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1. Galantamin
2. Galantamine
3. Galanthamine
4. Galanthamine Hydrobromide
5. Lycoremine
6. Nivalin
7. Nivaline
8. Razadyne
9. Reminyl
1. Galanthamine Hydrobromide
2. 1953-04-4
3. Reminyl
4. Nivalin
5. Nivaline
6. Razadyne
7. Lycoremine Hydrobromide
8. Jilkon Hydrobromide
9. Galanthamine (hydrobromide)
10. Galanthamine Hbr
11. Tamilin
12. 193146-85-9
13. Mj4ptd2vvw
14. 5n4sa4kqx9
15. (-)-galantamine Hydrobromide
16. (+/-)-galantamine Hydrobromide
17. (+/-)-galanthamine Hydrobromide
18. Galantamine Hydrobromide (racemic)
19. Galantamine Hydrobromide, (+/-)-
20. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol;hydrobromide
21. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide
22. Razadyne Er
23. Reminyl (tn)
24. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azoniatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol;bromide
25. (4as,6r,8as)-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6h-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol Hydrobromide
26. Galanthaminehydrobromide
27. 1953-04-4 (hbr); 1953-04-4 (free Base).
28. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0^{1,12}.0^{6,17}]heptadeca-6(17),7,9,15-tetraen-14-ol Hydrobromide
29. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol Hydrobromide
30. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide (1:1), (4ar,6s,8ar)-rel-
31. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide (1:1), (4as,6r,8as)-
32. Smr000449267
33. Sr-01000597844
34. Nivaline (pharmaceutical)
35. C17h22brno3
36. Anti-alzheimer
37. Sr-05000001783
38. Nivalin;razadyne
39. Galantamine Hydrobromide [usan]
40. Reminyl Xl
41. Jilcon Hydrobromide
42. Razadyne (tn)
43. Prestwick_236
44. Einecs 217-780-5
45. Galanthamine Hydrobromide From Lycoris Sp.
46. Mfcd00067672
47. Unii-mj4ptd2vvw
48. Unii-5n4sa4kqx9
49. 1953-04-4 Unlabeled
50. Chembl1555
51. Galanthamine-d3 Hydrobromide
52. Mls000758283
53. Mls001401401
54. Galanthamine Hydrobromide,(s)
55. Schembl177993
56. Spectrum1501202
57. Hms1569f18
58. Hms1921p21
59. Hy-a0009
60. Galantamine Hydrobromide (jan/usp)
61. Ac-469
62. Ccg-38829
63. Galantamine Hydrobromide [mi]
64. Galantamine Hydrobromide [usan:usp]
65. S1339
66. Galantamine Hydrobromide [jan]
67. Galanthamine-o-methyl-d3 Hydrobromide
68. Akos007930166
69. Akos015960209
70. Cs-0378
71. Fd10095
72. Galantamine Hydrobromide [hsdb]
73. Nc00061
74. Galantamine Hydrobromide [mart.]
75. Galantamine Hydrobromide [vandf]
76. Galantamine Hydrobromide [usp-rs]
77. Galantamine Hydrobromide [who-dd]
78. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4as,6r,8as)-
79. As-12155
80. Gp-37267
81. G0293
82. Galantamine Hydrobromide [orange Book]
83. D02173
84. Galantamine Hydrobromide [ep Monograph]
85. Galantamine Hydrobromide [usp Monograph]
86. Galantamine Hydrobromide Racemic [usp-rs]
87. 953g044
88. A866857
89. A903748
90. R-113675
91. Sr-01000597844-1
92. Sr-01000597844-5
93. Sr-05000001783-3
94. Q47495772
95. Z1558572528
96. Galanthamine Hydrobromide From Lycoris Sp., >=94% (tlc)
97. (4as,6r,8as)-3-methoxy-11-methyl-5,6,9,10,11,12-hexahydro-4ah-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol Hydrobromide
98. (4as,6r,8as)-3-methoxy-11-methyl-5,6,9,10,11,12-hexahydro-4ah-benzo[2,3]benzofuro[4,3-cd]azepin-6-olhydrobromide
99. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol, Hydrobromide
100. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-d3-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide
101. 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide
102. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hbr (1:1), (4as,6r,8as)-
103. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hbr, (4as,6r,8as)-
104. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4a.alpha.,6.beta.,8ar*)-
105. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4aalpha,6beta,8ar*)-
1. Galantamine
2. Galanthamine Hydrobromide
3. Lycoremin
4. Lycoremine
5. Nivalin
6. Razadyne
7. Reminyl
8. Galanthamine
Molecular Weight | 368.3 g/mol |
---|---|
Molecular Formula | C17H22BrNO3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 1 |
Exact Mass | 367.07831 g/mol |
Monoisotopic Mass | 367.07831 g/mol |
Topological Polar Surface Area | 41.9 Ų |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 440 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
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Drug Name | Galantamine hydrobromide |
PubMed Health | Galantamine (By mouth) |
Drug Classes | Central Nervous System Agent |
Drug Label | Galantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide.... |
Active Ingredient | Galantamine hydrobromide |
Dosage Form | Tablet; Capsule, extended release; Solution |
Route | oral; Oral |
Strength | eq 4mg base; 8mg; eq 12mg base; 4mg; 4mg/ml; 12mg; eq 16mg base; eq 24mg base; eq 8mg base |
Market Status | Tentative Approval; Prescription |
Company | Ranbaxy; Apotex; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Sun Pharma Global; Roxane; Watson Labs; Teva Pharms; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs; Barr |
2 of 4 | |
---|---|
Drug Name | Razadyne |
Drug Label | RAZADYNE ER/RAZADYNE (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H... |
Active Ingredient | Galantamine hydrobromide |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 4mg base; eq 12mg base; 4mg/ml; eq 8mg base |
Market Status | Prescription |
Company | Janssen Pharms |
3 of 4 | |
---|---|
Drug Name | Galantamine hydrobromide |
PubMed Health | Galantamine (By mouth) |
Drug Classes | Central Nervous System Agent |
Drug Label | Galantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide.... |
Active Ingredient | Galantamine hydrobromide |
Dosage Form | Tablet; Capsule, extended release; Solution |
Route | oral; Oral |
Strength | eq 4mg base; 8mg; eq 12mg base; 4mg; 4mg/ml; 12mg; eq 16mg base; eq 24mg base; eq 8mg base |
Market Status | Tentative Approval; Prescription |
Company | Ranbaxy; Apotex; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Sun Pharma Global; Roxane; Watson Labs; Teva Pharms; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs; Barr |
4 of 4 | |
---|---|
Drug Name | Razadyne |
Drug Label | RAZADYNE ER/RAZADYNE (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H... |
Active Ingredient | Galantamine hydrobromide |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 4mg base; eq 12mg base; 4mg/ml; eq 8mg base |
Market Status | Prescription |
Company | Janssen Pharms |
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.)
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.)
Parasympathomimetics
Drugs that mimic the effects of parasympathetic nervous system activity. Included here are drugs that directly stimulate muscarinic receptors and drugs that potentiate cholinergic activity, usually by slowing the breakdown of acetylcholine (CHOLINESTERASE INHIBITORS). Drugs that stimulate both sympathetic and parasympathetic postganglionic neurons (GANGLIONIC STIMULANTS) are not included here. (See all compounds classified as Parasympathomimetics.)
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-05
Pay. Date : 2012-11-08
DMF Number : 18112
Submission : 2005-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26643
Submission : 2012-11-26
Status : Active
Type : II
Certificate Number : CEP 2023-389 - Rev 00
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 2366
Status : Valid
GDUFA
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Pay. Date :
DMF Number : 21989
Submission : 2008-11-26
Status : Active
Type : II
Certificate Number : R1-CEP 2011-123 - Rev 02
Issue Date : 2022-08-12
Type : Chemical
Substance Number : 2366
Status : Valid
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 17972
Submission : 2005-01-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-08-17
DMF Number : 17863
Submission : 2004-12-01
Status : Active
Type : II
Certificate Number : CEP 2011-011 - Rev 02
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 230MF10065
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Initial Date of Registration : 2018-05-15
Latest Date of Registration :
NDC Package Code : 65129-1332
Start Marketing Date : 2013-09-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-10-12
Registration Number : 20211012-209-J-1119
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27564
Submission : 2013-12-30
Status : Active
Type : II
NDC Package Code : 65129-1113
Start Marketing Date : 2004-04-29
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 : 17967
Submission : 2005-01-03
Status : Inactive
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-05
Pay. Date : 2012-11-08
DMF Number : 18112
Submission : 2005-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18045
Submission : 2005-01-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18152
Submission : 2005-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15384
Submission : 2001-05-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14425
Submission : 1999-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-24
Pay. Date : 2015-08-17
DMF Number : 17863
Submission : 2004-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18114
Submission : 2005-02-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17967
Submission : 2005-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17972
Submission : 2005-01-05
Status : Active
Type : II
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : CEP 2009-316 - Rev 03
Status : Valid
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Isolated From Natural ...
Certificate Number : R1-CEP 2011-288 - Rev 01
Status : Valid
Issue Date : 2020-11-19
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : R1-CEP 2012-248 - Rev 01
Status : Valid
Issue Date : 2021-11-19
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : R1-CEP 2011-123 - Rev 02
Status : Valid
Issue Date : 2022-08-12
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : CEP 2023-389 - Rev 00
Status : Valid
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : R1-CEP 2012-328 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2019-03-07
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Produced By A Syntheti...
Certificate Number : CEP 2011-011 - Rev 02
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 2366
Galantamine Hydrobromide, Isolated From Natural ...
Certificate Number : CEP 2011-053 - Rev 03
Status : Valid
Issue Date : 2025-01-13
Type : Chemical
Substance Number : 2366
Galantamine hydrobromide "Apitoria"
Registration Number : 306MF10088
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
Registration Number : 230MF10065
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Initial Date of Registration : 2018-05-15
Latest Date of Registration : 2022-01-26
Galantamine hydrobromide (Teva)
Registration Number : 231MF10027
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2019-02-05
Latest Date of Registration : 2019-02-05
Galantamine Hydrobromide Ph.Eur
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-10-15
Registration Number : 20211015-209-J-1014
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Sy No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy No's. 1, 2,...
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2023-03-15
Registration Number : 20211015-209-J-1014(1)
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Sy No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy No's. 1, 2,...
Registrant Name : Clinigen Korea Co., Ltd.
Registration Date : 2021-06-10
Registration Number : 20210610-209-J-538
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Jassen Pharmaceuticalaan 3, Geel, 2440, Belgium
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-10-12
Registration Number : 20211012-209-J-1119
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-10
Registration Number : 20210510-209-J-776
Manufacturer Name : Teva Czech Industries sro
Manufacturer Address : Ostravska 305/29, Komarov 747 70 Opava, Czech Republic.
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Details:
RJx-01 is a combination of galantamine and metformin, works by inhibiting AChE and acting as an allosteric modulator of nAChRs, being investigated for COPD-related muscle weakness.
Lead Product(s): Galantamine Hydrobromide,Metformin
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: National Institute for Health and Care Research
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 19, 2025
Lead Product(s) : Galantamine Hydrobromide,Metformin
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : National Institute for Health and Care Research
Deal Size : Inapplicable
Deal Type : Inapplicable
Rejuvenate Doses First Patient in Phase 2 Trial on COPD Muscle Weakness & Sarcopenia
Details : RJx-01 is a combination of galantamine and metformin, works by inhibiting AChE and acting as an allosteric modulator of nAChRs, being investigated for COPD-related muscle weakness.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 19, 2025
Details:
Galantamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Lead Product(s): Galantamine Hydrobromide,Striatin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 16, 2024
Lead Product(s) : Galantamine Hydrobromide,Striatin
Therapeutic Area : Undisclosed
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
Details : Galantamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 16, 2024
Details:
Essential Pharma has acquired rights to Reminyl (galantamine), a cholinesterase inhibitor, for the EEA, Thailand, South Korea, and other markets, excluding the UK and Japan.
Lead Product(s): Galantamine Hydrobromide,Inapplicable
Therapeutic Area: Neurology Brand Name: Reminyl
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Essential Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 17, 2024
Lead Product(s) : Galantamine Hydrobromide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Essential Pharma
Deal Size : Undisclosed
Deal Type : Acquisition
Essential Pharma Acquires Reminyl® (galantamine hydrobromide) Capsules
Details : Essential Pharma has acquired rights to Reminyl (galantamine), a cholinesterase inhibitor, for the EEA, Thailand, South Korea, and other markets, excluding the UK and Japan.
Product Name : Reminyl
Product Type : Miscellaneous
Upfront Cash : Undisclosed
April 17, 2024
Details:
RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy.
Lead Product(s): Galantamine Hydrobromide,Metformin
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 04, 2023
Lead Product(s) : Galantamine Hydrobromide,Metformin
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 04, 2023
Details:
RJx-01 is a novel combination of known drugs, there are already extensive safety data available for the constituent compounds. Results will be based on a combination of classic and hi-tech assessment techniques, including data from wearable health tech devices.
Lead Product(s): Galantamine Hydrobromide,Inapplicable
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2022
Lead Product(s) : Galantamine Hydrobromide,Inapplicable
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Rejuvenate Biomed Started a Groundbreaking Clinical Trial and Expands for Future Growth
Details : RJx-01 is a novel combination of known drugs, there are already extensive safety data available for the constituent compounds. Results will be based on a combination of classic and hi-tech assessment techniques, including data from wearable health tech d...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 29, 2022
CAS Number : 510-77-0
End Use API : Galantamine Hydrobromide
About The Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in...
RLD : No
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 8MG BASE
Approval Date : 2009-02-11
Application Number : 77608
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 24MG BASE
Approval Date : 2009-05-27
Application Number : 78484
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE ER
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-04-01
Application Number : 21615
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE ER
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-04-01
Application Number : 21615
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2009-06-22
Application Number : 77589
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 12MG BASE
Approval Date : 2008-09-11
Application Number : 77593
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET; ORAL
Dosage Strength : 12MG
Approval Date :
Application Number : 77588
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AB
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2011-02-17
Application Number : 78898
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2008-08-28
Application Number : 77603
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 16MG BASE
Approval Date : 2011-01-24
Application Number : 90900
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Galantamina Pharmathen
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 2011-11-08
Application Number : 74366
Regulatory Info : Cancelled
Registration Country : Spain
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Galantamina Pharmathen
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 16MG
Packaging :
Approval Date : 2011-11-08
Application Number : 74367
Regulatory Info : Cancelled
Registration Country : Spain
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Galantamina Pharmathen
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 24MG
Packaging :
Approval Date : 2011-11-08
Application Number : 74368
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Galantamina Aurobindo
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 2018-11-11
Application Number : 83585
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Galantamina Aurobindo
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 24MG
Packaging :
Approval Date : 2018-11-11
Application Number : 83584
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info :
Registration Country : Norway
Brand Name : Reminyl
Dosage Form : Pit capsule, hard
Dosage Strength : 16 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Reminiyl
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 24MG
Packaging :
Approval Date : 2021-08-25
Application Number : 29843-08-05-2008
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Galnora
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 16MG
Packaging :
Approval Date : 2012-03-23
Application Number : 74330
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Galnora
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 24MG
Packaging :
Approval Date : 2012-03-23
Application Number : 74331
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Galantamine Normon
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 2014-02-11
Application Number : 78442
Regulatory Info : Authorized
Registration Country : Spain
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Suspension
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
Dosage Form : Suspension
Grade : Oral, Topical
Application : Rheology Modifiers
Excipient Details : HPMC 60HD4000 is used as thickener and viscosity modifier in oral solid, liquid and topical dosage forms.
Dosage Form : Suspension
Grade : Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Syrup
Grade : Oral
Application : Taste Masking
Excipient Details : Sodium Saccharin (Q-0300, 15-191201) is used as an artificial sweetener in tablets, syrup, suspensions, liquids, and mouthwashes.
Pharmacopoeia Ref : USP/NF, JP, Kosher, ISO, Halal...
Technical Specs : 15% MOISTURE, Min. 98% Purity
Ingredient(s) : Sodium Saccharin Excipient
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule
Grade : Oral (Pharma Grade)
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : Lubristar is used as a lubricant in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, PSD, DMF, ...
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant in oral solid dosage forms such as tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Solvostar 2% to 8%
Ingredient(s) : Sodium Starch Glycolate
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Topical, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Dosage Form : Capsule
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate (SSF) is an inert, tablet lubricant used in orally disintegrating tablets (ODTs) and effervescent formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Stearyl Fumarate
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Application : Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : D-Mannitol
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Thickeners and Stabilizers
Excipient Details : Sucrose is used to stabilize proteins, lipids, carbohydrates, ADCs & vaccines. It is also used as a cryopreservative in cell-based bioprocesses.
Pharmacopoeia Ref : USP NF, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Sucrose
Excipients by Applications
https://www.pharmacompass.com/radio-compass-blog/fda-s-landmark-approvals-of-bms-schizo-med-madrigal-s-mash-drug-us-16-5-bn-catalent-buyout-make-it-to-top-10-news-of-2024
Global Sales Information
Company : Aurobindo Pharm
Galantamine HBr
Drug Cost (USD) : 8,916,121
Year : 2023
Prescribers : 19860
Prescriptions : 83587
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Bryant Ranch Pr
Galantamine HBr
Drug Cost (USD) : 1,038
Year : 2023
Prescribers :
Prescriptions : 14
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Patriot Pharmac
Galantamine HBr
Drug Cost (USD) : 75,388
Year : 2023
Prescribers : 449
Prescriptions : 977
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Sun Pharma Glob
Galantamine HBr
Drug Cost (USD) : 4,471,152
Year : 2023
Prescribers : 12885
Prescriptions : 40711
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Aurobindo Pharm
Galantamine HBr
Drug Cost (USD) : 3,561,574
Year : 2023
Prescribers : 9733
Prescriptions : 45222
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Major Pharmaceu
Galantamine HBr
Drug Cost (USD) : 5,384
Year : 2023
Prescribers : 31
Prescriptions : 61
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Rising Pharm
Galantamine HBr
Drug Cost (USD) : 3,638,017
Year : 2023
Prescribers : 10771
Prescriptions : 44670
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Slate Run Pharm
Galantamine HBr
Drug Cost (USD) : 1,838,342
Year : 2023
Prescribers : 5985
Prescriptions : 21483
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Zydus Pharmaceu
Galantamine HBr
Drug Cost (USD) : 1,240
Year : 2023
Prescribers : 11
Prescriptions : 19
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Roxane/West-War
Galantamine HBr
Drug Cost (USD) : 311,443
Year : 2023
Prescribers : 162
Prescriptions : 686
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Reply
14 Apr 2025
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14 Apr 2025
Reply
20 Nov 2024
Reply
29 Aug 2024
Reply
04 May 2024
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21 Sep 2019
Reply
16 Apr 2019
Reply
28 Jul 2018
Patents & EXCLUSIVITIES
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Brand Name : REMINYL
Patent Number : 2310950
Filing Date : 2000-06-27
Strength per Unit : 4 mg/ml
Dosage Form : Oral Solution
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Brand Name : REMINYL
Patent Number : 2310926
Filing Date : 2000-06-27
Strength per Unit : 4 mg/ml
Dosage Form : Oral Solution
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Brand Name : REMINYL ER
Patent Number : 2310926
Filing Date : 2000-06-27
Strength per Unit : 8 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
Brand Name : REMINYL ER
Patent Number : 2358062
Filing Date : 1999-12-20
Strength per Unit : 8 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Brand Name : REMINYL ER
Patent Number : 2310950
Filing Date : 2000-06-27
Strength per Unit : 8 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Brand Name : REMINYL ER
Patent Number : 2310926
Filing Date : 2000-06-27
Strength per Unit : 16 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
Brand Name : REMINYL ER
Patent Number : 2358062
Filing Date : 1999-12-20
Strength per Unit : 16 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Brand Name : REMINYL ER
Patent Number : 2310950
Filing Date : 2000-06-27
Strength per Unit : 16 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2005-11-08
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Brand Name : REMINYL ER
Patent Number : 2310926
Filing Date : 2000-06-27
Strength per Unit : 24 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2020-06-27
Date Granted : 2002-10-15
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
Brand Name : REMINYL ER
Patent Number : 2358062
Filing Date : 1999-12-20
Strength per Unit : 24 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2019-12-20
Date Granted : 2006-12-19
REF. STANDARDS & IMPURITIES
Galantamine synthetic for system suitability
CAS Number : 1953-04-4
Quantity Per Vial : 5 mg
Sale Unit : 1
Order Code : Y0001191
Batch No : 2
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 1953-04-4
Quantity Per Vial : 10 mg
Sale Unit : 1
Order Code : Y0001201
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
Galantamine natural for system suitability
CAS Number : 1953-04-4
Quantity Per Vial : 10 mg
Sale Unit : 1
Order Code : Y0001190
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 1953-04-4
Quantity Per Vial : 10 mg
Sale Unit : 1
Order Code : Y0001279
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
ABOUT THIS PAGE
28
PharmaCompass offers a list of Galantamine Hydrobromide 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 Galantamine Hydrobromide manufacturer or Galantamine Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Galantamine Hydrobromide manufacturer or Galantamine Hydrobromide supplier.
PharmaCompass also assists you with knowing the Galantamine Hydrobromide API Price utilized in the formulation of products. Galantamine Hydrobromide API Price is not always fixed or binding as the Galantamine Hydrobromide Price is obtained through a variety of data sources. The Galantamine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Galantamine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galantamine Hydrobromide, including repackagers and relabelers. The FDA regulates Galantamine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galantamine Hydrobromide 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 Galantamine Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Galantamine Hydrobromide supplier is an individual or a company that provides Galantamine Hydrobromide active pharmaceutical ingredient (API) or Galantamine Hydrobromide finished formulations upon request. The Galantamine Hydrobromide suppliers may include Galantamine Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Galantamine Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Galantamine Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Galantamine Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Galantamine Hydrobromide DMFs exist exist since differing nations have different regulations, such as Galantamine Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galantamine Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Galantamine Hydrobromide USDMF includes data on Galantamine Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galantamine Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galantamine Hydrobromide 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 Galantamine Hydrobromide Drug Master File in Japan (Galantamine Hydrobromide JDMF) empowers Galantamine Hydrobromide 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 Galantamine Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Galantamine Hydrobromide 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 Galantamine Hydrobromide 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 Galantamine Hydrobromide Drug Master File in Korea (Galantamine Hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Galantamine Hydrobromide. The MFDS reviews the Galantamine Hydrobromide KDMF as part of the drug registration process and uses the information provided in the Galantamine Hydrobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Galantamine Hydrobromide 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 Galantamine Hydrobromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Galantamine Hydrobromide suppliers with KDMF on PharmaCompass.
A Galantamine Hydrobromide CEP of the European Pharmacopoeia monograph is often referred to as a Galantamine Hydrobromide Certificate of Suitability (COS). The purpose of a Galantamine Hydrobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Galantamine Hydrobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Galantamine Hydrobromide to their clients by showing that a Galantamine Hydrobromide CEP has been issued for it. The manufacturer submits a Galantamine Hydrobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Galantamine Hydrobromide CEP holder for the record. Additionally, the data presented in the Galantamine Hydrobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Galantamine Hydrobromide DMF.
A Galantamine Hydrobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Galantamine Hydrobromide 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 Galantamine Hydrobromide suppliers with CEP (COS) on PharmaCompass.
A Galantamine Hydrobromide written confirmation (Galantamine Hydrobromide WC) is an official document issued by a regulatory agency to a Galantamine Hydrobromide manufacturer, verifying that the manufacturing facility of a Galantamine Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Galantamine Hydrobromide APIs or Galantamine Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Galantamine Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Galantamine Hydrobromide 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 Galantamine Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galantamine Hydrobromide 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 Galantamine Hydrobromide 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 Galantamine Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galantamine Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galantamine Hydrobromide suppliers with NDC on PharmaCompass.
Galantamine Hydrobromide 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 Galantamine Hydrobromide 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 Galantamine Hydrobromide GMP manufacturer or Galantamine Hydrobromide GMP API supplier for your needs.
A Galantamine Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Galantamine Hydrobromide's compliance with Galantamine Hydrobromide specifications and serves as a tool for batch-level quality control.
Galantamine Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Galantamine Hydrobromide 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.
Galantamine Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Galantamine Hydrobromide EP), Galantamine Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galantamine Hydrobromide USP).