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Technical details about Galantamine Hydrobromide, learn more about the structure, uses, toxicity, action, side effects and more

Galantamine Hydrobromide

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

20 Suppliers, 12 USDMF, 8 CEP/COS, 3 JDMF, 2 EU WC, 5 KDMF, 6 NDC API, 5 Listed Suppliers

DEVELOPMENTS

1 Drug(s) in Development

1 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

1 Suppliers

1 Suppliers

DOSSIERs // Finished Dosage Forms

113 Dossiers, 71 FDA Orange Book, 24 Europe, 15 Canada, 3 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE

RELATED EXCIPIENT COMPANIES

Suppliers, 37 Kerry, 30 BASF, 19 Roquette, 17 SPI Pharma, 15 Microlex e.U, 14 Seppic, 11 Corel Pharma Chem, 11 Sigachi Industries, 11 Gangwal Chemicals, 11 Gangwal Healthcare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 DKSH, 7 Actylis, 6 Lonza Capsugel, 6 DFE Pharma, 5 Boai NKY Pharmaceuticals Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 5 Nanjing Well Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Pharmatrans-Sanaq, 4 Ingredion Pharma Solutions, 4 Kima Chemical, 4 ACG Worldwide, 4 Prachin Chemical, 3 Vasa Pharmachem, 3 The Dow Chemical Company, 2 Qualicaps, 2 Rochem International Inc, 2 Alcedo Pharmachem, 2 Pfanstiehl, 2 Seqens, 2 Finar, 2 Vertellus, 2 Nomisma Healthcare, 2 Ulanqab Kema New Material, 2 Jai Radhe Sales, 1 Valens Pharmachem, 1 Shijiazhuang Huaxu Pharmaceutical, 1 NEWEDGE Overseas, 1 Clariant, 1 Chynops Pharma, 1 Minakem, 1 Nanjing Bold Chemical, 1 Aeon Procare, 1 Qianhao Chemical (Hebei) Co., Ltd

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 43 Direct Compression, 34 Disintegrants & Superdisintegrants, 33 Controlled & Modified Release, 31 Thickeners and Stabilizers, 29 Granulation, 26 Solubilizers, 23 Taste Masking, 21 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 17 Parenteral, 17 Film Formers & Plasticizers, 16 Co-Processed Excipients, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 21 Finished Drug Prices

MARKET PLACE

3 APIs

3 APIs

PATENTS

20 Health Canada Patents

20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 3 Others

DIGITAL CONTENT

3 News

3 News

1. Also known as: Galanthamine hydrobromide, 1953-04-4, Reminyl, Nivalin, Nivaline, Razadyne

Molecular Formula

C₁₇H₂₂BrNO₃

Molecular Weight

368.3 g/mol

InChI Key

QORVDGQLPPAFRS-XPSHAMGMSA-N

FDA UNII

MJ4PTD2VVW

A benzazepine derived from norbelladine. It is found in GALANTHUS and other AMARYLLIDACEAE. It is a cholinesterase inhibitor that has been used to reverse the muscular effects of GALLAMINE TRIETHIODIDE and TUBOCURARINE and has been studied as a treatment for ALZHEIMER DISEASE and other central nervous system disorders.

1 2D Structure

2D Structure

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(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

2.1.2 InChI

InChI=1S/C17H21NO3.BrH/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17;/h3-6,12,14,19H,7-10H2,1-2H3;1H/t12-,14-,17-;/m0./s1

2.1.3 InChI Key

QORVDGQLPPAFRS-XPSHAMGMSA-N

2.1.4 Canonical SMILES

CN1CCC23C=CC(CC2OC4=C(C=CC(=C34)C1)OC)O.Br

2.1.5 Isomeric SMILES

CN1CC[C@@]23C=C[C@@H](C[C@@H]2OC4=C(C=CC(=C34)C1)OC)O.Br

2.2 Other Identifiers

2.2.1 UNII

MJ4PTD2VVW

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Galantamin

2. Galantamine

3. Galanthamine

4. Galanthamine Hydrobromide

5. Lycoremine

6. Nivalin

7. Nivaline

8. Razadyne

9. Reminyl

2.3.2 Depositor-Supplied Synonyms

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*)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₂BrNO₃
Molecular Weight	368.3 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

1 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

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

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cholinesterase Inhibitors [MoA]; Cholinesterase Inhibitor [EPC]

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