimethyladamantan-1-aminium Chloride

    31. D-145

    32. Mls001332605

    33. 3,5-dimethyl-1-aminoadamantane Hydrochloride

    34. (3,5-dimethyl-1-adamantyl)amine Hydrochloride

    35. 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine Hydrochloride

    36. Fp-01

    37. 1,3-dimethyl-5-adamantanamine Hcl

    38. 3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

    39. 41100-52-1 (hcl)

    40. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride

    41. D 145

    42. Mantine

    43. Ebixza

    44. 3,5-dimethyl-tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

    45. 3,5-dimethyltricyclo(3.3.1.13,7)decan-1-amine Hydrochloride

    46. 3,5-dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine Hydrochloride

    47. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

    48. 3,5-dimethyl-1-adamantylamine

    49. 3,5-dimethyl-1-aminoadamantane

    50. Smr000875213

    51. Sr-01000075458

    52. Sun Y7017

    53. Einecs 255-219-6

    54. Namenda (tn)

    55. Memary (tn)

    56. Marixino

    57. Nsc 102290

    58. D-145 (hydrochloride)

    59. Schembl3053

    60. C12h21n.hcl

    61. Chembl1699

    62. Mls001332606

    63. Spectrum1501121

    64. Hy-b0365a

    65. Dtxsid90961439

    66. Memantine Hydrochloride (namenda)

    67. N06dx01

    68. Nmi-131

    69. Hms1571c17

    70. Hms1921h03

    71. Pharmakon1600-01501121

    72. Memantine Hydrochloride (jan/usp)

    73. Memantine Hydrochloride [mi]

    74. Tox21_500861

    75. Ac-559

    76. Ccg-39018

    77. Memantine Hydrochloride [jan]

    78. Mrz-2/145

    79. Nsc102290

    80. Nsc757843

    81. S2043

    82. Akos015889460

    83. Bcp9000253

    84. Lp00861

    85. Memantine Hydrochloride [mart.]

    86. Nc00680

    87. Memantine Hydrochloride [usp-rs]

    88. Memantine Hydrochloride [who-dd]

    89. Ncgc00094186-01

    90. Ncgc00094186-02

    91. Ncgc00094186-03

    92. Ncgc00261546-01

    93. As-13331

    94. Bm164662

    95. Memantine Hydrochloride [ema Epar]

    96. Sy057917

    97. 3,5-dimethyladamantan-1-aminehydrochloride

    98. Am20070534

    99. D3608

    100. Eu-0100861

    101. Ft-0650723

    102. M-145

    103. Memantine Hydrochloride [orange Book]

    104. Sw060653-4

    105. 1-amino-3,5-dimethyl-adamantane Hydrochloride

    106. 3,5-dimethyladamantan-1-amine Hy-drochloride

    107. 3,5-dimethyladamantan-1-amine;hydrochloride.

    108. D04905

    109. M 9292

    110. Memantine Hydrochloride [usp Monograph]

    111. Namzaric Component Memantine Hydrochloride

    112. Memantine Hydrochloride Component Of Namzaric

    113. Sr-01000075458-1

    114. Sr-01000075458-3

    115. Sr-01000075458-8

    116. Q27133218

    117. Z1551429722

    118. Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

    119. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride (1:1) (ca Index Name)

    120. 1-amino-3,5-dimethyladamantane . Hcl 3,5-dimethyl-1-aminoadamantane . Hcl Memantine . Hydrochloride

    2.4 Create Date
    2005-07-19
    3 Chemical and Physical Properties
    Molecular Weight 215.76 g/mol
    Molecular Formula C12H22ClN
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count0
    Exact Mass215.1440774 g/mol
    Monoisotopic Mass215.1440774 g/mol
    Topological Polar Surface Area26 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity240
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameMemantine hydrochloride
    PubMed HealthMemantine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
    Active IngredientMemantine hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 10mg
    Market StatusTentative Approval
    CompanyAmneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

    2 of 6  
    Drug NameNamenda
    PubMed HealthMemantine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
    Active IngredientMemantine hydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2mg/ml; 5mg; 10mg
    Market StatusPrescription
    CompanyForest Labs

    3 of 6  
    Drug NameNamenda xr
    Drug LabelNAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
    Active IngredientMemantine hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength7mg; 14mg; 21mg; 28mg
    Market StatusPrescription
    CompanyForest Labs

    4 of 6  
    Drug NameMemantine hydrochloride
    PubMed HealthMemantine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
    Active IngredientMemantine hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 10mg
    Market StatusTentative Approval
    CompanyAmneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

    5 of 6  
    Drug NameNamenda
    PubMed HealthMemantine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
    Active IngredientMemantine hydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2mg/ml; 5mg; 10mg
    Market StatusPrescription
    CompanyForest Labs

    6 of 6  
    Drug NameNamenda xr
    Drug LabelNAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
    Active IngredientMemantine hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength7mg; 14mg; 21mg; 28mg
    Market StatusPrescription
    CompanyForest Labs

    4.2 Drug Indication

    Treatment of patients with moderate to severe Alzheimer's disease.

    Treatment of patients with moderate to severe Alzheimers disease.

    Treatment of patients with moderate to severe Alzheimers disease.

    Treatment of patients with moderate to severe Alzheimers disease.

    Treatment of patients with moderate to severe Alzheimer's disease.

    Treatment of patients with moderate to severe Alzheimers disease

    Treatment of patients with moderate to severe Alzheimers disease.

    Treatment of patients with moderate to severe Alzheimers disease.

    Treatment of Alzheimers disease

    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.)

    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.)

    Excitatory Amino Acid Antagonists

    Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    NMDA Receptor Antagonists [MoA]; N-methyl-D-aspartate Receptor Antagonist [EPC]
    5.3 ATC Code

    N06DX01

    N06DX01

    N06DX01

    N06DX01

    N06DX01

    N06DX01

    N06DX01

    N06DX01

    N06D

    N06DA52

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SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ANONIMA MATERIE SINTETICHE E AFFINI SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"650","totalValueFC":"54062.3","currency":"EURO","unitRateINR":"60255","date":"26-Jul-2024","totalValueINR":"4519125","totalValueInUsd":"54062.3","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"4718638","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"MEMANTINE HYDROCHLORIDE I.P, U.S.P.","address":"ZYDUS TOWER, 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SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ANONIMA MATERIE SINTETICHE E AFFINI SPA","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"43.20","actualQuantity":"43.2","unit":"KGS","unitRateFc":"625","totalValueFC":"29051.5","currency":"EURO","unitRateINR":"56750","date":"29-Nov-2024","totalValueINR":"2451600","totalValueInUsd":"29051.5","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"6951825","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"MEMANTINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ANONIMA MATERIE SINTETICHE E AFFINI SPA","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"156.80","actualQuantity":"156.8","unit":"KGS","unitRateFc":"625","totalValueFC":"105446","currency":"EURO","unitRateINR":"56750","date":"29-Nov-2024","totalValueINR":"8898400","totalValueInUsd":"105446","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"6951825","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738693800,"product":"MEMANTINE HYDROCHLORIDE, USP MEMANTINE HYDROCHLORIDE, USP","address":"5-7-53, SANGEETHNAGAR","city":"HYDERABAD-A,P,","supplier":"JSC OLPHA","supplierCountry":"LATVIA","foreign_port":"RIGA","customer":"PELLETS PHARMA LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"680","totalValueFC":"102159.4","currency":"USD","unitRateINR":"59228","date":"05-Feb-2025","totalValueINR":"8884200","totalValueInUsd":"102159.4","indian_port":"Hyderabad Air","hs_no":"29213090","bill_no":"8189081","productDescription":"API","marketType":"REGULATED MARKET","country":"LATVIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RIGA","supplierAddress":"5,RUPNICU STREET, OLAINE, LV-2114 SDNF LATVIA","customerAddress":"5-7-53, SANGEETHNAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741199400,"product":"MEMANTINE HYDROCHLORIDE I.P., U.S.P. MEMANTINE HYDROCHLORIDE I.P., U.S.P.","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"ANONIMA MATERIE SINTETICHE E AFFINI SPA","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"657.4","totalValueFC":"83250.3","currency":"EURO","unitRateINR":"57687.5","date":"06-Mar-2025","totalValueINR":"7210937.5","totalValueInUsd":"83250.3","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"8732201","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, , Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"MEMANTINE HYDROCHLORIDE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"AMSAANONIMA MATERIE SINTETICHE & AFFINI SPA","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"800","totalValueFC":"80630.3","currency":"USD","unitRateINR":"69840","date":"27-Mar-2025","totalValueINR":"6984000","totalValueInUsd":"80630.3","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29213090","bill_no":"9131988","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"VIA G.DI VITTORIO 6 22100 COMO ITAL VIA G.DI VITTORIO 6 22100 COMO ITAL SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744914600,"product":"MEMANTINE HCL USP","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"62.18","actualQuantity":"62.18","unit":"KGS","unitRateFc":"508.5","totalValueFC":"31914.5","currency":"USD","unitRateINR":"43936","date":"18-Apr-2025","totalValueINR":"2731940.48","totalValueInUsd":"31914.5","indian_port":"Vizag-HIPL SEZ","hs_no":"29213090","bill_no":"9569337","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"98, GOVT.INDUSTRIAL AREA,"}]
    06-Jan-2022
    23-Apr-2025
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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21487

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 21487

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG

    USFDA APPLICATION NUMBER - 22525

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG

    USFDA APPLICATION NUMBER - 22525

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG

    USFDA APPLICATION NUMBER - 22525

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22525

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    ABOUT THIS PAGE

    Looking for 41100-52-1 / Memantine Hydrochloride API manufacturers, exporters & distributors?

    Memantine Hydrochloride manufacturers, exporters & distributors 1

    24

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

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

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

    API | Excipient name

    Memantine Hydrochloride

    Synonyms

    41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

    Cas Number

    41100-52-1

    Unique Ingredient Identifier (UNII)

    JY0WD0UA60

    About Memantine Hydrochloride

    AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

    Namenda Manufacturers

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

    Namenda Suppliers

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

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

    Namenda USDMF

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

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

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

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

    Namenda KDMF

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

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

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

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

    Namenda WC

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

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

    Namenda 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 Namenda as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Namenda GMP

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

    Namenda CoA

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

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

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