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Labetalol Hydrochloride

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 19 USDMF, 6 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 16 Listed Suppliers, $ API Reference Price

32 API Suppliers
19 USDMF
6 CEP/COS
4 JDMF
4 EU WC
13 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

129 FDF Dossiers, 78 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 2 South Africa, 24 Listed Dossiers

129 FDF Dossiers
78 FDA Orange Book
12 Europe
11 Canada
2 Australia
2 South Africa
24 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 31 Disintegrants & Superdisintegrants, 28 Controlled & Modified Release, 24 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 13 Topical, 12 Film Formers & Plasticizers, 11 Parenteral, 9 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 7 Taste Masking, 6 API Stability Enhancers, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

12 Finished Drug Prices

globalSalesInformation
12 Finished Drug Prices

MARKET PLACE

23 APIs, 11 FDF Dossiers

marketPlace
23 APIs
11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 2 Others

otherSolutions
3 EDQM
1 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 187

MARKET PLACE

API

FDF

10INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

129

FDF Dossiers

FDA Orange Book

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)

Annual Reports (USD Million)

Finished Drug Prices

228 RELATED EXCIPIENT COMPANIES

387EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 32780-64-6, Labetalol hcl, Amipress, Presdate, Normodyne, Trandate

Molecular Formula

C₁₉H₂₅ClN₂O₃

Molecular Weight

364.9 g/mol

InChI Key

WQVZLXWQESQGIF-UHFFFAOYSA-N

FDA UNII

1GEV3BAW9J

A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS.

1 2D Structure

Labetalol Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide;hydrochloride

2.1.2 InChI

InChI=1S/C19H24N2O3.ClH/c1-13(7-8-14-5-3-2-4-6-14)21-12-18(23)15-9-10-17(22)16(11-15)19(20)24;/h2-6,9-11,13,18,21-23H,7-8,12H2,1H3,(H2,20,24);1H

2.1.3 InChI Key

WQVZLXWQESQGIF-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(CCC1=CC=CC=C1)NCC(C2=CC(=C(C=C2)O)C(=O)N)O.Cl

2.2 Other Identifiers

2.2.1 UNII

1GEV3BAW9J

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Ah 5158

2. Ah-5158

3. Ah5158

4. Albetol

5. Apo Labetalol

6. Apo-labetalol

7. Apolabetalol

8. Dilevalol

9. Hydrochloride, Labetalol

10. Labetalol

11. Labetalol, (r,r)-isomer

12. Labetolol

13. Normodyne

14. Presolol

15. R,r Labetalol

16. R,r-labetalol

17. Sch 19927

18. Sch-19927

19. Sch19927

20. Trandate

2.3.2 Depositor-Supplied Synonyms

1. 32780-64-6

2. Labetalol Hcl

3. Amipress

4. Presdate

5. Normodyne

6. Trandate

7. Labetalol (hydrochloride)

8. Sch 15719w

9. Ah 5158a

10. Sch-15719w

11. 2-hydroxy-5-(1-hydroxy-2-((4-phenylbutan-2-yl)amino)ethyl)benzamide Hydrochloride

12. Ibidomide Hydrochloride

13. Labetalol Hydrochloride

14. Ah-5158a

15. 1gev3baw9j

16. Nsc-290312

17. 32780-64-6 (hcl)

18. Mls000069666

19. Ah-5158a Hydrochloride

20. Sch-15719w Hydrochloride

21. 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide Hydrochloride

22. 5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide Monohydrochloride

23. Ah-5158 Hydrochloride;sch-15719w

24. Labetalol Hcl (mixture Of Diastereomers)

25. Labrocol

26. Pressalolo

27. Smr000058463

28. Ipolab

29. 2-hydroxy-5-(1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl)benzamide Hcl

30. 2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide Hydrochloride

31. 2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide;hydrochloride

32. 5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide Hydrochloride

33. 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide Hydrochloride

34. 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide Monohydrochloride

35. Benzamide, 2-hydroxy-5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)-, Monohydrochloride

36. Dsstox_cid_24654

37. Dsstox_rid_80378

38. Dsstox_gsid_44654

39. Ccris 1086

40. Sr-01000000209

41. Einecs 251-211-1

42. Unii-1gev3baw9j

43. Nsc 290312

44. 2-hydroxy-5-(1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl)benzamide Hydrochloride

45. 2-hydroxy-5-(1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl)benzamide Hydrochloride

46. Normodyne (tn)

47. Trandate (tn)

48. Prestwick_290

49. Einecs 276-694-6

50. Mfcd00057663

51. Labetalolhydrochloride

52. Labetalol Hydrochloride [usan:usp:jan]

53. Ah-5158 Hydrochloride

54. La.beta.lol Hydrochloride

55. Opera_id_1625

56. Benzamide,monohydrochloride

57. Ncgc00016810-01

58. Salicylamide, Hydrochloride

59. Cas-32780-64-6

60. Salicylamide, 5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)-, Hydrochloride

61. Schembl41230

62. 72487-34-4

63. Mls001148626

64. Mls002222197

65. Spectrum1503243

66. Chebi:6344

67. Chembl1200323

68. Dtxsid0044654

69. Amy8842

70. Hms1568h16

71. Hms1922m13

72. Pharmakon1600-01503243

73. 72487-35-5

74. Bcp13886

75. Ex-a4940

76. Hy-b1108

77. Labetalol Hydrochloride [mi]

78. Tox21_110623

79. Tox21_302725

80. Tox21_500687

81. Ccg-40314

82. Labetalol Hydrochloride (jp17/usp)

83. Labetalol Hydrochloride [jan]

84. Nsc290312

85. Nsc758438

86. S4291

87. Labetalol Hydrochloride [usan]

88. Akos015895575

89. Ac-1389

90. Ah-5158

91. Cs-4706

92. Labetalol Hydrochloride [mart.]

93. Labetalol Hydrochloride [vandf]

94. Lp00687

95. Nc00571

96. Nsc-758438

97. Ss-4219

98. Labetalol Hydrochloride [usp-rs]

99. Labetalol Hydrochloride [who-dd]

100. Ncgc00094044-01

101. Ncgc00094044-02

102. Ncgc00094044-03

103. Ncgc00094044-04

104. Ncgc00094044-05

105. Ncgc00256847-01

106. Ncgc00261372-01

107. (r*,r*)-(1)-5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide Monohydrochloride

108. Benzamide,2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-, Hydrochloride(1:1)

109. Db-048265

110. Eu-0100687

111. Ft-0630564

112. Ft-0773231

113. Labetalol Hydrochloride [orange Book]

114. Sw196595-3

115. Labetalol Hydrochloride [ep Monograph]

116. D00600

117. Labetalol Hydrochloride [usp Monograph]

118. Labetalol Hydrochloride, >98% (tlc), Powder

119. 780l646

120. Normozide Component Labetalol Hydrochloride

121. Sr-01000000209-2

122. Sr-01000000209-7

123. Labetalol Hydrochloride Component Of Normozide

124. Q27252396

125. 2-hydroxy-5-(1-hydroxy-2-((4-phenylbutan-2-yl)amino)ethyl)benzamide Hcl

126. Labetalol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

127. Labetalol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

128. Labetalol Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

129. Benzamide, 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-, Hydrochloride (1:1)

130. Benzamide,2-hydroxy-5-[(1s)-1-hydroxy-2-[[(1r)-1-methyl-3-phenylpropyl]amino]ethyl]-,hydrochloride (1:1), Rel-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₅ClN₂O₃
Molecular Weight	364.9 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	8
Exact Mass	364.1553704 g/mol
Monoisotopic Mass	364.1553704 g/mol
Topological Polar Surface Area	95.6 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	385
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Labetalol hydrochloride
Drug Label	Labetalol HCl USP tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance.Labetalol HCl USP is a racemate, chemically designated as 5...
Active Ingredient	Labetalol hydrochloride
Dosage Form	Tablet; Injectable
Route	Injection; Oral
Strength	200mg; 300mg; 5mg/ml; 100mg
Market Status	Prescription
Company	Hospira; Gland Pharma; Sandoz; Watson Labs; Ivax Sub Teva Pharms; Eurohlth Intl; Par Form; Akorn

2 of 2
Drug Name	Labetalol hydrochloride
Drug Label	Labetalol HCl USP tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance.Labetalol HCl USP is a racemate, chemically designated as 5...
Active Ingredient	Labetalol hydrochloride
Dosage Form	Tablet; Injectable
Route	Injection; Oral
Strength	200mg; 300mg; 5mg/ml; 100mg
Market Status	Prescription
Company	Hospira; Gland Pharma; Sandoz; Watson Labs; Ivax Sub Teva Pharms; Eurohlth Intl; Par Form; Akorn

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic beta-Antagonists

Drugs that bind to but do not activate beta-adrenergic receptors thereby blocking the actions of beta-adrenergic agonists. Adrenergic beta-antagonists are used for treatment of hypertension, cardiac arrhythmias, angina pectoris, glaucoma, migraine headaches, and anxiety. (See all compounds classified as Adrenergic beta-Antagonists.)

Sympathomimetics

Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)

Adrenergic alpha-1 Receptor Antagonists

Drugs that bind to and block the activation of ADRENERGIC ALPHA-1 RECEPTORS. (See all compounds classified as Adrenergic alpha-1 Receptor Antagonists.)

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BioFlorida Conference

Attending

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Attending

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Booth #2.D38

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

TIDES Europe 2024

Exhibiting

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC

NDC

KDMF VMF Others AUDIT

05

Teva API

Israel

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

World Vaccine Congress

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API Reference Price

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INC","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"578.4","totalValueFC":"29162.8","currency":"USD","unitRateINR":"48755","date":"10-Jul-2024","totalValueINR":"2437752","totalValueInUsd":"29162.8","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29242970","bill_no":"1001092","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"VIA MATTEOTTI 249 28062 CAMERI 0 ITALY","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721327400,"product":"LABETALOL HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"M\/S.PROCOSS S.P.A.","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"1702.00","actualQuantity":"1702","unit":"KGS","unitRateFc":"186.7","totalValueFC":"321468.8","currency":"USD","unitRateINR":"15788.4","date":"19-Jul-2024","totalValueINR":"26871922","totalValueInUsd":"321468.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"1002636","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"LABETALOL HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"PROCOS","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"3.14","actualQuantity":"3.14","unit":"KGS","unitRateFc":"800","totalValueFC":"2540.8","currency":"USD","unitRateINR":"67640","date":"30-Jul-2024","totalValueINR":"212389.6","totalValueInUsd":"2540.8","indian_port":"Madras Air","hs_no":"29242990","bill_no":"4785200","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"Via Matteotti 24928062 Cameri (NO)ITALY IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"}]

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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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18716

DOSAGE - TABLET;ORAL - 200MG **Federal Regist...DOSAGE - TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18716

DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18716

DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18716

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

19 USDMF

6 CEP/COS

4 JDMF

4 EU WC

13 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

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10 Intermediates Suppliers

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129 FDF Dossiers

78 FDA Orange Book

12 Europe

11 Canada

2 Australia

2 South Africa

24 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders

51 Coating Systems & Additives

36 Direct Compression

31 Disintegrants & Superdisintegrants

28 Controlled & Modified Release

24 Thickeners and Stabilizers

20 Granulation

18 Solubilizers

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons