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    Chemistry

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    Also known as: 120011-70-3, Donepezil hcl, Aricept, Bnag, 110119-84-1, 2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one hydrochloride
    Molecular Formula
    C24H30ClNO3
    Molecular Weight
    416.0  g/mol
    InChI Key
    XWAIAVWHZJNZQQ-UHFFFAOYSA-N
    FDA UNII
    3O2T2PJ89D
    Donepezil
    An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.
    1 2D Structure

    Donepezil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C24H29NO3.ClH/c1-27-22-14-19-13-20(24(26)21(19)15-23(22)28-2)12-17-8-10-25(11-9-17)16-18-6-4-3-5-7-18;/h3-7,14-15,17,20H,8-13,16H2,1-2H3;1H
    2.1.3 InChI Key
    XWAIAVWHZJNZQQ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC1=C(C=C2C(=C1)CC(C2=O)CC3CCN(CC3)CC4=CC=CC=C4)OC.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    3O2T2PJ89D
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine Hydrochloride

    2. Aricept

    3. Donepezil

    4. Donepezilium Oxalate Trihydrate

    5. E 2020

    6. E-2020

    7. E2020

    8. Eranz

    2.3.2 Depositor-Supplied Synonyms

    1. 120011-70-3

    2. Donepezil Hcl

    3. Aricept

    4. Bnag

    5. 110119-84-1

    6. 2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one Hydrochloride

    7. E2020

    8. Donepezilhcl

    9. E-2020

    10. Aricept Odt

    11. E 2020

    12. Donepezil (hydrochloride)

    13. Donepezil, Hcl

    14. 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1h-inden-1-one Hydrochloride

    15. Nsc-737535

    16. Nsc-758882

    17. Chembl1678

    18. 3o2t2pj89d

    19. 2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one;hydrochloride

    20. 2-(1-benzyl-4-piperidylmethyl)-5,6-dimethoxy-1-indanone Hydrochloride

    21. 120011-70-3 (hcl)

    22. E2020;e-2020

    23. Dsstox_cid_26698

    24. Dsstox_rid_81832

    25. Dsstox_gsid_46698

    26. 1h-inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-, Hydrochloride (1:1)

    27. Eranz

    28. 2-(1-benzyl-piperidin-4-ylmethyl)-5,6-dimethoxy-indan-1-one Hydrochloride

    29. E 2020 (pharmaceutical)

    30. Smr000449292

    31. Cas-120011-70-3

    32. Donepezil Hydrochloride [usan]

    33. Nsc 737535

    34. Nsc 758882

    35. Ncgc00167537-01

    36. Unii-3o2t2pj89d

    37. Memorit

    38. Memac

    39. Aricept Evess

    40. Donepezil,hcl

    41. Aricept D

    42. (+/-)-2-((1-benzyl-4-piperidyl)methyl)-5,6-dimethoxy-1-indanone Hydrochloride

    43. (+/-)-2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Hydrochloride

    44. Aricept (tn)

    45. Donepezil Hydrochloride [usan:usp]

    46. Adlarity

    47. Donepezil, Hydrochloride

    48. 1-benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine Hcl

    49. Donepezil Hcl (aricept)

    50. Donepezil Hcl - Bio-x

    51. Schembl1815

    52. Donepezil Hydrochloride,(s)

    53. Mls000758276

    54. Mls001401387

    55. Chebi:4696

    56. Dtxsid0046698

    57. Pharmakon1600-01504403

    58. Act02683

    59. Amy40527

    60. Bcp02205

    61. Bcp24884

    62. Hy-b0034

    63. Donepezil Hydrochloride [mi]

    64. Tox21_112534

    65. Ac-913

    66. Donepezil Hydrochloride (jp17/usp)

    67. Donepezil Hydrochloride [jan]

    68. Mfcd00881312

    69. Nsc737535

    70. Nsc758882

    71. S2462

    72. Akos000277343

    73. Akos016340656

    74. Tox21_112534_1

    75. Ccg-101043

    76. Ccg-213309

    77. Cs-0863

    78. Donepezil Hydrochloride [mart.]

    79. Donepezil Hydrochloride [vandf]

    80. Ks-1051

    81. Nc00293

    82. (+-)-2-((1-benzyl-4-piperidyl)methyl)-5,6-dimethoxy-1-indanone Hydrochloride

    83. Donepezil Hydrochloride [usp-rs]

    84. Donepezil Hydrochloride [who-dd]

    85. Ncgc00167537-02

    86. 1h-inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-((1-(phenylmethyl)-4-piperidinyl)methyl)-, Hydrochloride

    87. Bd164380

    88. D4099

    89. Donepezil Hydrochloride [orange Book]

    90. Ft-0602354

    91. Ft-0625589

    92. Donepezil Hydrochloride [ep Monograph]

    93. D00670

    94. Donepezil Hydrochloride [usp Monograph]

    95. E-2022

    96. Namzaric Component Donepezil Hydrochloride

    97. 119d841

    98. A804411

    99. Donepezil Hydrochloride Component Of Namzaric

    100. Donepezil Hydrochloride Monohydrate, >=98% (hplc)

    101. Q-100096

    102. Q-201040

    103. Q27106438

    104. Donepezil Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    105. 2,3-dihydro-5,6-dimethoxy-2-((1-(phenylmethyl)-4-piperidinyl)methyl)-1h-inden-1-one Hcl

    106. 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]-1h-inden-1-one

    107. (+-)-2,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1h-inden-1-one Hydrochloride

    108. 2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one Hydrochloride 120014-06-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 416.0 g/mol
    Molecular Formula C24H30ClNO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count6
    Exact Mass415.1914215 g/mol
    Monoisotopic Mass415.1914215 g/mol
    Topological Polar Surface Area38.8 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity510
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameAricept
    PubMed HealthDonepezil (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as ()-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is c...
    Active IngredientDonepezil hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 23mg; 10mg
    Market StatusPrescription
    CompanyEisai

    2 of 4  
    Drug NameDonepezil hydrochloride
    Drug LabelDonepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as ()-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly refe...
    Active IngredientDonepezil hydrochloride
    Dosage FormTablet, orally disintegrating; Tablet
    Routeoral; Oral
    Strength5mg; 23mg; 10mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Mylan Pharms; Ranbaxy; Macleods Pharms; Jubilant Generics; Vivimed Labs; Teva; Apotex; Aurobindo; Indicus Pharma; Alembic Pharms; Cspc Ouyi Pharm; Sun Pharm Inds; Pliva Hrvatska Doo; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Pri

    3 of 4  
    Drug NameAricept
    PubMed HealthDonepezil (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as ()-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is c...
    Active IngredientDonepezil hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 23mg; 10mg
    Market StatusPrescription
    CompanyEisai

    4 of 4  
    Drug NameDonepezil hydrochloride
    Drug LabelDonepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as ()-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly refe...
    Active IngredientDonepezil hydrochloride
    Dosage FormTablet, orally disintegrating; Tablet
    Routeoral; Oral
    Strength5mg; 23mg; 10mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Mylan Pharms; Ranbaxy; Macleods Pharms; Jubilant Generics; Vivimed Labs; Teva; Apotex; Aurobindo; Indicus Pharma; Alembic Pharms; Cspc Ouyi Pharm; Sun Pharm Inds; Pliva Hrvatska Doo; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Pri

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Cholinesterase Inhibitors

    Drugs that inhibit cholinesterases. The neurotransmitter ACETYLCHOLINE is rapidly hydrolyzed, and thereby inactivated, by cholinesterases. When cholinesterases are inhibited, the action of endogenously released acetylcholine at cholinergic synapses is potentiated. Cholinesterase inhibitors are widely used clinically for their potentiation of cholinergic inputs to the gastrointestinal tract and urinary bladder, the eye, and skeletal muscles; they are also used for their effects on the heart and the central nervous system. (See all compounds classified as Cholinesterase Inhibitors.)

    Nootropic Agents

    Drugs used to specifically facilitate learning or memory, particularly to prevent the cognitive deficits associated with dementias. These drugs act by a variety of mechanisms. (See all compounds classified as Nootropic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cholinesterase Inhibitors [MoA]; Cholinesterase Inhibitor [EPC]

    API Reference Price

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DATE - FEB-2025 - RETEST DATE -JAN-2028","address":"B.S.D.MARG, GOVANDI STATION ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"USV PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"SHINPO LIMITED","customerCountry":"KOREA, REPUBLIC OF","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"1600","totalValueFC":"39534.5","currency":"N\/A","unitRateINR":136975.45679999999,"date":"19-Mar-2025","totalValueINR":"3424386.42","totalValueInUsd":"39534.5","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"9149561","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"B.S.D.MARG, GOVANDI STATION ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742581800,"product":"DONEPEZIL HCL MONOHYDRATE FORM 1","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"T.O.CHEMICALS 1979 LTD.","customerCountry":"THAILAND","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"2200","totalValueFC":"43226.1","currency":"USD","unitRateINR":187206.986,"date":"22-Mar-2025","totalValueINR":"3744139.72","totalValueInUsd":"43226.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"9246299","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743100200,"product":"DONEPEZIL HYDROCHLORIDE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES","supplierCountry":"INDIA","foreign_port":"INCHEON INTL APT\/SEO","customer":"HIGHFLY CO. LTD","customerCountry":"KOREA, REPUBLIC OF","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1400","totalValueFC":"68707.2","currency":"USD","unitRateINR":119025.02,"date":"28-Mar-2025","totalValueINR":"5951251","totalValueInUsd":"68707.2","indian_port":"Hyderabad ICD","hs_no":"29339990","bill_no":"9476838","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652898600,"product":"DONEPEZIL HYDROCHLORIDE, LOT NO 12042502 15KG\/DRUM","address":"PLOT NO.135, DR.NO.10-153\/1,","city":"VISAKHAPATNAM, ANDHRA PRADESH","supplier":"EISAI","supplierCountry":"JAPAN","foreign_port":"N\/A","customer":"EISAI","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1107.2","totalValueFC":"16557.1","currency":"USD","unitRateINR":"85308.6","date":"19-May-2022","totalValueINR":"1279629","totalValueInUsd":"16557.1","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29333990","bill_no":"1000767","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"KOISHIKAWA 04-06-2010 JP","customerAddress":"PLOT NO.135, DR.NO.10-153\/1,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666204200,"product":"RE IMPORT. DONEPEZIL HYDROCHLORIDE BATCH NO. DAA1AXA01D. ( VALUE FOR CUSTOMS PURPOSE ONLY. MATERIAL IS RETURN BACK DUE T","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"KOKANDO PHARMACEUTICALS CO. ","supplierCountry":"INDIA","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"30.48","actualQuantity":"30.48","unit":"KGS","unitRateFc":"5000","totalValueFC":"152745.2","currency":"USD","unitRateINR":"412353.1","date":"20-Oct-2022","totalValueINR":"12568521.35","totalValueInUsd":"152745.2","indian_port":"AHMEDABAD AIR","hs_no":"29333200","bill_no":"2962862","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706121000,"product":"DONEPEZIL HYDROCHLORIDE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"ACTAVIS INC","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"NEULAND LABORATORIES","customerCountry":"INDIA","quantity":"9.30","actualQuantity":"9.3","unit":"KGS","unitRateFc":"1100","totalValueFC":"10351.6","currency":"USD","unitRateINR":"92510","date":"25-Jan-2024","totalValueINR":"860343","totalValueInUsd":"10351.6","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"9835689","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"... MT","customerAddress":"SANALI INFO PARK, A BLOCK"}]
    04-Jan-2021
    28-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 20690

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 20690

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21720

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

    USFDA APPLICATION NUMBER - 21720

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    DOSAGE - TABLET;ORAL - 23MG

    USFDA APPLICATION NUMBER - 22568

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    ABOUT THIS PAGE

    Looking for 120011-70-3 / Donepezil API manufacturers, exporters & distributors?

    Donepezil manufacturers, exporters & distributors 1

    84

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

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

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

    API | Excipient name

    Donepezil

    Synonyms

    120011-70-3, Donepezil hcl, Aricept, Bnag, 110119-84-1, 2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one hydrochloride

    Cas Number

    120011-70-3

    Unique Ingredient Identifier (UNII)

    3O2T2PJ89D

    About Donepezil

    An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.

    Donepezil Hydrochloride Manufacturers

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

    Donepezil Hydrochloride Suppliers

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

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

    Donepezil Hydrochloride USDMF

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

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

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

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

    Donepezil Hydrochloride KDMF

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

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

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

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

    Donepezil Hydrochloride CEP

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

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

    Donepezil Hydrochloride WC

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

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

    Donepezil Hydrochloride 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 Donepezil Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Donepezil Hydrochloride GMP

    Donepezil Hydrochloride 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 Donepezil Hydrochloride 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 Donepezil Hydrochloride GMP manufacturer or Donepezil Hydrochloride GMP API supplier for your needs.

    Donepezil Hydrochloride CoA

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

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

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