Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
API SUPPLIERS
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-27
DMF Number : 17779
Submission : 2004-10-26
Status : Active
Type : II
NDC Package Code : 55111-074
Start Marketing Date : 2004-10-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-04-26
Registration Number : 20130409-158-I-79-13(1)
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Plot No. 9/A, Phase-III, IDA Jeedimetla, Ranga Reddy District, Andhra Pradesh
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Jai Radhe Sales is your partner for all your sourcing needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 21132
Submission : 2007-12-11
Status : Active
Type : II
Certificate Number : CEP 2019-311 - Rev 01
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 3067
Status : Valid
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-1026
Start Marketing Date : 2020-10-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Terrazen ITEX Co., Ltd.
Registration Date : 2019-11-22
Registration Number : 20141008-158-I-439-23(11)
Manufacturer Name : Neuland Laboratories Ltd.
Manufacturer Address : Unit-I, Sy. No: 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District - 502 313, Telangana State, India
| Available Reg Filing : ASMF |
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Minbiotech
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Capital Farma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Solubilizers
Direct Compression
Granulation
Taste Masking
Topical
Lubricants & Glidants
Parenteral
Co-Processed Excipients
Film Formers & Plasticizers
Chewable & Orodispersible Aids
Rheology Modifiers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Surfactant & Foaming Agents
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
US Patents
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
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 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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
