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1. 1,3-dimethyl-5-aminoadamantane
2. 1-amino-3,5-dimethyladamantane
3. Axura
4. D 145
5. D-145
6. D145
7. Ebixa
8. Memantin
9. Memantine
10. Namenda
1. 41100-52-1
2. Memantine Hcl
3. Namenda
4. 3,5-dimethyl-1-adamantanamine Hydrochloride
5. 3,5-dimethyladamantan-1-amine Hydrochloride
6. Akatinol
7. Axura
8. Namenda Xr
9. Memary
10. Ebixa
11. Memantine Mylan
12. 1-amino-3,5-dimethyladamantane Hydrochloride
13. Memantine Merz
14. Memantine.hcl
15. Memantine Accord
16. Memantine Lek
17. Memantine (hydrochloride)
18. Acrescent
19. Balaxur
20. Auxura
21. Unii-jy0wd0ua60
22. 3,5-dimethyladamantan-1-amine;hydrochloride
23. Jy0wd0ua60
24. Mfcd00214336
25. Memantine Ratiopharm
26. Memantine Hydrochloride [usan]
27. Chebi:64323
28. Sun-y7017
29. Nsc-102290
30. 3,5-dimethyladamantan-1-aminium Chloride
31. D-145
32. Mls001332605
33. 3,5-dimethyl-1-aminoadamantane Hydrochloride
34. (3,5-dimethyl-1-adamantyl)amine Hydrochloride
35. 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine Hydrochloride
36. Fp-01
37. 1,3-dimethyl-5-adamantanamine Hcl
38. 3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine Hydrochloride
39. 41100-52-1 (hcl)
40. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride
41. D 145
42. Mantine
43. Ebixza
44. 3,5-dimethyl-tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride
45. 3,5-dimethyltricyclo(3.3.1.13,7)decan-1-amine Hydrochloride
46. 3,5-dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine Hydrochloride
47. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride
48. 3,5-dimethyl-1-adamantylamine
49. 3,5-dimethyl-1-aminoadamantane
50. Smr000875213
51. Sr-01000075458
52. Sun Y7017
53. Einecs 255-219-6
54. Namenda (tn)
55. Memary (tn)
56. Marixino
57. Nsc 102290
58. D-145 (hydrochloride)
59. Schembl3053
60. C12h21n.hcl
61. Chembl1699
62. Mls001332606
63. Spectrum1501121
64. Hy-b0365a
65. Dtxsid90961439
66. Memantine Hydrochloride (namenda)
67. N06dx01
68. Nmi-131
69. Hms1571c17
70. Hms1921h03
71. Pharmakon1600-01501121
72. Memantine Hydrochloride (jan/usp)
73. Memantine Hydrochloride [mi]
74. Tox21_500861
75. Ac-559
76. Ccg-39018
77. Memantine Hydrochloride [jan]
78. Mrz-2/145
79. Nsc102290
80. Nsc757843
81. S2043
82. Akos015889460
83. Bcp9000253
84. Lp00861
85. Memantine Hydrochloride [mart.]
86. Nc00680
87. Memantine Hydrochloride [usp-rs]
88. Memantine Hydrochloride [who-dd]
89. Ncgc00094186-01
90. Ncgc00094186-02
91. Ncgc00094186-03
92. Ncgc00261546-01
93. As-13331
94. Bm164662
95. Memantine Hydrochloride [ema Epar]
96. Sy057917
97. 3,5-dimethyladamantan-1-aminehydrochloride
98. Am20070534
99. D3608
100. Eu-0100861
101. Ft-0650723
102. M-145
103. Memantine Hydrochloride [orange Book]
104. Sw060653-4
105. 1-amino-3,5-dimethyl-adamantane Hydrochloride
106. 3,5-dimethyladamantan-1-amine Hy-drochloride
107. 3,5-dimethyladamantan-1-amine;hydrochloride.
108. D04905
109. M 9292
110. Memantine Hydrochloride [usp Monograph]
111. Namzaric Component Memantine Hydrochloride
112. Memantine Hydrochloride Component Of Namzaric
113. Sr-01000075458-1
114. Sr-01000075458-3
115. Sr-01000075458-8
116. Q27133218
117. Z1551429722
118. Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride
119. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride (1:1) (ca Index Name)
120. 1-amino-3,5-dimethyladamantane . Hcl 3,5-dimethyl-1-aminoadamantane . Hcl Memantine . Hydrochloride
| Molecular Weight | 215.76 g/mol |
|---|---|
| Molecular Formula | C12H22ClN |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 215.1440774 g/mol |
| Monoisotopic Mass | 215.1440774 g/mol |
| Topological Polar Surface Area | 26 Ų |
| Heavy Atom Count | 14 |
| Formal Charge | 0 |
| Complexity | 240 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 6 | |
|---|---|
| Drug Name | Memantine hydrochloride |
| PubMed Health | Memantine (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 5mg; 10mg |
| Market Status | Tentative Approval |
| Company | Amneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life |
| 2 of 6 | |
|---|---|
| Drug Name | Namenda |
| PubMed Health | Memantine (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | 2mg/ml; 5mg; 10mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 3 of 6 | |
|---|---|
| Drug Name | Namenda xr |
| Drug Label | NAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 7mg; 14mg; 21mg; 28mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 4 of 6 | |
|---|---|
| Drug Name | Memantine hydrochloride |
| PubMed Health | Memantine (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 5mg; 10mg |
| Market Status | Tentative Approval |
| Company | Amneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life |
| 5 of 6 | |
|---|---|
| Drug Name | Namenda |
| PubMed Health | Memantine (By mouth) |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | 2mg/ml; 5mg; 10mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 6 of 6 | |
|---|---|
| Drug Name | Namenda xr |
| Drug Label | NAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei... |
| Active Ingredient | Memantine hydrochloride |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 7mg; 14mg; 21mg; 28mg |
| Market Status | Prescription |
| Company | Forest Labs |
Treatment of patients with moderate to severe Alzheimer's disease.
Treatment of patients with moderate to severe Alzheimers disease.
Treatment of patients with moderate to severe Alzheimers disease.
Treatment of patients with moderate to severe Alzheimers disease.
Treatment of patients with moderate to severe Alzheimer's disease.
Treatment of patients with moderate to severe Alzheimers disease
Treatment of patients with moderate to severe Alzheimers disease.
Treatment of patients with moderate to severe Alzheimers disease.
Treatment of Alzheimers disease
Antiparkinson Agents
Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)
Dopamine Agents
Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)
Excitatory Amino Acid Antagonists
Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)
N06DX01
N06DX01
N06DX01
N06DX01
N06DX01
N06DX01
N06DX01
N06DX01
N06D
N06DA52
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Memantine Hydrochloride, Form-I
Certificate Number : CEP 2025-110 - Rev 00
Status : Valid
Issue Date : 2026-02-04
Type : Chemical
Substance Number : 2773
Memantine Hydrochloride, Crystalline Form-I, Mic...
Certificate Number : CEP 2025-237 - Rev 00
Status : Valid
Issue Date : 2025-11-24
Type : Chemical
Substance Number : 2773
Certificate Number : CEP 2025-311 - Rev 00
Status : Valid
Issue Date : 2026-01-23
Type : Chemical
Substance Number : 2773
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Date of Issue : 2025-08-08
Valid Till : 2028-07-02
Written Confirmation Number : WC-0081
Address of the Firm : API Division Panelav, At & Post. - Panelav, Tal.
Date of Issue : 2022-09-30
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...
Date of Issue : 2022-06-14
Valid Till : 2025-07-02
Written Confirmation Number : WC-0094nA2A
Address of the Firm : Plot No. 72 & 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bengaluru-560 1...
Memantine Hydrochloride IH/USP/EP
Date of Issue : 2025-10-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0087
Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & Kl201, Village Lakhmapur, Taluka Dindo...
Date of Issue : 2025-09-08
Valid Till : 2028-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 182 to 186, 192-A and 193 to 197 & 212/A,B,C,D Phase-ll, IDA, Pashamyla...
Date of Issue : 2022-12-30
Valid Till : 2026-01-05
Written Confirmation Number : WC-0384
Address of the Firm : UNIT-IV, Sy No. 332, 333 & 335 Veliminedu (Village), Chityal (Mandal), Nalgonda ...
Date of Issue : 2022-11-08
Valid Till : 2025-02-07
Written Confirmation Number : WC-0153
Address of the Firm : Plot No. L-6, MIDC Taloja, Tal.Panvel, District-Raigad-41 0208, Maharashtra, Ind...
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159nA2
Address of the Firm : A-7/A-8, M.I.D.C Industrial Area, Ahmednagar-414111, Maharashtra, India
Memantine Hydrochloride USP/IH
Date of Issue : 2025-09-19
Valid Till : 2028-07-27
Written Confirmation Number : WC-0062
Address of the Firm : Plot No. 197, Sector -I, Pithampur -454775, District -Dhar (MP), India.
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
CAS Number : 702-79-4
End Use API : Memantine Hydrochloride
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Chloro-3,5-dimethyladamantane
CAS Number : 707-36-8
End Use API : Memantine Hydrochloride
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Hydroxy-3,5-dimethyladamantane
CAS Number : 707-37-9
End Use API : Memantine Hydrochloride
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Acetylamido-3,5-dimethyladamantane
CAS Number : 19982-07-1
End Use API : Memantine Hydrochloride
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Suanfarma, at the Core of a Better Life.
CAS Number : 281-23-2
End Use API : Memantine Hydrochloride
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
CAS Number : 702-79-4
End Use API : Memantine Hydrochloride
About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...
1-Bromo-3,5-dimethyladamantane
CAS Number : 941-37-7
End Use API : Memantine Hydrochloride
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...
CAS Number : 702-79-4
End Use API : Memantine Hydrochloride
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...
1,3 -dimethyladamantane
CAS Number : 702-79-4
End Use API : Memantine Hydrochloride
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
1-Bromo-3,5-Dimethyl adamantine
CAS Number : 941-37-7
End Use API : Memantine Hydrochloride
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Memantin Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 22-03-2013
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Memantin Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 22-03-2013
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
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
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 : 15MG
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 : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Memantine \"Lek\"
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 22-04-2013
Application Number : 28105120112
Regulatory Info : Prescription
Registration Country : Denmark
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Memantine \"Lek\"
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 22-04-2013
Application Number : 28105120212
Regulatory Info : Prescription
Registration Country : Denmark
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Memantine Lek
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 22-04-2013
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Memantine Lek
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 22-04-2013
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
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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 - 21487
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22525
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PharmaCompass offers a list of Memantine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Memantine Hydrochloride API Price utilized in the formulation of products. Memantine Hydrochloride API Price is not always fixed or binding as the Memantine Hydrochloride Price is obtained through a variety of data sources. The Memantine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Memantine HCL (2) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine HCL (2), including repackagers and relabelers. The FDA regulates Memantine HCL (2) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine HCL (2) 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 Memantine HCL (2) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine HCL (2) supplier is an individual or a company that provides Memantine HCL (2) active pharmaceutical ingredient (API) or Memantine HCL (2) finished formulations upon request. The Memantine HCL (2) suppliers may include Memantine HCL (2) API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine HCL (2) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine HCL (2) DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine HCL (2) active pharmaceutical ingredient (API) in detail. Different forms of Memantine HCL (2) DMFs exist exist since differing nations have different regulations, such as Memantine HCL (2) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine HCL (2) DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine HCL (2) USDMF includes data on Memantine HCL (2)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine HCL (2) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine HCL (2) 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 Memantine HCL (2) Drug Master File in Japan (Memantine HCL (2) JDMF) empowers Memantine HCL (2) 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 Memantine HCL (2) JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine HCL (2) 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 Memantine HCL (2) 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 Memantine HCL (2) Drug Master File in Korea (Memantine HCL (2) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine HCL (2). The MFDS reviews the Memantine HCL (2) KDMF as part of the drug registration process and uses the information provided in the Memantine HCL (2) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memantine HCL (2) 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 Memantine HCL (2) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memantine HCL (2) suppliers with KDMF on PharmaCompass.
A Memantine HCL (2) CEP of the European Pharmacopoeia monograph is often referred to as a Memantine HCL (2) Certificate of Suitability (COS). The purpose of a Memantine HCL (2) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Memantine HCL (2) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Memantine HCL (2) to their clients by showing that a Memantine HCL (2) CEP has been issued for it. The manufacturer submits a Memantine HCL (2) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Memantine HCL (2) CEP holder for the record. Additionally, the data presented in the Memantine HCL (2) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Memantine HCL (2) DMF.
A Memantine HCL (2) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Memantine HCL (2) 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 Memantine HCL (2) suppliers with CEP (COS) on PharmaCompass.
A Memantine HCL (2) written confirmation (Memantine HCL (2) WC) is an official document issued by a regulatory agency to a Memantine HCL (2) manufacturer, verifying that the manufacturing facility of a Memantine HCL (2) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine HCL (2) APIs or Memantine HCL (2) finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine HCL (2) WC (written confirmation) as part of the regulatory process.
click here to find a list of Memantine HCL (2) 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 Memantine HCL (2) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memantine HCL (2) 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 Memantine HCL (2) 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 Memantine HCL (2) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine HCL (2) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memantine HCL (2) suppliers with NDC on PharmaCompass.
Memantine HCL (2) 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 Memantine HCL (2) 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 Memantine HCL (2) GMP manufacturer or Memantine HCL (2) GMP API supplier for your needs.
A Memantine HCL (2) CoA (Certificate of Analysis) is a formal document that attests to Memantine HCL (2)'s compliance with Memantine HCL (2) specifications and serves as a tool for batch-level quality control.
Memantine HCL (2) CoA mostly includes findings from lab analyses of a specific batch. For each Memantine HCL (2) 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.
Memantine HCL (2) may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine HCL (2) EP), Memantine HCL (2) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine HCL (2) USP).
