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    Chemistry

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    Also known as: 34381-68-5, Acebutolol hcl, Prent, Sectral, Neptal, Acebutolol (hydrochloride)
    Molecular Formula
    C18H29ClN2O4
    Molecular Weight
    372.9  g/mol
    InChI Key
    KTUFKADDDORSSI-UHFFFAOYSA-N
    FDA UNII
    B025Y34C54
    Acebutolol Hydrochloride
    A cardioselective beta-1 adrenergic antagonist with little effect on the bronchial receptors. The drug has stabilizing and quinidine-like effects on cardiac rhythm, as well as weak inherent sympathomimetic action.
    1 2D Structure

    Acebutolol Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]butanamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C18H28N2O4.ClH/c1-5-6-18(23)20-14-7-8-17(16(9-14)13(4)21)24-11-15(22)10-19-12(2)3;/h7-9,12,15,19,22H,5-6,10-11H2,1-4H3,(H,20,23);1H
    2.1.3 InChI Key
    KTUFKADDDORSSI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCC(=O)NC1=CC(=C(C=C1)OCC(CNC(C)C)O)C(=O)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    B025Y34C54
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acebutolol

    2. Acetobutolol

    3. Apo Acebutolol

    4. Apo-acebutolol

    5. Apoacebutolol

    6. M And B 17803 A

    7. M And B 17803a

    8. M And B-17803 A

    9. M And B17803 A

    10. Monitan

    11. Neptal

    12. Novo Acebutolol

    13. Novo-acebutolol

    14. Novoacebutolol

    15. Prent

    16. Rhotral

    17. Sectral

    2.3.2 Depositor-Supplied Synonyms

    1. 34381-68-5

    2. Acebutolol Hcl

    3. Prent

    4. Sectral

    5. Neptal

    6. Acebutolol (hydrochloride)

    7. Acetanol

    8. N-(3-acetyl-4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)butyramide Hydrochloride

    9. Il-17803a

    10. M&b 17803a

    11. Nsc-757412

    12. Mls000069553

    13. N-[3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]butanamide;hydrochloride

    14. Chebi:2380

    15. 3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide Hydrochloride

    16. Dl-1-(2-acetyl-4-butyramidophenoxy)-2-hydroxy-3-isopropylaminopropane Hydrochloride

    17. B025y34c54

    18. M&b-17803a

    19. B 17803a

    20. B-17803a

    21. Smr000058800

    22. (+-)-3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide Monohydrochloride

    23. Dsstox_cid_25461

    24. Dsstox_rid_80892

    25. N-(3-acetyl-4-{2-hydroxy-3-[(propan-2-yl)amino]propoxy}phenyl)butanamide Hydrochloride

    26. N-{3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl}butanamide Hydrochloride

    27. Dsstox_gsid_45461

    28. Diasectral

    29. Wesfalin

    30. N-[3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]butanamide Hydrochloride

    31. Acebutolol Hydrochloride [jan]

    32. Ccris 1102

    33. Sr-01000000133

    34. Unii-b025y34c54

    35. Hsdb 6524

    36. Prestwick_512

    37. Acebutolol Hydrochloride [usp:jan]

    38. Einecs 251-980-3

    39. Sectral (tn)

    40. Il 17803a

    41. M&b 17,803a

    42. Opera_id_1259

    43. Ncgc00016827-01

    44. Cas-34381-68-5

    45. Schembl41004

    46. Mls001076107

    47. Mls002222219

    48. Mls002548874

    49. Spectrum1500665

    50. (+/-)-acebutolol Hydrochloride

    51. Chembl1200813

    52. Dtxsid5045461

    53. Hms1568m19

    54. Hms1921a06

    55. Pharmakon1600-01500665

    56. Bcp28416

    57. Tox21_110633

    58. Ac-002

    59. Acebutolol Hydrochloride [mi]

    60. Ccg-39278

    61. Hy-17497a

    62. Mfcd00078860

    63. Nsc757412

    64. S4010

    65. Acebutolol Hydrochloride (jp17/usp)

    66. Akos015895193

    67. Tox21_110633_1

    68. Ab03018

    69. Acebutolol Hydrochloride [hsdb]

    70. Ks-5245

    71. Nc00669

    72. Nsc 757412

    73. Acebutolol Hydrochloride [mart.]

    74. Acebutolol Hydrochloride [vandf]

    75. S11992

    76. Acebutolol Hydrochloride [usp-rs]

    77. Acebutolol Hydrochloride [who-dd]

    78. Ncgc00018215-06

    79. Ncgc00094830-01

    80. Ncgc00094830-02

    81. Ncgc00094830-03

    82. Ncgc00094830-04

    83. Db-048610

    84. Acebutolol Hydrochloride, Analytical Standard

    85. Ft-0630582

    86. Sw196705-3

    87. Acebutolol Hydrochloride [ep Impurity]

    88. Acebutolol Hydrochloride [orange Book]

    89. Acebutolol Hydrochloride [ep Monograph]

    90. Acebutolol Hydrochloride [usp Impurity]

    91. Acebutolol Hydrochloride [usp Monograph]

    92. C07677

    93. D00597

    94. 381a685

    95. A822205

    96. J-019577

    97. Sr-01000000133-3

    98. Q27105651

    99. Acebutolol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    100. Acebutolol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    101. Acebutolol Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    102. Acebutolol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    103. Dl-1-(2-acetyl-4-butyramido)-3-(isopropylamino)propan-2-ol Hydrochloride

    104. (+/-)-3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide Monohydrochloride

    105. (1)-n-(3-acetyl-4-(2-hydroxy-3-((isopropyl)amino)propoxy)phenyl)butyramide Monohydrochloride

    106. Butanamide, N-(3-acetyl-4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)phenyl)-, Monohydrochloride, (+-)-

    107. Butanamide, N-(3-acetyl-4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)phenyl)-, Monohydrochloride, (+/-)-

    108. Butanamide, N-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]-, Hydrochloride (1:1)

    109. Butyranilide, 3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)-, Monohydrochloride, (+-)-

    110. N-(3-acetyl-4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)phenyl)-, Monohydrochloride, (+/-)-

    111. N-[3-acetyl-4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl]butanamide Hydrochloride;acebutolol Hydrochloride

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 372.9 g/mol
    Molecular Formula C18H29ClN2O4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count10
    Exact Mass372.1815851 g/mol
    Monoisotopic Mass372.1815851 g/mol
    Topological Polar Surface Area87.7 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity401
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameAcebutolol hydrochloride
    Drug LabelAcebutolol HCl is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administrat...
    Active IngredientAcebutolol hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 200mg base; eq 400mg base
    Market StatusPrescription
    CompanyAmneal Pharm; Mylan

    2 of 2  
    Drug NameAcebutolol hydrochloride
    Drug LabelAcebutolol HCl is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administrat...
    Active IngredientAcebutolol hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 200mg base; eq 400mg base
    Market StatusPrescription
    CompanyAmneal Pharm; Mylan

    4.2 Therapeutic Uses

    Adrenergic beta-Antagonists; Anti-Arrhythmia Agents; Antihypertensive Agents; Sympatholytics

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Acebutolol ... /is/ indicated in the treatment of classic angina pectoris, also referred to as "effort-associated angina". /NOT included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 550

    Acebutolol /is/ used in the treatment of mitral value prolapse syndrome. /NOT included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 551

    Acebutolol ... /is/ used for thyrotoxicosis. /NOT included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 551

    For more Therapeutic Uses (Complete) data for ACEBUTOLOL HYDROCHLORIDE (10 total), please visit the HSDB record page.

    4.3 Drug Warning

    Abrupt withdrawal of acebutolol may exacerbate angina symptoms or precipitate myocardial infarction in patients with corornary artery disease. Therefore, patients receiving acebutolol (especially those with ischemic heart disease) should be warned not to interrupt or discontinue therapy without consulting their physician. When acebutolol therapy is discontinued, patients should be monitored carefully and advised to temporarily limit their physical activity. If exacerbation of angina occurs after acebutolol therapy is interrupted, antianginal therapy should be reinstituted promptly, and appropriate measures for the management of unstable angina pectoris should be initiated. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue acebutolol therapy abruptly, even in patients receiving the drug for conditions other than angina.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1733

    Since beta-adrenergic blocking agents may reduce cardiac output and precipitate or aggravate the symptoms of arterial insufficiency in patients with peripheral or mesenteric vascular disease, acebutolol should be used with caution in these patients, and the patients should be observed for evidence of progression of arterial insufficiency.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1733

    ... It is recommended that acebutolol be used with caution in patients with diabetes mellitus (especially those with labile diabetes) since the drug also may mask signs and symptoms of hypoglycemia (e.g., tachycardia, palpitation, blood pressure changes, tremor, feelings of anxiety, but not sweating) and may potentiate insulin-induced hypoglycemia.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1734

    Since beta-adrenergic blocking agents may inhibit bronchodilation produced by endogenous catecholamines, the drugs generally should not be used in patients with bronchospastic disease; however, because of its relative beta 1-selective adrenergic blocking activity, acebutolol may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate other hypotensive agents.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1734

    For more Drug Warnings (Complete) data for ACEBUTOLOL HYDROCHLORIDE (22 total), please visit the HSDB record page.

    4.4 Minimum/Potential Fatal Human Dose

    Death occurred after an 8.8 g overdose, whereas survival occurred with 7.6 and 9.6 g overdoses.

    Ellenhorn, M.J. and D.G. Barceloux. Medical Toxicology - Diagnosis and Treatment of Human Poisoning. New York, NY: Elsevier Science Publishing Co., Inc. 1988., p. 189

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    Adrenergic beta-1 Receptor Antagonists

    Drugs that bind to and block the activation of ADRENERGIC BETA-1 RECEPTORS. (See all compounds classified as Adrenergic beta-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.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]
    5.3 Absorption, Distribution and Excretion

    Distribution of acebutolol hydrochloride into body tissue and fluids has not been fully characterized. Following IV administration in rats, acebutolol is distributed extensively into many tissues, including heart, liver, kidneys, lungs, intestines, stomach, and salivary glands, but only minimally into CSF or testes. Following oral administration of acebutolol hydrochloride in healthy individuals, acebutolol and, to a lesser extent, diacetolol, are distributed into saliva and minimally into CSF. Following oral administration of a single 300-mg dose of acebutolol hydrochloride, about 3-9% of the dose is distributed into bile within 24 hours, in approximately equivalent amounts as acebutolol and diacetolol. Peak biliary concentrations of acebutolol are approximately 60-100 times greater than peak plasma concentrations.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    Acebutolol and diacetolol readily cross the placenta and can accumulate in the fetus. In pregnant women receiving acebutolol, the mean acebutolol and diacetolol ratios of umbilical venous to maternal venous plasma concentrations were 0.8 (range: 0.5-1) and 0.6 (range: 0.3-0.8), respectively.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    Following IV administration, acebutolol is rapidly and widely distributed into the extravascular space and the apparent volume of distribution of the drug in healthy adults is approximately 1.6-3 l/kg (range: 1-3.8 l/kg). In healthy individuals, the volume of distribution in the central compartment and at steady state averages 0.16-0.22 and approximately 1.2 l/kg, respectively, following IV administration. The apparent volume distribution may be decreased in geriatric patients.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    In vitro, acebutolol and diacetolol are approximately 11-35 and 6-9% bound, respectively, to plasma proteins at plasma acebutolol concentrations of 20-9,000 ng/ml. Acebutolol is approximately 50% bound to erythrocytes.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    For more Absorption, Distribution and Excretion (Complete) data for ACEBUTOLOL HYDROCHLORIDE (16 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    Acebutolol is rapidly and extensively metabolized in the liver. Acebutolol undergoes extensive hydrolysis of the butyramide group to form the desbutyl primary amine, acetolol, which is almost completely converted via N-acetylation to diacetolol. The extent of metabolism of acebutolol to diacetolol appears to be independent of the genetic acetylator phenotype of the patient. Diacetolol is equipotent to acebutolol and has a similar pharmacologic profile.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    5.5 Biological Half-Life

    Following single or mutiple oral doses of acebutolol hydrochloride, the elimination half-life of diacetolol reportedly averages 21.5 hours (range: 11-49 hours) or 32 hours (range: 17-54 hours) in patients with creatinine clearances of 6-56 or less than 5 ml/minute, respectively.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    Following a single oral dose in healthy adults, the half-life of acebutolol in the initial distrubution phase (t1/2 alpha) is about 3 hours and the half-life in the terminal phase (t1/2 beta) has been reported to average 11 hours (range: 6-12 hours). The half-lives of the two identified metabolites, diacetolol and acetolol, average 7.5 (range: 7-11 hours) and 3 hours, respectively, following a single oral dose of the drug. The half-life of acebutolol tends to be slightly prolonged following multiple rather than single doses. Following multiple-dose oral administration of acebutolol hyrochloride in healthy individuals (400 mg twice daily for 56 days), the elimination half-life of acebutolol average 13 hours (range: 9-20 hours). The elimination half-lives of acebutolol and diacetolol may be slightly iincreased in geriatric patients.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    The plasma elimination half-lives of acebutolol and diacetolol in neonates born to women receiving the drug during pregnancy ranged from 6-14 and from 24-30 hours, respectively, in the first 24 hours after birth; the half-life of diacetolol decreased to 12-16 hours during the second day. Neonatal urinary excretion of the drug and diacetolol was maximal during the first 24 hours after birth.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1736

    5.6 Mechanism of Action

    Acebutolol is a beta-selective adrenergic blocking agent and has pharmacologic actions similar to those of other beta-adrenergic blocking agents. At low dosages, acebutolol selectively inhibits response to adrenergic stimuli by competively blocking cardiac beta1-adrenergic receptors, while having little effect on the beta2-adrenergic receptors of bronchial and vascular smooth muscle. At high dosages (eg, greater than 80 mg daily), the selectively of acebutolol for beta-1-adrenergic receptors usually diminishes, and the drug will competively inhibit beta-1- and beta-2-adrenergic receptors. The beta1-selective blocking activity of acebutolol appears to be more pronounced in animals than in humans. In vivo studies in animals and humans indicate that the relative beta-1-adrenergic blocking activity of acebutolol, on a weight basis, is approximately 10-30% that of propranolol, as determined by inhibition of reflex tachycardia in animals or inhibition of exercise or tilt-induced or reflex tachycardia in healthy individuals.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1735

    In addition to inhibiting access of physiologic or synthetic catecholamines to beta-adrenergic receptors, acebutolol exhibits mild intrinsic sympathomimetic activity (partial beta-agonist activity). Acebutolol also has a membrane-stabilizing effect on the heart, which is similar to that of quinidine but occurs only at high plasma concentrations and usually is not apparent at dosages used clinically.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1735

    The pharmacologic effects of acebutolol results from both the unchanged drug and its major metabolite, diacetolol. Diacetolol is equipotent to acebutolol and, in animals, has greater beta-selective adrenergic blocking activity than the parent drug. Diacetolol also has weak intrinsic sympathomimetic activity but does not have substantial membrane-stabilizing activity. Diacetolol may contribute substantially to the observed effects of acebutolol, since plasma concentrations of the metabolite are consistently higher than those of the parent during acebutolol therapy.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1735

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    [{"dataSource":"API Import","activeIngredients":"ACEBUTOLOL HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1614191400,"product":"ACEBUTOLOL HYDROCHLORIDE PH.EUR","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"243.57","actualQuantity":"243.57","unit":"KGS","unitRateFc":"58","totalValueFC":"17317.6","currency":"EUR","unitRateINR":"5176.5","date":"25-Feb-2021","totalValueINR":"1260840.11","totalValueInUsd":"17317.6","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"2914106","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"ACEBUTOLOL HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1621535400,"product":"ACEBUTOLOL HYDROCHLORIDE PH.EUR","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"513.46","actualQuantity":"513.46","unit":"KGS","unitRateFc":"58","totalValueFC":"36916.2","currency":"EUR","unitRateINR":"5266.4","date":"21-May-2021","totalValueINR":"2704085.74","totalValueInUsd":"36916.2","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"4023991","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643999400,"product":"ACEBUTOLOL HCL PH.EUR ( PHARMACEUTICAL PRODUCT)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MYLAN DUBLIN A DIVISION OF MCDERMOTT LABORATORIE","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"VIATRIS","customerCountry":"INDIA","quantity":"1199.00","actualQuantity":"1199","unit":"KGS","unitRateFc":"67.7","totalValueFC":"81997.9","currency":"USD","unitRateINR":"5126.2","date":"05-Feb-2022","totalValueINR":"6146310","totalValueInUsd":"81997.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"1000801","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"N\/A","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646332200,"product":"ACEBUTOLOL HYDROCHLORIDE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"MOEHS CANTABRA S.L.","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"94","totalValueFC":"189061.8","currency":"USD","unitRateINR":"7205.1","date":"04-Mar-2022","totalValueINR":"14410200","totalValueInUsd":"189061.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242990","bill_no":"1000890","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659119400,"product":"ACEBUTOLOL HYDROCHLORIDE PH EUR","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"M\/S. 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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1680201000,"product":"ACEBUTOLOL HYDROCHLORIDE PH.EUR","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1102.90","actualQuantity":"1102.9","unit":"KGS","unitRateFc":"84","totalValueFC":"104511.8","currency":"EUR","unitRateINR":"7794.1","date":"31-Mar-2023","totalValueINR":"8596131.01","totalValueInUsd":"104511.8","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"5313801","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689791400,"product":"ACEBUTOLOL HYDROCHLORIDE PH.EUR","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"650.00","actualQuantity":"650","unit":"KGS","unitRateFc":"84","totalValueFC":"62479.5","currency":"EUR","unitRateINR":"7900.2","date":"20-Jul-2023","totalValueINR":"5135160.947","totalValueInUsd":"62479.5","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700245800,"product":"ACEBUTOLOL HYDROCHLORIDE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"2101.00","actualQuantity":"2101","unit":"KGS","unitRateFc":"93.5","totalValueFC":"198371.1","currency":"USD","unitRateINR":"7862.2","date":"18-Nov-2023","totalValueINR":"16518538","totalValueInUsd":"198371.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"1007513","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C PABLO PICASSO,1508213 POLINYABARCELONA, SPAIN","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710095400,"product":"ACEBUTOLOL HYDROCHLORIDE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"MOEHS CANTABRA S ","supplierCountry":"SPAIN","foreign_port":"BILBAO","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"92.3","totalValueFC":"12258.4","currency":"EUR","unitRateINR":"8482.4","date":"11-Mar-2024","totalValueINR":"1017884.4","totalValueInUsd":"12258.4","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"2517930","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BILBAO","supplierAddress":"POLIGONO IND. 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    25-Feb-2021
    11-Mar-2024
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    ABOUT THIS PAGE

    Acebutolol Hydrochloride Manufacturers

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

    Acebutolol Hydrochloride Suppliers

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

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

    Acebutolol Hydrochloride USDMF

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

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

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

    Acebutolol Hydrochloride CEP

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

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

    Acebutolol Hydrochloride WC

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

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

    Acebutolol 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 Acebutolol Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Acebutolol Hydrochloride GMP

    Acebutolol 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 Acebutolol 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 Acebutolol Hydrochloride GMP manufacturer or Acebutolol Hydrochloride GMP API supplier for your needs.

    Acebutolol Hydrochloride CoA

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

    Acebutolol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Acebutolol 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.

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