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    Also known as: 81403-68-1, Alfuzosin hcl, Uroxatral, Urion, Xatral, Alfoten
    Molecular Formula
    C19H28ClN5O4
    Molecular Weight
    425.9  g/mol
    InChI Key
    YTNKWDJILNVLGX-UHFFFAOYSA-N
    FDA UNII
    75046A1XTN
    Alfuzosin HCl
    Alfuzosin Hydrochloride is the hydrochloride salt of alfuzosin, a quinazoline compound with smooth muscle-relaxing activity. Alfuzosin selectively binds to and antagonizes post-synaptic alpha-1-adrenoreceptors in smooth muscle of the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra, initiating relaxation of smooth muscle and resulting in improvement of urine flow and the symptoms of benign prostatic hyperplasia (BPH). This agent also blocks alpha-1-adrenoreceptors in peripheral vascular smooth muscle, resulting in vasodilatation and a decrease in peripheral vascular resistance.
    1 2D Structure

    Alfuzosin HCl

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)-methylamino]propyl]oxolane-2-carboxamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H27N5O4.ClH/c1-24(8-5-7-21-18(25)14-6-4-9-28-14)19-22-13-11-16(27-3)15(26-2)10-12(13)17(20)23-19;/h10-11,14H,4-9H2,1-3H3,(H,21,25)(H2,20,22,23);1H
    2.1.3 InChI Key
    YTNKWDJILNVLGX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(CCCNC(=O)C1CCCO1)C2=NC3=CC(=C(C=C3C(=N2)N)OC)OC.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    75046A1XTN
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Alfetim

    2. Alfusozine

    3. Alfuzosin

    4. Alphuzosine

    5. Benestan

    6. N-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-2-furancarboxamide

    7. Urion

    8. Uroxatral

    9. Xatral

    2.3.2 Depositor-Supplied Synonyms

    1. 81403-68-1

    2. Alfuzosin Hcl

    3. Uroxatral

    4. Urion

    5. Xatral

    6. Alfoten

    7. Alfuzosin (hydrochloride)

    8. Sl 77 499-10

    9. Sl 77499-10

    10. Alfuzosinhydrochloride

    11. Sl-77499-10

    12. 75046a1xtn

    13. Alfuzosin Hydrochloride (uroxatral)

    14. Alfetim

    15. Sl-77-499-10

    16. Dsstox_cid_25514

    17. Dsstox_rid_80924

    18. Dsstox_gsid_45514

    19. N-(3-((4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino)propyl)tetrahydrofuran-2-carboxamide Hydrochloride

    20. N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)-methylamino]propyl]oxolane-2-carboxamide;hydrochloride

    21. Sl-7749910

    22. 81403-68-1 (alfuzosin Hcl), 81403-80-7(alfuzosin).

    23. Alfuzosin Hydrochloride [usan]

    24. Xatral Retard

    25. Xatral Od

    26. Xatral Sr

    27. Xatral Xl

    28. Chebi:32286

    29. Uroxatral (tn)

    30. N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furancarboxamide, Monohydrochloride

    31. Unii-75046a1xtn

    32. N-(3-((4-amino-6,7-dimethoxyquinazolin-2-yl)

    33. Sr-01000759345

    34. Alfuzosin Hydrochloride (jan/usan)

    35. Alfuzosin Hydrochloride [usan:usp]

    36. Mfcd00879135

    37. Sl-77499

    38. Alfuzosin Hydrochloride;

    39. Ncgc00016946-01

    40. Sl77.0499-10

    41. Cas-81403-68-1

    42. Sl-77.0499-10

    43. Alfuzosin Hydrochloride,(s)

    44. Chembl1723

    45. Alfuzosin-[d3] Hydrochloride

    46. Schembl179910

    47. Dtxsid3045514

    48. Alfuzosin For Peak Identification

    49. Hy-b0192a

    50. Alfuzosin For System Suitability A

    51. Bcpp000417

    52. Hms1569a05

    53. Alfuzosin Hydrochloride [mi]

    54. Tox21_110701

    55. Tox21_500224

    56. Alfuzosin Hydrochloride [jan]

    57. S1409

    58. (methyl)amino)propyl)tetrahydrofuran-2

    59. Akos015966770

    60. Tox21_110701_1

    61. Ac-1116

    62. Alfuzosin Hydrochloride [mart.]

    63. Bcp9000271

    64. Ccg-213373

    65. Lp00224

    66. Alfuzosin Hydrochloride [usp-rs]

    67. Alfuzosin Hydrochloride [who-dd]

    68. Ncgc00095152-09

    69. Ncgc00260909-01

    70. 2-furancarboxamide, N-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-, Monohydrochloride (+-)-

    71. As-14240

    72. Alfuzosin Hydrochloride [orange Book]

    73. Ft-0630890

    74. Sw196913-4

    75. Alfuzosin Hydrochloride [ep Monograph]

    76. Alfuzosin Hydrochloride [usp Monograph]

    77. D01692

    78. T71347

    79. Alfuzosin Hydrochloride, >=98% (hplc), Solid

    80. 403a681

    81. A840121

    82. Sr-01000759345-5

    83. Q27114856

    84. Alfuzosin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    85. Alfuzosin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    86. Alfuzosin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    87. Alfuzosin For System Suitability A, European Pharmacopoeia (ep) Reference Standard

    88. Alfuzosin For System Suitability, European Pharmacopoeia (ep) Reference Standard

    89. Alfuzosin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    90. (+/-)-n-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-2-furamide Monohydrochloride

    91. 2-furancarboxamide, (+/-)-n-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-, Monohydrochloride

    92. 4-amino-6,7-dimethoxy-2-[methyl[3-[(tetrahydro-2-furoyl)amino]propyl]amino]quinazoline Hydrochloride

    93. N-(3-((4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino)-propyl)tetrahydrofuran-2-carboxamide Hydrochloride

    94. N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)(methyl)amino]propyl]tetrahydro-2-furancarboxamide Hydrochloride

    95. N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furancarboxamide Hydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 425.9 g/mol
    Molecular Formula C19H28ClN5O4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count8
    Exact Mass425.1829821 g/mol
    Monoisotopic Mass425.1829821 g/mol
    Topological Polar Surface Area112 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity511
    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 4  
    Drug NameAlfuzosin hydrochloride
    Drug LabelEach alfuzosin hydrochloride extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white powder that melts at 231 to 233C. It is freely soluble in water, sparingly solub...
    Active IngredientAlfuzosin hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyWockhardt; Teva Pharms; Apotex; Aurobindo Pharma; Torrent Pharms; Invagen Pharms; Sun Pharma Global; Mylan

    2 of 4  
    Drug NameUroxatral
    PubMed HealthAlfuzosin (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelEach UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240C. It is freely soluble in water, sparingly so...
    Active IngredientAlfuzosin hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyCovis Pharma Sarl

    3 of 4  
    Drug NameAlfuzosin hydrochloride
    Drug LabelEach alfuzosin hydrochloride extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white powder that melts at 231 to 233C. It is freely soluble in water, sparingly solub...
    Active IngredientAlfuzosin hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyWockhardt; Teva Pharms; Apotex; Aurobindo Pharma; Torrent Pharms; Invagen Pharms; Sun Pharma Global; Mylan

    4 of 4  
    Drug NameUroxatral
    PubMed HealthAlfuzosin (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelEach UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240C. It is freely soluble in water, sparingly so...
    Active IngredientAlfuzosin hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyCovis Pharma Sarl

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    alpha-Adrenergic Blocker [EPC]; Adrenergic alpha-Antagonists [MoA]

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V. ROAD,JOGESHWA RI WEST","city":"MUMBAI","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE RUZYNE","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1050","totalValueFC":"53052.4","currency":"USD","unitRateINR":"87307.5","date":"04-May-2023","totalValueINR":"4365375","totalValueInUsd":"53052.4","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Czech Republic","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE RUZYNE","supplierAddress":"","customerAddress":"UNICHEM BHAVAN S. V. ROAD,JOGESHWA RI WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695234600,"product":"ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE IP)","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE - RUZYNE","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1050","totalValueFC":"106191.3","currency":"USD","unitRateINR":"88147.5","date":"21-Sep-2023","totalValueINR":"8814750","totalValueInUsd":"106191.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7934722","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"NA VLCINCI 16\/3 KLASTERNI HRADISKO779 0 0 OLOMOUC CZECH REPUBLIC , ,Czech Republic Czech Republic","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"ALFUZOSIN HYDROCHLORIDE (QTY: 2 X 150MG, VALUE USD: 374\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"USP","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0003","unit":"KGS","unitRateFc":"2493333.3","totalValueFC":"762.5","currency":"USD","unitRateINR":"213182966.7","date":"01-Aug-2024","totalValueINR":"63954.89","totalValueInUsd":"762.5","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4827338","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD 21704 USA Frederick, , United States United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE IP)","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"OSTRAVA","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1050","totalValueFC":"105903.1","currency":"USD","unitRateINR":"88830","date":"03-Aug-2024","totalValueINR":"8883000","totalValueInUsd":"105903.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4861593","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"OSTRAVA","supplierAddress":"NA VLCINCI 16\/3 KLASTERNI HRADISKO779 0 0 OLOMOUC CZECH REPUBLIC , ,Czech Republic Czech Republic","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"ALFUZOSIN HYDROCHLORIDE IP, CAS NO. 81403-68-1, BATCH NO.24080524,24100624,24110624,25010724,25020724,25030724,25040724","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"OSTRAVA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"950","totalValueFC":"192088.1","currency":"USD","unitRateINR":"80702.5","date":"26-Oct-2024","totalValueINR":"16140500","totalValueInUsd":"192088.1","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"6358659","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"OSTRAVA","supplierAddress":"NA VLCINCI 16\/3 KLATERNIHRADISKO 77 900 OLOMOUC SDNF CZECH REPUBLIC","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736879400,"product":"ALFUZOSIN HYDROCHLORIDE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAHA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"1030","totalValueFC":"124131.5","currency":"USD","unitRateINR":"89198","date":"15-Jan-2025","totalValueINR":"10703760","totalValueInUsd":"124131.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"7789769","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAHA","supplierAddress":"NA VLCINCI 16\/3 KLASTERNI HRADISKO OLOMOUC SDNF Czech Republic","customerAddress":"564\/A\/22, ROAD NO.92"}]
    05-Feb-2021
    25-Mar-2025
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    South Africa

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    01

    Sanofi Aventis South Africa (Pty) Ltd

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Originator

    Registration Country : South Africa

    Alfuzosin Hydrochloride

    Brand Name : Alfuwin XL

    Dosage Form : TAB

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Sanofi Aventis South Africa (Pty) Ltd

    France
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    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Originator

    Registration Country : South Africa

    Alfuzosin

    Brand Name : Xatral XL 10 mg

    Dosage Form : TAB

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Ranbaxy S.A (Pty) Ltd

    India
    Cophex
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    Ranbaxy S.A (Pty) Ltd

    India
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    Cophex
    Not Confirmed
    • fda
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alfuzosin

    Brand Name : Rantral MR 10

    Dosage Form : TAB

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    ABOUT THIS PAGE

    Looking for 81403-68-1 / Alfuzosin HCl API manufacturers, exporters & distributors?

    Alfuzosin HCl manufacturers, exporters & distributors 1

    51

    PharmaCompass offers a list of Alfuzosin HCl 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 Alfuzosin HCl manufacturer or Alfuzosin HCl supplier for your needs.

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

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

    API | Excipient name

    Alfuzosin HCl

    Synonyms

    81403-68-1, Uroxatral, Urion, Xatral, Alfoten, Alfuzosin (hydrochloride)

    Cas Number

    81403-68-1

    Unique Ingredient Identifier (UNII)

    75046A1XTN

    About Alfuzosin HCl

    Alfuzosin Hydrochloride is the hydrochloride salt of alfuzosin, a quinazoline compound with smooth muscle-relaxing activity. Alfuzosin selectively binds to and antagonizes post-synaptic alpha-1-adrenoreceptors in smooth muscle of the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra, initiating relaxation of smooth muscle and resulting in improvement of urine flow and the symptoms of benign prostatic hyperplasia (BPH). This agent also blocks alpha-1-adrenoreceptors in peripheral vascular smooth muscle, resulting in vasodilatation and a decrease in peripheral vascular resistance.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard Manufacturers

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

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard Suppliers

    A Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard supplier is an individual or a company that provides Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard active pharmaceutical ingredient (API) or Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard finished formulations upon request. The Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers may include Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard API manufacturers, exporters, distributors and traders.

    click here to find a list of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard USDMF

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

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

    click here to find a list of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with USDMF on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard Drug Master File in Korea (Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard. The MFDS reviews the Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard KDMF as part of the drug registration process and uses the information provided in the Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with KDMF on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard CEP

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

    A Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with CEP (COS) on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard WC

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

    click here to find a list of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with Written Confirmation (WC) on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard suppliers with NDC on PharmaCompass.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard GMP

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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 Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard GMP manufacturer or Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard GMP API supplier for your needs.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard CoA

    A Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard CoA (Certificate of Analysis) is a formal document that attests to Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard's compliance with Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard specifications and serves as a tool for batch-level quality control.

    Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard CoA mostly includes findings from lab analyses of a specific batch. For each Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard 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.

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