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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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ITALY IT","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"LABETALOL HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"PROCOS SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"31.00","actualQuantity":"31","unit":"KGS","unitRateFc":"825","totalValueFC":"25825.6","currency":"USD","unitRateINR":"70001.3","date":"14-Oct-2024","totalValueINR":"2170038.75","totalValueInUsd":"25825.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6108596","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA MATTEOTTI 249 28062 CAMERI (NO) - ITALY IT","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"LABETALOL HYDROCHLORIDE USP","address":"PLOT NO. 1175, AT POST DABHASA","city":"DIST. BARODA","supplier":"PROCOS SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ELYSIUM PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"202.00","actualQuantity":"202","unit":"KGS","unitRateFc":"195","totalValueFC":"39815.6","currency":"USD","unitRateINR":"16633.5","date":"19-Nov-2024","totalValueINR":"3359967","totalValueInUsd":"39815.6","indian_port":"Ahmedabad Air","hs_no":"29242990","bill_no":"6761097","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA MATTEOTTI, 249 28062 CAMERI NO ITALY Cameri, , Italy SDNF Italy","customerAddress":"PLOT NO. 1175, AT POST DABHASA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733682600,"product":"LABETALOL HCL PH.EUR","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"N\/A","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"578.00","actualQuantity":"578","unit":"KGS","unitRateFc":"317.9","totalValueFC":"185241.3","currency":"USD","unitRateINR":"27231.4","date":"09-Dec-2024","totalValueINR":"15739763","totalValueInUsd":"185241.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"7122619","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"N\/A","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736533800,"product":"LABETALOL HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"PROCOS SPA","supplierCountry":"ITALY","foreign_port":"LA SPEZIA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"2312.95","actualQuantity":"2312.95","unit":"KGS","unitRateFc":"187","totalValueFC":"434381.6","currency":"USD","unitRateINR":"16194.2","date":"11-Jan-2025","totalValueINR":"37456374.89","totalValueInUsd":"434381.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"7729995","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"LA SPEZIA","supplierAddress":"Via Matteotti, 249 Cameri (NO) SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737311400,"product":"LABETALOL HCL PH.EUR","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"DERIVADOS QUIMICOS SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"304.20","actualQuantity":"304.2","unit":"KGS","unitRateFc":"309.6","totalValueFC":"95145","currency":"USD","unitRateINR":"26970","date":"20-Jan-2025","totalValueINR":"8204274","totalValueInUsd":"95145","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"7886410","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"CAMINO DE PLIEGO N150 ALCANTARILLA MURCIA SDNF","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739471400,"product":"LABETALOL HYDROCHLORIDE USP LABETALOL HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"PROCOS SPA","supplierCountry":"ITALY","foreign_port":"MILAN - 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06-Jan-2022
02-Apr-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

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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 Manufacturers

A Labetalol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Labetalol, including repackagers and relabelers. The FDA regulates Labetalol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Labetalol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Labetalol Suppliers

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

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

Labetalol USDMF

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

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

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

Labetalol 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 Drug Master File in Japan (Labetalol JDMF) empowers Labetalol 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Labetalol 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 suppliers with JDMF on PharmaCompass.

Labetalol CEP

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

A Labetalol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Labetalol 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 suppliers with CEP (COS) on PharmaCompass.

Labetalol WC

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

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

Labetalol 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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Labetalol 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Labetalol NDC to their finished compounded human drug products, they may choose to do so.

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

Labetalol GMP

Labetalol 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 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 GMP manufacturer or Labetalol GMP API supplier for your needs.

Labetalol CoA

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

Labetalol CoA mostly includes findings from lab analyses of a specific batch. For each Labetalol 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Labetalol EP), Labetalol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Labetalol 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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