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1. 1 Aminoadamantane
2. 1-aminoadamantane
3. Adamantylamine
4. Adekin
5. Al, Amantadin
6. Aman
7. Amanta
8. Amanta Hci Azu
9. Amanta-hci-azu
10. Amantadin Al
11. Amantadin Azu
12. Amantadin Neuraxpharm
13. Amantadin Ratiopharm
14. Amantadin Stada
15. Amantadin-neuraxpharm
16. Amantadin-ratiopharm
17. Amantadina Juventus
18. Amantadina Llorente
19. Amantadine
20. Amantadinneuraxpharm
21. Amantadinratiopharm
22. Amantahciazu
23. Amixx
24. Azu, Amantadin
25. Cerebramed
26. Endantadine
27. Gen Amantadine
28. Gen-amantadine
29. Genamantadine
30. Hydrochloride, Amantadine
31. Infecto Flu
32. Infecto-flu
33. Infectoflu
34. Infex
35. Juventus, Amantadina
36. Llorente, Amantadina
37. Mantadix
38. Midantan
39. Pms Amantadine
40. Pms-amantadine
41. Pmsamantadine
42. Stada, Amantadin
43. Symadine
44. Symmetrel
45. Tregor
46. Viregyt
47. Wiregyt
1. 665-66-7
2. 1-adamantanamine Hydrochloride
3. Amantadine Hcl
4. Symmetrel
5. 1-aminoadamantane Hydrochloride
6. Adamantan-1-amine Hydrochloride
7. 1-adamantylamine Hydrochloride
8. Adamantanamine Hydrochloride
9. Amazolon
10. Midantan
11. Midantane
12. Mydantane
13. Virofral
14. Symadine
15. Influenol
16. Mantadix
17. Trivaline
18. Amantan
19. Virasol
20. Viregyt
21. Virosol
22. Amantadine (hydrochloride)
23. 1-adamantanamine, Hydrochloride
24. Adamantylamine Hydrochloride
25. Aminoadamantane Hydrochloride
26. Adamantine Hydrochloride
27. Exp-105-1
28. 1-adamantanamine Hcl
29. Exp 105-1
30. Nsc 83653
31. Osmolex
32. Mfcd00074723
33. Nsc-83653
34. Adamantan-1-amine;hydrochloride
35. Mls000028731
36. Gp 38026
37. Tricyclo[3.3.1.13,7]decan-1-amine, Hydrochloride
38. M6q1eo9td0
39. Ads-5102
40. Amantadine Hydrochloride (symmetrel)
41. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, Hydrochloride
42. Smr000059204
43. 665-66-7 (hcl)
44. Tricyclo(3.3.1.13,7)decan-1-amine, Hydrochloride
45. Adamantan-1-aminium Chloride
46. Chebi:2619
47. 1-adamantanamine Hydrochloride;1-adamantylamine Hydrochloride;1-aminoadamantane Hydrochloride
48. 1-adamantanaminehydrochloride
49. 1-aminoadamantene Hydrochloride
50. Nsc83653
51. Einecs 211-560-2
52. Unii-m6q1eo9td0
53. Cerebramed
54. Adamine
55. Hofcomant
56. Lysovir
57. Mantadan
58. Mantadine
59. Nurelin
60. Adamin
61. Ai3-52211
62. Sr-01000075353
63. Symmetrel (tn)
64. Osmolex Er (tn)
65. Gocovri (tn)
66. Amantadinehydrochloride
67. Amantadine Hydrochloride [usan:usp:jan]
68. Opera_id_671
69. Adamantamine Hydrochloride
70. Ec 211-560-2
71. Adamantyl Amine Hydrochloride
72. 1-adamantanamin Hydrochlorid
73. C10h17n.hcl
74. Chembl1569
75. Schembl40713
76. Adamantan-1-aminehydrochloride
77. Mls002153257
78. Mls003899199
79. Spectrum1500110
80. Hy-b0402a
81. 1-aminoada- Mantane Hydrochloride
82. Amy3568
83. Dtxsid50874031
84. N04bb01
85. Hms1920a19
86. Pharmakon1600-01500110
87. Ads-5101
88. Bcp11857
89. Str01017
90. Tox21_500004
91. A3a501
92. Amantadine Hydrochloride [mi]
93. Ccg-38899
94. Nsc755860
95. S2451
96. Tricyclo[3.3.1.13, Hydrochloride
97. Amantadine Hydrochloride (jp17/usp)
98. Amantadine Hydrochloride [jan]
99. Akos015900347
100. Akos015951188
101. Ac-8689
102. Amantadine Hydrochloride [usan]
103. Lp00004
104. Nc00489
105. Nsc-755860
106. Amantadine Hydrochloride [mart.]
107. Amantadine Hydrochloride [vandf]
108. 1-adamantylammonium;1-adamantanamine Hcl
109. Amantadine Hydrochloride [usp-rs]
110. Amantadine Hydrochloride [who-dd]
111. Ncgc00093531-01
112. Ncgc00093531-02
113. Ncgc00093531-03
114. Ncgc00093531-04
115. Ncgc00260689-01
116. Ba166177
117. Smr001370746
118. A0588
119. Eu-0100004
120. Ft-0622248
121. Sw219892-1
122. (3r,5s,7s)-adamantan-1-amine Hydrochloride
123. Amantadine Hydrochloride [orange Book]
124. A 1260
125. Amantadine Hydrochloride [ep Monograph]
126. Amantadine Hydrochloride [usp Monograph]
127. C07939
128. D00777
129. F15409
130. Wln: L66 B6 A B- C 1b Itj Bz &gh
131. A835493
132. Amantadine Hydrochlorid 100 Microg/ml In Methanol
133. Amantadine Hydrochloride 1000 Microg/ml In Methanol
134. J-650095
135. J-650235
136. Q-200621
137. Sr-01000075353-1
138. Tricyclo[3.3.1.1 3,7]decan-1-amine Hydrochloride
139. Tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride
140. Q27105739
141. F3111-1111
142. Tricyclo(3.3.1.13,7)decan-1-amine, Hydrochloride (1:1)
143. Amantadine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
144. Amantadine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
145. Amantadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
146. 1-aminoadamantane Hydrochloride; 1-adamantanamine Hydrochloride; 1-adamantylamine Hydrochloride
| Molecular Weight | 187.71 g/mol |
|---|---|
| Molecular Formula | C10H18ClN |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 187.1127773 g/mol |
| Monoisotopic Mass | 187.1127773 g/mol |
| Topological Polar Surface Area | 26 Ų |
| Heavy Atom Count | 12 |
| Formal Charge | 0 |
| Complexity | 144 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Amantadine hydrochloride |
| Drug Label | Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in... |
| Active Ingredient | Amantadine hydrochloride |
| Dosage Form | Tablet; Syrup; Capsule |
| Route | Oral |
| Strength | 100mg; 50mg/5ml |
| Market Status | Prescription |
| Company | Wockhardt; Silarx; Hi Tech Pharma; Carolina Medcl; Pharm Assoc; Vintage; Usl Pharma; Banner Pharmacaps; Sandoz; Mikart |
| 2 of 2 | |
|---|---|
| Drug Name | Amantadine hydrochloride |
| Drug Label | Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in... |
| Active Ingredient | Amantadine hydrochloride |
| Dosage Form | Tablet; Syrup; Capsule |
| Route | Oral |
| Strength | 100mg; 50mg/5ml |
| Market Status | Prescription |
| Company | Wockhardt; Silarx; Hi Tech Pharma; Carolina Medcl; Pharm Assoc; Vintage; Usl Pharma; Banner Pharmacaps; Sandoz; Mikart |
Treatment of Parkinson's disease and parkinsonism
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.)
Antiviral Agents
Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)
Analgesics, Non-Narcotic
A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)
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.)
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-16
Pay. Date : 2014-05-13
DMF Number : 6924
Submission : 1987-04-08
Status : Active
Type : II
Certificate Number : R1-CEP 2000-014 - Rev 08
Issue Date : 2023-05-25
Type : Chemical
Substance Number : 463
Status : Valid
NDC Package Code : 52932-0707
Start Marketing Date : 2009-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-20
Pay. Date : 2012-11-27
DMF Number : 23528
Submission : 2010-02-11
Status : Active
Type : II
Certificate Number : CEP 2017-284 - Rev 03
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 463
Status : Valid
NDC Package Code : 63818-0435
Start Marketing Date : 2016-05-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
| Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-04
Pay. Date : 2015-04-28
DMF Number : 25151
Submission : 2011-07-21
Status : Active
Type : II
Registration Number : 223MF10070
Registrant's Address : 333, Jiangnan Road, Hengdian, Dongyang, Zhejiang, 322118, China.
Initial Date of Registration : 2011-05-27
Latest Date of Registration : --
NDC Package Code : 66653-003
Start Marketing Date : 2016-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29486
Submission : 2015-09-01
Status : Active
Type : II
NDC Package Code : 17373-1446
Start Marketing Date : 2014-10-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9665
Submission : 1992-04-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2817
Submission : 1977-01-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3739
Submission : 1980-02-21
Status : Inactive
Type : II
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Average Price (USD/KGS) |
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 129MG BASE
USFDA APPLICATION NUMBER - 209410
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 161MG BASE
USFDA APPLICATION NUMBER - 209410
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 193MG BASE
USFDA APPLICATION NUMBER - 209410
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 258MG BASE
USFDA APPLICATION NUMBER - 209410
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ABOUT THIS PAGE
A Amantadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine Hydrochloride, including repackagers and relabelers. The FDA regulates Amantadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine 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 Amantadine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amantadine Hydrochloride supplier is an individual or a company that provides Amantadine Hydrochloride active pharmaceutical ingredient (API) or Amantadine Hydrochloride finished formulations upon request. The Amantadine Hydrochloride suppliers may include Amantadine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Amantadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amantadine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Amantadine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Amantadine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Amantadine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amantadine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Amantadine Hydrochloride USDMF includes data on Amantadine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amantadine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amantadine 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 Amantadine Hydrochloride Drug Master File in Japan (Amantadine Hydrochloride JDMF) empowers Amantadine 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 Amantadine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Amantadine 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 Amantadine Hydrochloride suppliers with JDMF on PharmaCompass.
A Amantadine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Amantadine Hydrochloride Certificate of Suitability (COS). The purpose of a Amantadine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amantadine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amantadine Hydrochloride to their clients by showing that a Amantadine Hydrochloride CEP has been issued for it. The manufacturer submits a Amantadine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amantadine Hydrochloride CEP holder for the record. Additionally, the data presented in the Amantadine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amantadine Hydrochloride DMF.
A Amantadine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amantadine 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 Amantadine Hydrochloride suppliers with CEP (COS) 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 Amantadine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amantadine 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 Amantadine 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 Amantadine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amantadine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amantadine Hydrochloride suppliers with NDC on PharmaCompass.
Amantadine 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 Amantadine 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 Amantadine Hydrochloride GMP manufacturer or Amantadine Hydrochloride GMP API supplier for your needs.
A Amantadine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Amantadine Hydrochloride's compliance with Amantadine Hydrochloride specifications and serves as a tool for batch-level quality control.
Amantadine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Amantadine 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.
Amantadine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Amantadine Hydrochloride EP), Amantadine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amantadine Hydrochloride USP).
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