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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
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-
| Molecular Weight | 416.0 g/mol |
|---|---|
| Molecular Formula | C24H30ClNO3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 6 |
| Exact Mass | 415.1914215 g/mol |
| Monoisotopic Mass | 415.1914215 g/mol |
| Topological Polar Surface Area | 38.8 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 510 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Aricept |
| PubMed Health | Donepezil (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | ARICEPT (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 Ingredient | Donepezil hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 23mg; 10mg |
| Market Status | Prescription |
| Company | Eisai |
| 2 of 4 | |
|---|---|
| Drug Name | Donepezil hydrochloride |
| Drug Label | 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 commonly refe... |
| Active Ingredient | Donepezil hydrochloride |
| Dosage Form | Tablet, orally disintegrating; Tablet |
| Route | oral; Oral |
| Strength | 5mg; 23mg; 10mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; 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 Name | Aricept |
| PubMed Health | Donepezil (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | ARICEPT (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 Ingredient | Donepezil hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 23mg; 10mg |
| Market Status | Prescription |
| Company | Eisai |
| 4 of 4 | |
|---|---|
| Drug Name | Donepezil hydrochloride |
| Drug Label | 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 commonly refe... |
| Active Ingredient | Donepezil hydrochloride |
| Dosage Form | Tablet, orally disintegrating; Tablet |
| Route | oral; Oral |
| Strength | 5mg; 23mg; 10mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; 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 |
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.)
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Donepezil Hydrochloride Monohydrate, Monohydrate
Certificate Number : CEP 2022-079 - Rev 01
Status : Valid
Issue Date : 2023-12-18
Type : Chemical
Substance Number : 3067
Donepezil Hydrochloride Monohydrate, Monohydrate
Certificate Number : CEP 2020-132 - Rev 01
Status : Valid
Issue Date : 2023-12-15
Type : Chemical
Substance Number : 3067
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2022-301 - Rev 02
Status : Valid
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2022-304 - Rev 00
Status : Valid
Issue Date : 2024-03-15
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2021-494 - Rev 00
Status : Valid
Issue Date : 2024-02-22
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2022-008 - Rev 00
Status : Valid
Issue Date : 2024-06-05
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2021-116 - Rev 03
Status : Valid
Issue Date : 2025-01-23
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2023-061 - Rev 01
Status : Valid
Issue Date : 2024-11-05
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride, Monohydrate
Certificate Number : CEP 2022-407 - Rev 01
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 2582
Donepezil Hydrochloride Monohydrate, Monohydrate
Certificate Number : CEP 2020-244 - Rev 02
Status : Valid
Issue Date : 2023-12-15
Type : Chemical
Substance Number : 3067
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 222MF10202
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2010-07-14
Latest Date of Registration : 2010-07-14
Registration Number : 227MF10005
Registrant's Address : Village-Bhagwanpur, Barwala Road, Derabassi-140 507 District-S. A. S. Nagar (Mohali)P...
Initial Date of Registration : 2015-01-05
Latest Date of Registration : 2015-01-05
Registration Number : 222MF10189
Registrant's Address : 1A, Sector 16A, Noida 201 301, Uttar Pradesh, India
Initial Date of Registration : 2010-07-06
Latest Date of Registration : 2010-07-06
Registration Number : 303MF10149
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2021-09-17
Latest Date of Registration : 2021-09-17
Registration Number : 307MF10005
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2025-01-09
Latest Date of Registration : 2025-01-09
Donepezil Hydrochloride "Teva"
Registration Number : 222MF10184
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2010-06-28
Latest Date of Registration : 2018-11-28
Registration Number : 230MF10046
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2018-03-27
Latest Date of Registration : 2021-04-15
Registration Number : 227MF10288
Registrant's Address : 78/A,Vengalrao Nagar,Hyderabad-500 038,Telangana,INDIA
Initial Date of Registration : 2015-12-15
Latest Date of Registration : 2025-05-27
Registration Number : 302MF10149
Registrant's Address : No. 268 Tianrun Road, Wendeng Economic Development Zone, Weihai, Shandong, China
Initial Date of Registration : 2020-12-15
Latest Date of Registration : 2020-12-15
Registration Number : 222MF10156
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2010-05-17
Latest Date of Registration : 2021-12-15
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Drugs in Development
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Regulatory Info : RX
Registration Country : USA
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;14MG
Packaging :
Approval Date : 2014-12-23
Application Number : 206439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;28MG
Packaging :
Approval Date : 2014-12-23
Application Number : 206439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;7MG
Packaging :
Approval Date : 2016-07-18
Application Number : 206439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;21MG
Packaging :
Approval Date : 2016-07-18
Application Number : 206439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Arimentia 5mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Arimentia 10mg
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Donepezil
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Donepezil
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Immediate Release Pellet
Dosage Strength : 11.11%
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Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 23MG
Packaging :
Approval Date : 2013-07-24
Application Number : 202723
Regulatory Info : RX
Registration Country : USA
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RLD : Yes
TE Code : AB
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;14MG
Approval Date : 2014-12-23
Application Number : 206439
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;28MG
Approval Date : 2014-12-23
Application Number : 206439
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;7MG
Approval Date : 2016-07-18
Application Number : 206439
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Brand Name : NAMZARIC
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG;21MG
Approval Date : 2016-07-18
Application Number : 206439
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 23MG
Approval Date : 2013-07-24
Application Number : 202723
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
RLD : No
TE Code : AB
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2011-05-31
Application Number : 78662
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
RLD : No
TE Code : AB
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2011-05-31
Application Number : 78662
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2012-06-13
Application Number : 201634
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 23MG
Approval Date : 2015-10-30
Application Number : 202782
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Donepezilo Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-16
Application Number : 69891
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Donepezilo Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-16
Application Number : 69892
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Donepezilo Thinks Pharma
Dosage Form : Orodispersible Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2012-08-02
Application Number : 76298
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Norway
Brand Name : Donepezil Accord
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Yasn
Dosage Form : Donepezil 5Mg 28 Combined Oral Use
Dosage Strength : 28 orodispers CPR 5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : United Kingdom
Brand Name :
Dosage Form : OD TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : United Kingdom
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pezimax
Dosage Form : Oral Solution
Dosage Strength : 2MG
Packaging :
Approval Date : 2019-12-26
Application Number : 84747
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Brand Name : Donepezil
Dosage Form : Donepezil 5Mg 28 Combined Oral Use
Dosage Strength : 28 cpr riv 5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 20690
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20690
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG
USFDA APPLICATION NUMBER - 21720
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG
USFDA APPLICATION NUMBER - 21720
DOSAGE - TABLET;ORAL - 23MG
USFDA APPLICATION NUMBER - 22568
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8580858
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code : U-1641
Delist Requested :
Patent Use Description : MEMANTINE HCL/DONEPEZI...
Patent Expiration Date : 2025-11-22
Patent Expiration Date : 2026-05-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8283379*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-05-22
Patent Expiration Date : 2026-05-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8329752*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-05-22
Patent Expiration Date : 2029-12-05
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8058291
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code : U-1641
Delist Requested :
Patent Use Description : MEMANTINE HCL/DONEPEZI...
Patent Expiration Date : 2029-12-05
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8338486
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code : U-1641
Delist Requested :
Patent Use Description : MEMANTINE HCL/DONEPEZI...
Patent Expiration Date : 2025-11-22
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8293794
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 206439
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-11-22
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8173708
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code : U-1641
Delist Requested : Y
Patent Use Description : MEMANTINE HCL/DONEPEZI...
Patent Expiration Date : 2025-11-22
Patent Expiration Date : 2026-05-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8598233*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-05-22
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8338486
Drug Substance Claim :
Drug Product Claim :
Application Number : 206439
Patent Use Code : U-1641
Delist Requested :
Patent Use Description : MEMANTINE HCL/DONEPEZI...
Patent Expiration Date : 2025-11-22
Patent Expiration Date : 2025-11-22
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US Patent Number : 8598233
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 206439
Patent Use Code :
Delist Requested : Y
Patent Use Description :
Patent Expiration Date : 2025-11-22
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]US Exclusivities
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Exclusivity Code : PC
Exclusivity Expiration Date : 2025-07-15
Application Number : 208328
Product Number : 1
Exclusivity Details :
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Exclusivity Code : PC
Exclusivity Expiration Date : 2025-07-15
Application Number : 208328
Product Number : 2
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2025-03-11
Application Number : 212304
Product Number : 1
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2025-03-11
Application Number : 212304
Product Number : 2
Exclusivity Details :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Health Canada Patents
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Brand Name : ARICEPT
Patent Number : 2252806
Filing Date : 1997-06-06
Strength per Unit : 5 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Brand Name : ARICEPT
Patent Number : 2252806
Filing Date : 1997-06-06
Strength per Unit : 10 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Brand Name : ARICEPT RDT
Patent Number : 2252806
Filing Date : 1997-06-06
Strength per Unit : 5 mg
Dosage Form : Rapidly Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Brand Name : ARICEPT RDT
Patent Number : 1338808
Filing Date : 1988-06-21
Strength per Unit : 5 mg
Dosage Form : Rapidly Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Brand Name : ARICEPT RDT
Patent Number : 2252806
Filing Date : 1997-06-06
Strength per Unit : 10 mg
Dosage Form : Rapidly Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2017-06-06
Date Granted : 2005-11-22
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Brand Name : ARICEPT RDT
Patent Number : 1338808
Filing Date : 1988-06-21
Strength per Unit : 10 mg
Dosage Form : Rapidly Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Brand Name : ARICEPT
Patent Number : 1338808
Filing Date : 1988-06-21
Strength per Unit : 5 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
Brand Name : ARICEPT
Patent Number : 1338808
Filing Date : 1988-06-21
Strength per Unit : 10 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-12-24
Date Granted : 1996-12-24
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Analytical Methods
Product Code : AA30S05-1546WT
Classification : DrugsC Metabolites
Product Characteristics : F140312A
Category :
Description :
Product Code : KSB99S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F140707A
Category :
Description :
Product Code : KCN99S05-2546WT
Classification : Optical isomers
Product Characteristics : F131114B
Category :
Description :
Product Code : TA12S05-1546WT
Classification : DrugsC Metabolites
Product Characteristics : F131227C
Category :
Description :
Product Code : KSB99S05-2546WT
Classification : Optical isomers
Product Characteristics : F140707A
Category :
Description :
Product Code : TA12S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F131216A
Category :
Description :
Product Code : AA30S05-1546WT
Classification : DrugsC Metabolites
Product Characteristics : F140228D
Category :
Description :
Product Code : KCN99S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F131114B
Category :
Description :
Product Code : AA30S05-1546WT
Classification : DrugsC Metabolites
Product Characteristics : F140228A
Category :
Description :
ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
