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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 2 EU WC, 5 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

29 API Suppliers
15 USDMF
8 CEP/COS
4 JDMF
2 EU WC
5 KDMF
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 71 FDA Orange Book, 110 Europe, 15 Canada, 24 Australia, 9 South Africa, 17 Listed Dossiers

246 FDF Dossiers
71 FDA Orange Book
110 Europe
15 Canada
24 Australia
9 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

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

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93 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 48 Direct Compression, 35 Disintegrants & Superdisintegrants, 33 Thickeners and Stabilizers, 33 Controlled & Modified Release, 30 Granulation, 26 Solubilizers, 23 Taste Masking, 22 Lubricants & Glidants, 20 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 18 Film Formers & Plasticizers, 17 Parenteral, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 96 Finished Drug Prices, 6 Annual Reports

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3 US Medicaid Prescriptions
96 Finished Drug Prices
6 Annual Reports

MARKET PLACE

5 APIs

marketPlace
5 APIs

PATENTS & EXCLUSIVITIES

20 Health Canada Patents

patents
20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM , 3 USP , 3 Others

otherSolutions
4 EDQM
3 USP
3 Others

Capital Farma Galantamine Hydrobromide

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,234

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

246

FDF Dossiers

FDA Orange Book

110

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

8,305,270

Annual Reports (USD Million)

736

Finished Drug Prices

306 RELATED EXCIPIENT COMPANIES

526EXCIPIENTS BY APPLICATIONS

Chemistry

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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

Galantamine Hydrobromide

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*)-

2.3.3 Other Synonyms

1. Galantamine

2. Galanthamine Hydrobromide

3. Lycoremin

4. Lycoremine

5. Nivalin

6. Razadyne

7. Reminyl

8. Galanthamine

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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GALANTAMINE HYDROBROMIDE

NDC Package Code : 55111-081

Start Marketing Date : 2005-01-20

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Janssen Pharmaceutica NV

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Not Confirmed

04

Jubilant Pharmova Limited

India

Fi Europe 2024

Not Confirmed

05

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

01

WATSON LABS

Ireland

BMWS24

Not Confirmed

02

AUROBINDO PHARMA LTD

BMWS24

Not Confirmed

08

MYLAN

U.S.A

BMWS24

Not Confirmed

09

NORVIUM BIOSCIENCE

Country

BMWS24

Not Confirmed

10

NORVIUM BIOSCIENCE

Country

BMWS24

Not Confirmed

Only 10 entries up to this point, click to access all

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Europe

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21169

DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21169

DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21169

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21615

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21615

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21615

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