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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]

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CHANDIGARH,? 160002, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749407400,"product":"DONEPEZIL HYDROCHLORIDE MONOHYDRATE USP","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"UNDISCLOSED","customerCountry":"ALGERIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1450","totalValueFC":"14057.9","currency":"USD","unitRateINR":120793.2,"date":"09-Jun-2025","totalValueINR":"1207932","totalValueInUsd":"14057.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2541856","productDescription":"API","marketType":"","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749580200,"product":"DONEPEZIL HYDROCHLORIDE ANHYDROUS USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"PTNOVELL PHARMACEUTICAL LABORATORI","customerCountry":"INDONESIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"1300","totalValueFC":"4932.6","currency":"USD","unitRateINR":105958.5,"date":"11-Jun-2025","totalValueINR":"423834","totalValueInUsd":"4932.6","indian_port":"Hyderabad Air","hs_no":"29093090","bill_no":"2622267","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749580200,"product":"DONEPEZIL HCL","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"UNDISCLOSED","customerCountry":"GREECE","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1500","totalValueFC":"7164.9","currency":"USD","unitRateINR":123129,"date":"11-Jun-2025","totalValueINR":"615645","totalValueInUsd":"7164.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2625143","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749666600,"product":"PHARMACEUTICAL RAW MATERIALDONEPEZIL HYDROCHLORIDE USP","address":"NO.15, GOPALA KRISHNA ROAD,","city":"CHENNAI \/ T.N.","supplier":"LLOYD LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"INCHEON","customer":"TO ORDER OF CONSIGNEE OF CONSIGNEES","customerCountry":"KOREA, REPUBLIC OF","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1650","totalValueFC":"23661.5","currency":"USD","unitRateINR":135541.35000000001,"date":"12-Jun-2025","totalValueINR":"2033120.25","totalValueInUsd":"23661.5","indian_port":"JM FTZ SEZ\/MANNUR","hs_no":"29339990","bill_no":"2650584","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"JM FTZ SEZ\/MANNUR","supplierAddress":"NO.15, GOPALA KRISHNA ROAD,, CHENNAI \/ T.N.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750098600,"product":"DONEPEZIL HYDROCHLORIDE USP","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"BUSAN","customer":"UNDISCLOSED","customerCountry":"KOREA, REPUBLIC OF","quantity":"34.00","actualQuantity":"34","unit":"KGS","unitRateFc":"1450","totalValueFC":"48522.2","currency":"USD","unitRateINR":122626.23529411765,"date":"17-Jun-2025","totalValueINR":"4169292","totalValueInUsd":"48522.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2776848","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750185000,"product":"DONEPEZIL HYDROCHLORIDE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"SHANGHAI - 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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685298600,"product":"DONEPEZIL HYDROCHLORIDE","address":"PLOT NO.135, DR.NO.10-153\/1,","city":"VISAKHAPATNAM, ANDHRA PRADESH","supplier":"XXSAIXXOXXTD","supplierCountry":"JAPAN","foreign_port":"N\/A","customer":"EISAI PHARMACEUTICALS INDIA PVT LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1001.3","totalValueFC":"15204.6","currency":"USD","unitRateINR":"83406.8","date":"29-May-2023","totalValueINR":"1251102","totalValueInUsd":"15204.6","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29333990","bill_no":"1000839","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.135, DR.NO.10-153\/1,"}]
04-Jan-2022
30-Jun-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

63

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 HCl Manufacturers

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

Donepezil HCl Suppliers

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

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

Donepezil HCl USDMF

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

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

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

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

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

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

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

Donepezil HCl CEP

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

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

Donepezil HCl WC

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

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

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

Finished drug products

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

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

Donepezil HCl GMP

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

Donepezil HCl CoA

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

Donepezil HCl CoA mostly includes findings from lab analyses of a specific batch. For each Donepezil HCl 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 HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Donepezil HCl EP), Donepezil HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Donepezil HCl 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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