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    Chemistry

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    Also known as: 19237-84-4, Prazosin hcl, Minipress, Vasoflex, Peripress, Furazosin hydrochloride
    Molecular Formula
    C19H22ClN5O4
    Molecular Weight
    419.9  g/mol
    InChI Key
    WFXFYZULCQKPIP-UHFFFAOYSA-N
    FDA UNII
    X0Z7454B90
    Prazosin Hydrochloride
    A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.
    1 2D Structure

    Prazosin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [4-(4-amino-6,7-dimethoxyquinazolin-2-yl)piperazin-1-yl]-(furan-2-yl)methanone;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H21N5O4.ClH/c1-26-15-10-12-13(11-16(15)27-2)21-19(22-17(12)20)24-7-5-23(6-8-24)18(25)14-4-3-9-28-14;/h3-4,9-11H,5-8H2,1-2H3,(H2,20,21,22);1H
    2.1.3 InChI Key
    WFXFYZULCQKPIP-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC1=C(C=C2C(=C1)C(=NC(=N2)N3CCN(CC3)C(=O)C4=CC=CO4)N)OC.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    X0Z7454B90
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Furazosin

    2. Hcl, Prazosin

    3. Hydrochloride, Prazosin

    4. Minipress

    5. Pratsiol

    6. Prazosin

    7. Prazosin Hcl

    2.3.2 Depositor-Supplied Synonyms

    1. 19237-84-4

    2. Prazosin Hcl

    3. Minipress

    4. Vasoflex

    5. Peripress

    6. Furazosin Hydrochloride

    7. Minipress Xl

    8. Hypovase

    9. 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furanylcarbonyl)piperazine Hydrochloride

    10. Cp-12299-1

    11. Prazosin (hydrochloride)

    12. 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl)piperazine Monohydrochloride

    13. Cp-12,299-1

    14. Prazosinhydrochloride

    15. (4-(4-amino-6,7-dimethoxyquinazolin-2-yl)piperazin-1-yl)(furan-2-yl)methanone Hydrochloride

    16. [4-(4-amino-6,7-dimethoxyquinazolin-2-yl)piperazin-1-yl]-(furan-2-yl)methanone;hydrochloride

    17. Mls000028454

    18. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furanylcarbonyl)-, Monohydrochloride

    19. Nsc-292810

    20. X0z7454b90

    21. Deprazolin

    22. Hypovasole

    23. Pratsiol

    24. Sinetens

    25. Smr000058384

    26. Minipress (tn)

    27. 19237-84-4 (hcl)

    28. 2-(4-(2-furoyl)piperazin-1-yl)-4-amino-6,7-dimethoxyquinazoline Hydrochloride

    29. 2-{4-[(furan-2-yl)carbonyl]piperazin-1-yl}-6,7-dimethoxyquinazolin-4-amine Hydrochloride

    30. Chebi:8365

    31. Hsdb 3298

    32. Methanone, [4-(4-amino-6,7-dimethoxy-2-quinazolinyl)-1-piperazinyl]-2-furanyl-, Hydrochloride (1:1)

    33. C19h21n5o4.hcl

    34. Nsc 292810

    35. Prazosin Clorhidrato [spanish]

    36. Prazosine Hydrochloride

    37. Sr-01000003052

    38. Einecs 242-903-4

    39. Mfcd00058177

    40. Unii-x0z7454b90

    41. Pressin And Hypovase

    42. Prazosin Hydrochloride [usan:usp:jan]

    43. Prazosin Hydrochloride;

    44. Opera_id_370

    45. Chembl1558

    46. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl)-, Monohydrochloride

    47. Schembl41257

    48. Mls001148201

    49. Mls001333696

    50. Mls002153280

    51. Mls002222304

    52. Spectrum1500495

    53. Prazosin Hcl (furazosin Hcl)

    54. Piperazin-1-yl)(furan-2-yl)

    55. Hy-b0193a

    56. Dtxsid50172822

    57. Hms1570n16

    58. Hms1920j10

    59. Pharmakon1600-01500495

    60. Prazosin Hydrochloride [mi]

    61. Bcp13643

    62. Prazosin Hydrochloride (jp17/usp)

    63. Prazosin Hydrochloride [jan]

    64. Tox21_501002

    65. Ac-699

    66. Ccg-39227

    67. Nsc292810

    68. Nsc757286

    69. Prazosin Hydrochloride [hsdb]

    70. Prazosin Hydrochloride [usan]

    71. S1424

    72. Prazosin Hydrochloride [vandf]

    73. Akos015895394

    74. Prazosin Hydrochloride [mart.]

    75. Af-0012

    76. H37p844

    77. Lp01002

    78. Nsc-757286

    79. Prazosin Hydrochloride [usp-rs]

    80. Prazosin Hydrochloride [who-dd]

    81. Sb17352

    82. Prazosin Hydrochloride, >=99% (tlc)

    83. Quinazoline, 4-amino-6,7-dimethoxy-2-(4-(2-furoyl)piperazin-1-yl)-, Hydrochloride

    84. Ncgc00094296-01

    85. Ncgc00094296-02

    86. Ncgc00094296-03

    87. Ncgc00094296-04

    88. Ncgc00094296-05

    89. Ncgc00261687-01

    90. Ba164294

    91. Db-044795

    92. Prazosin Hydrochloride [ep Impurity]

    93. Prazosin Hydrochloride [orange Book]

    94. Eu-0101002

    95. P0938

    96. Prazosin Hydrochloride [ep Monograph]

    97. Prazosin Hydrochloride [usp Monograph]

    98. D00609

    99. H11453

    100. Minizide Component Prazosin Hydrochloride

    101. Prazosin Hydrochloride 100 Microg/ml In Methanol

    102. Prazosin Hydrochloride Component Of Minizide

    103. Sr-01000003052-2

    104. Sr-01000003052-8

    105. W-107719

    106. Q27108060

    107. Piperazine,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl)-, Monohydrochloride

    108. Prazosin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    109. Prazosin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    110. 1-(4-amino-6,7-dimethoxy-2-quinazol Inyl)-4-(2-furanylcarbonyl)piperazine Hydrochloride

    111. Piperazine,7-dimethoxy-2-quinazolinyl)-4-(2-furanylcarbonyl)-, Monohydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 419.9 g/mol
    Molecular Formula C19H22ClN5O4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass419.1360319 g/mol
    Monoisotopic Mass419.1360319 g/mol
    Topological Polar Surface Area107 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity544
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    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 NamePrazosin hydrochloride
    Drug LabelPrazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Prazosin hydro...
    Active IngredientPrazosin hydrochloride
    Dosage FormCapsule
    Routeoral; Oral
    Strengtheq 5mg base; eq 2mg base; eq 1mg base
    Market StatusPrescription
    CompanyIvax Sub Teva Pharms; Teva Pharms; Mylan

    2 of 2  
    Drug NamePrazosin hydrochloride
    Drug LabelPrazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Prazosin hydro...
    Active IngredientPrazosin hydrochloride
    Dosage FormCapsule
    Routeoral; Oral
    Strengtheq 5mg base; eq 2mg base; eq 1mg base
    Market StatusPrescription
    CompanyIvax Sub Teva Pharms; Teva Pharms; Mylan

    4.2 Therapeutic Uses

    Adrenergic alpha-Antagonists; Antihypertensive Agents; Sympatholytics

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

    Prazosin hydrochloride is used in the management of hypertension. Prazosin's efficacy in hypertensive patients is similar to that of thiazide diuretics, beta-adrenergic blocking agents, hydralazine, and centrally acting adrenergic inhibitors (eg, clonidine, methyldopa). ... Prazosin has been shown to be effective in the management of hypertension in patients undergoing chronic hemodialysis, and the drug may be particularly useful in the acute management of severe hypertension in patients with increased concentrations of circulating catecholamines.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1860

    Prazosin has been used with good results alone or in combination with a beta-adrenergic blocking agent for the preoperative management of the signs and symptoms of pheochromocytoma in a limited number of patients; however, these patients may be particularly susceptible to a marked hypotensive response to the initial dose of prazosin. Limited data also suggest that prazosin may be useful for the treatment of Raynaud's disease or phenomenon and ergotamine induced peripheral ischemia.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1861

    Prazosin may be used as an adjunct to digoxin and diuretics for the treatment of congestive heart failure. However, prazosin has not been shown to improve survival in these patients. /NOT included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2430

    For more Therapeutic Uses (Complete) data for PRAZOSIN HYDROCHLORIDE (11 total), please visit the HSDB record page.

    4.3 Drug Warning

    May cause syncope with sudden loss of consciousness, usually attributable to an excessive postural hypotensive effect; risk may be reduced by limiting the initial dose of the drug to 1 mg, and by subsequently increasing the dosage slowly. Adverse reactions include dizziness, drowsiness, and other CNS effects; patients should be cautioned regarding activities such as driving and operating machinery, as well as interactions with other CNS acting drugs including alcohol. Other adverse reactions include palpitations and nausea. The concurrent use of a beta-adrenergic blocking agent may increase the risk of hypotension. /Prazosin hydrochloride/

    Hussar, D.A. (ed.). Modell's Drugs in Current Use and New Drugs. 38th ed. New York, NY: Springer Publishing Co., 1992., p. 135

    When prazosin is used as a fixed-combination preparation that includes polythiazide, the cautions, precautions, and contraindications associated with thiazide diuretics must be considered in addition to those associated with prazosin.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1862

    Caution should be used when adding prazosin to a preexisting antihypertensive regimen or when adding other hypotensive agents to a prazosin regimen in order to avoid a possible rapid fall in blood pressure. Caution should be used when administering prazosin to patients with chronic renal failure as they may require only small doses of the drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1862

    Prazosin has been used alone or in combination with other hypotensive agents for the management of severe hypertension in a limited number of pregnant women without apparent adverse effect on the fetus. There are no adequate and well controlled studies to date using prazosin in pregnant women, however, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1862

    For more Drug Warnings (Complete) data for PRAZOSIN HYDROCHLORIDE (18 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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
    alpha-Adrenergic Blocker [EPC]; Adrenergic alpha-Antagonists [MoA]
    5.3 Absorption, Distribution and Excretion

    There is intraindividual and interindividual variation in the rate of absorption and plasma concentrations of prazosin. The absolute oral bioavailability of prazosin is also variable but is reported to average about 60% (range: 43-82%). Results of one study indicate that the presence of food may delay absorption of the drug in some patients, but does not affect the extent of absorption.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    Following oral administration of prazosin hydrochloride, plasma concentrations of the drug reach a peak in 2-3 hrs in most fasting patients. Plasma concentrations of prazosin generally do not correlate with therapeutic effect. One manufacturer reports that plasma concentrations of the drug after a single 5 mg dose range from 0.01-0.075 ug/ml. Blood pressure begins to decrease within 2 hr after an oral dose; the maximum decrease occurs in 2-4 hr. The hypotensive effect of prazosin lasts less than 24 hr.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    Animal studies indicate that prazosin is widely distributed in body tissues. After iv administration in dogs, highest concentrations of the drug are found in the lungs, coronary arteries, aorta, paw arteries and heart; the lowest concentrations are in the brain. During prazosin therapy, approximately 97% of the drug in plasma is bound to proteins. It is not known whether the drug crosses the placenta. Prazosin is distributed into milk in small amounts.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    Approximately 6-10% of a dose is excreted in urine and the remainder in feces via bile.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    The drug /prazosin hydrochloride/ is tightly bound to plasma proteins (primarily alpha1-acid glycoprotein), and only 5% of the drug is free in the circulation; diseases that modify the concentration of this protein (e.g., inflammatory processes) may change the free fraction. Prazosin is extensively metabolized in the liver, and little unchanged drug is excreted by the kidneys.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 246

    5.4 Metabolism/Metabolites

    Animal studies show that prazosin hydrochloride is metabolized extensively in the liver, principally by demethylation and conjugation, and excreted as unchanged drug (5-11%) and metabolites. Four of the metabolites have been shown to possess 10-25% of the hypotensive activity of prazosin and they may contribute to the antihypertensive effect of the drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    The 6-O-demethyl and 7-O-demethyl analogues of the new antihypertensive drug prazosin [2-[4-(2-furoyl)-piperazin-1-yl]-4-amino-6,7-dimethoxyquinazoline hydrochloride] have been unequivocally synthesized via separate 10-step reaction sequences starting from isovanillin and vanillin, respectively. The 6-O-demethyl derivative was found to be identical with the major prazosin metabolite formed in dog and rat, while the 7-O-demethyl derivative was identical with another, less prevalent but significant metabolite. Two minor metabolites of prazosin, 2-(1-piperazinyl)-4-amino-6,7-dimethoxyquinazoline and 2,4-diamino-6,7-dimethoxyquinazoline, are also described. All 4 metabolites are less potent blood pressure lowering agents in dogs than prazosin but may contribute to its antihypertensive effect, since they account for a major portion of the administered dose.

    PMID:833813 Althius T, Hess H; J Med Chem 20 (1): 146-9 (1977)

    5.5 Biological Half-Life

    Elimination half-life approx 3 hr.

    Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 1348

    The plasma half-life of prazosin after oral administration has been reported to be 2-4 hr.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1863

    5.6 Mechanism of Action

    Animal studies indicate that prazosin does not have its antihypertensive effect in the CNS. Prazosin does not interfere with nerve impulse transmission across sympathetic ganglia nor does it cause adrenergic neuronal blockade.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 1862

    The exact mechanism of the hypotensive action of prazosin is unknown. Prazosin causes a decrease in total peripheral resistance and was originally thought to have a direct relaxant action on vascular smooth muscle. Animal studies have suggested that the vasodilator effect of prazosin is also related to blockade of postsynaptic alpha-adrenoceptors. The results of dog forelimb experiments demonstrate that that the peripheral vasodilator effect of prazosin is confined mainly to the level of the resistance vessels (arterioles). Unlike conventional alpha- blockers, the antihypertensive action of prazosin is usually not accompanied by reflex tachycardia.

    Medical Economics Co; Physicians Desk Reference 56th ed p. 2699 (2002)

    Prazosin ... is a very potent and selective alpha 1-adrenergic antagonist. ... Interestingly, the drug also is a relatively potent inhibitor of cyclic nucleotide phosphodiesterases...

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 246

    API Reference Price

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    DOSAGE - CAPSULE;ORAL - EQ 1MG BASE

    USFDA APPLICATION NUMBER - 17442

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    USFDA APPLICATION NUMBER - 17442

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    ABOUT THIS PAGE

    Looking for 19237-84-4 / Prazosin Hydrochloride API manufacturers, exporters & distributors?

    Prazosin Hydrochloride manufacturers, exporters & distributors 1

    13

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

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

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

    API | Excipient name

    Prazosin Hydrochloride

    Synonyms

    19237-84-4, Prazosin hcl, Minipress, Vasoflex, Peripress, Furazosin hydrochloride

    Cas Number

    19237-84-4

    Unique Ingredient Identifier (UNII)

    X0Z7454B90

    About Prazosin Hydrochloride

    A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.

    Vasoflex Manufacturers

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

    Vasoflex Suppliers

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

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

    Vasoflex USDMF

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

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

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

    Vasoflex CEP

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

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

    Vasoflex WC

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

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

    Vasoflex 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 Vasoflex as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Vasoflex GMP

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

    Vasoflex CoA

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

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

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