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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]

    API Reference Price

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ITALY IT","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751481000,"product":"LABETALOL HYDROCHLORIDE USP LABETALOL HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"PROCOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN - LINATE","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"5.47","actualQuantity":"5.47","unit":"KGS","unitRateFc":"800","totalValueFC":"4456.5","currency":"USD","unitRateINR":"70120","date":"03-Jul-2025","totalValueINR":"383556.4","totalValueInUsd":"4456.5","indian_port":"Madras Air","hs_no":"29242990","bill_no":"3034210","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - LINATE","supplierAddress":"Via Matteotti 249 28062 Cameri (NO) ITALY IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751567400,"product":"SD62001 LABETALOL HYDROCHLORIDE","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"ALIVUS LIFE SCIENCES LTD.","supplierCountry":"INDIA","foreign_port":"DAHEJ","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"148.9","totalValueFC":"1491.7","currency":"USD","unitRateINR":"12838.5","date":"04-Jul-2025","totalValueINR":"128385","totalValueInUsd":"1491.7","indian_port":"Dahez-SEZ","hs_no":"29420090","bill_no":"3051619","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DAHEJ","supplierAddress":"Plot No. Z\/103\/I, SEZ Phase-II Dahej, Taluka Dist. Bharuch SDNF India","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753727400,"product":"LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"PROCOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN - LINATE","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"11.81","actualQuantity":"11.81","unit":"KGS","unitRateFc":"800","totalValueFC":"9528.6","currency":"USD","unitRateINR":"69440","date":"29-Jul-2025","totalValueINR":"820086.4","totalValueInUsd":"9528.6","indian_port":"Madras Air","hs_no":"29242990","bill_no":"3560456","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - LINATE","supplierAddress":"Via Matteotti 249 28062 Cameri (NO) ITALY IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753727400,"product":"LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"PROCOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN - LINATE","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"22.94","actualQuantity":"22.94","unit":"KGS","unitRateFc":"800","totalValueFC":"18508.5","currency":"USD","unitRateINR":"69440","date":"29-Jul-2025","totalValueINR":"1592953.6","totalValueInUsd":"18508.5","indian_port":"Madras Air","hs_no":"29242990","bill_no":"3560456","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - LINATE","supplierAddress":"Via Matteotti 249 28062 Cameri (NO) ITALY IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"}]
    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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