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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

Labetalol Hydrochloride
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 Weight 364.9 g/mol
Molecular Formula C19H25ClN2O3
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count4
Rotatable Bond Count8
Exact Mass364.1553704 g/mol
Monoisotopic Mass364.1553704 g/mol
Topological Polar Surface Area95.6 Ų
Heavy Atom Count25
Formal Charge0
Complexity385
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameLabetalol hydrochloride
Drug LabelLabetalol 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 IngredientLabetalol hydrochloride
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength200mg; 300mg; 5mg/ml; 100mg
Market StatusPrescription
CompanyHospira; Gland Pharma; Sandoz; Watson Labs; Ivax Sub Teva Pharms; Eurohlth Intl; Par Form; Akorn

2 of 2  
Drug NameLabetalol hydrochloride
Drug LabelLabetalol 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 IngredientLabetalol hydrochloride
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength200mg; 300mg; 5mg/ml; 100mg
Market StatusPrescription
CompanyHospira; 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]

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Certificate Number : R1-CEP 1998-119 - Rev 01

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Labetalol Hydrochloride GR

Registration Number : 224MF10101

Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

Initial Date of Registration : 2012-05-25

Latest Date of Registration : 2012-05-25

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Labetalol Hydrochloride

Registration Number : 218MF10992

Registrant's Address : Via Matteotti 249,28062 CAMERI(NOVARA)/ITALY 

Initial Date of Registration : 2006-12-18

Latest Date of Registration : 2006-12-18

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Labetalol hydrochloride (Teva 2)

Registration Number : 226MF10014

Registrant's Address : Piazzale Luigi Cadorna, 4-20123 MILANO, Italy

Initial Date of Registration : 2014-01-21

Latest Date of Registration : 2014-01-21

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Labetalol Hydrochloride USP/Ph. Eur

Date of Issue : 2022-06-07

Valid Till : 2025-06-16

Written Confirmation Number : WC-0037

Address of the Firm : Unit II Plot No. 92-94, 257-259, IDA, Pashamylaram, Isnapur Village, Patancheru ...

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Labetalol Hydrochloride USP

Date of Issue : 2022-09-01

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Written Confirmation Number : WC-0074Amended

Address of the Firm : 294, GIDC Estate Ankleshwar, Bharuch-393002, Gujarat India

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Date of Issue : 2022-07-11

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Written Confirmation Number : WC-0228n

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Date of Issue : 2023-07-10

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Date of Issue : 2023-05-15

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LABETALOL HYDROCHLORIDE

NDC Package Code : 58032-2025

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LABETALOL HYDROCHLORIDE

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NDC Package Code : 46016-0117

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Labetalol Hydrochloride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

02

  • fda
  • EDQM
  • WHO-GMP

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

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Labetalol Hydrochloride

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
Nuray Chemicals

03

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Labetalol Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

04

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Labetalol Hydrochloride

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
Neuland

05

Cosma

Italy
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  • WHO-GMP

Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.

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Labetalol Hydrochloride

About the Company : Cosma S.p.A., established in 1977 in Bergamo, northern Italy, is the largest manufacturing site within the CFM group, with a 130,000L (130 m³) glass-lined reaction volume and over...

Cosma S.p.A., established in 1977 in Bergamo, northern Italy, is the largest manufacturing site within the CFM group, with a 130,000L (130 m³) glass-lined reaction volume and over 300 tons of annual API output. Originally founded to introduce the CFM group into the U.S. generic market, Cosma was FDA-approved in 1984 and continues to export over 50% of its production to the U.S. Today, Cosma supports leading global generic and branded pharmaceutical companies, while also maintaining a strong presence in the animal health sector. Covering more than 5,000 m², Cosma is recognized for its scale, regulatory excellence, and reliability.
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06

Georgia Environmental
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Georgia Environmental
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Labetalol

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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07

Georgia Environmental
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Georgia Environmental
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Labetalol

About the Company : Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in mark...

Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.
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08

Georgia Environmental
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Georgia Environmental
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Labetalol Hydrochloride

About the Company : Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing p...

Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing patients across geographies and bridging the gap of unmet needs of medical fraternity through continuous innovation. Our basic business philosophy, by its very nature, serves a social responsibility hence we have a far better reason than profits alone to drive our performance. Sustainability, is not a trend we blindly follow, it is intrinsic to how we have operated since the genesis of the organization in the year 1986.
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09

Procos

Italy
Georgia Environmental
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Procos

Italy
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Georgia Environmental
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Labetalol Hydrochloride

About the Company : Procos S.p.A. is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients...

Procos S.p.A. is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and Generic API manufacturing. The manufacturing site is located in Cameri, Italy. This 110,000 sq. meter, cutting-edge multipurpose plant, fully designed under cGMP compliance, has been successfully audited and approved by the main regulatory authorities including AIFA, FDA and PMDA.
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10

Symed Labs

India
Georgia Environmental
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Symed Labs

India
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Georgia Environmental
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Labetalol Hydrochloride

About the Company : Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemist...

Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. We are more than 300 employees strong and our core competence is in the application of strong process chemistry to manufacturing in a regulatory environment. For the past 15 years, Symed has been at the forefront of facilitating and accelerating drug development (and GMP manufacturing) of APIs. The company's technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.
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06-Jan-2022
29-Jul-2025
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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

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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

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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

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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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ABOUT THIS PAGE

Looking for 32780-64-6 / Labetalol Hydrochloride API manufacturers, exporters & distributors?

Labetalol Hydrochloride manufacturers, exporters & distributors 1

64

PharmaCompass offers a list of Labetalol Hydrochloride 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 Labetalol Hydrochloride manufacturer or Labetalol Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Labetalol Hydrochloride manufacturer or Labetalol Hydrochloride supplier.

PharmaCompass also assists you with knowing the Labetalol Hydrochloride API Price utilized in the formulation of products. Labetalol Hydrochloride API Price is not always fixed or binding as the Labetalol Hydrochloride Price is obtained through a variety of data sources. The Labetalol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Labetalol Hydrochloride

Synonyms

32780-64-6, Labetalol hcl, Amipress, Presdate, Normodyne, Trandate

Cas Number

32780-64-6

Unique Ingredient Identifier (UNII)

1GEV3BAW9J

About Labetalol Hydrochloride

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

Labetalol Hydrochloride Manufacturers

A Labetalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Labetalol Hydrochloride, including repackagers and relabelers. The FDA regulates Labetalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Labetalol Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Labetalol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Labetalol Hydrochloride Suppliers

A Labetalol Hydrochloride supplier is an individual or a company that provides Labetalol Hydrochloride active pharmaceutical ingredient (API) or Labetalol Hydrochloride finished formulations upon request. The Labetalol Hydrochloride suppliers may include Labetalol Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Labetalol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Labetalol Hydrochloride USDMF

A Labetalol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Labetalol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Labetalol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Labetalol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Labetalol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Labetalol Hydrochloride USDMF includes data on Labetalol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Labetalol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Labetalol Hydrochloride suppliers with USDMF on PharmaCompass.

Labetalol Hydrochloride JDMF

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 Labetalol Hydrochloride Drug Master File in Japan (Labetalol Hydrochloride JDMF) empowers Labetalol Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Labetalol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Labetalol Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Labetalol Hydrochloride suppliers with JDMF on PharmaCompass.

Labetalol Hydrochloride CEP

A Labetalol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Labetalol Hydrochloride Certificate of Suitability (COS). The purpose of a Labetalol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Labetalol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Labetalol Hydrochloride to their clients by showing that a Labetalol Hydrochloride CEP has been issued for it. The manufacturer submits a Labetalol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Labetalol Hydrochloride CEP holder for the record. Additionally, the data presented in the Labetalol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Labetalol Hydrochloride DMF.

A Labetalol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Labetalol Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Labetalol Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Labetalol Hydrochloride WC

A Labetalol Hydrochloride written confirmation (Labetalol Hydrochloride WC) is an official document issued by a regulatory agency to a Labetalol Hydrochloride manufacturer, verifying that the manufacturing facility of a Labetalol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Labetalol Hydrochloride APIs or Labetalol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Labetalol Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Labetalol Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Labetalol Hydrochloride NDC

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 Labetalol Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Labetalol Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Labetalol Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Labetalol Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Labetalol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Labetalol Hydrochloride suppliers with NDC on PharmaCompass.

Labetalol Hydrochloride GMP

Labetalol Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Labetalol Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Labetalol Hydrochloride GMP manufacturer or Labetalol Hydrochloride GMP API supplier for your needs.

Labetalol Hydrochloride CoA

A Labetalol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Labetalol Hydrochloride's compliance with Labetalol Hydrochloride specifications and serves as a tool for batch-level quality control.

Labetalol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Labetalol Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Labetalol Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Labetalol Hydrochloride EP), Labetalol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Labetalol Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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