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    Chemistry

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    Also known as: 106463-17-6, Flomax, Tamsulosin hcl, Omnic, Pradif, Harnal
    Molecular Formula
    C20H29ClN2O5S
    Molecular Weight
    445.0  g/mol
    InChI Key
    ZZIZZTHXZRDOFM-XFULWGLBSA-N
    FDA UNII
    11SV1951MR
    Tamsulosin
    A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.
    1 2D Structure

    Tamsulosin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[(2R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C20H28N2O5S.ClH/c1-4-26-17-7-5-6-8-18(17)27-12-11-22-15(2)13-16-9-10-19(25-3)20(14-16)28(21,23)24;/h5-10,14-15,22H,4,11-13H2,1-3H3,(H2,21,23,24);1H/t15-;/m1./s1
    2.1.3 InChI Key
    ZZIZZTHXZRDOFM-XFULWGLBSA-N
    2.1.4 Canonical SMILES
    CCOC1=CC=CC=C1OCCNC(C)CC2=CC(=C(C=C2)OC)S(=O)(=O)N.Cl
    2.1.5 Isomeric SMILES
    CCOC1=CC=CC=C1OCCN[C@H](C)CC2=CC(=C(C=C2)OC)S(=O)(=O)N.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    11SV1951MR
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide

    2. Flomax

    3. Ly 253352

    4. Ly-253352

    5. Tamsulosin

    6. Ym 617

    7. Ym-617

    2.3.2 Depositor-Supplied Synonyms

    1. 106463-17-6

    2. Flomax

    3. Tamsulosin Hcl

    4. Omnic

    5. Pradif

    6. Harnal

    7. Urolosin

    8. Secotex

    9. Josir

    10. Alna

    11. Omic

    12. Omix

    13. Ym617

    14. Ly253351

    15. Amsulosin Hydrochloride

    16. Tamsulosin (hydrochloride)

    17. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

    18. R-(-)-ym-12617

    19. Ym 617

    20. Ym-12617-1

    21. Ym-617

    22. Ly-253351

    23. Chebi:9399

    24. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride

    25. 11sv1951mr

    26. 5-[(2r)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride

    27. 5-[(2r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide;hydrochloride

    28. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamide Hydrochloride

    29. R-(-)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

    30. Expros

    31. Flomax (tn)

    32. Dsstox_cid_26628

    33. Dsstox_rid_81777

    34. Dsstox_gsid_46628

    35. 128332-25-2

    36. Benzenesulfonamide, 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxy-, Monohydrochloride, (r)-

    37. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

    38. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzene Sulfonamide Monohydrochloride

    39. Cas-106463-17-6

    40. Tamsulosine Hydrochloride

    41. Ncgc00167442-01

    42. Mfcd00922997

    43. (r)-tamsulosin Hydrochloride

    44. Unii-11sv1951mr

    45. Tamsulosin.hcl

    46. Harnalidge Ocas

    47. Flomax Mr

    48. Alnaocas

    49. 5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl]-2-methoxybenzenesulfonamide Hydrochloride

    50. Flomax Hydrochloride

    51. Harnal (tn)

    52. Tamsulosin Hydrochloride [usan:usp:jan]

    53. Tamsulosina Hydrochloride

    54. Tamsulosinum Hydrochloride

    55. (-)-ly 253352

    56. Schembl23428

    57. Tamsulosin Hydrochloride,(s)

    58. Mls003899197

    59. Racemic Tamsulosin Hydrochloride

    60. Chembl1200914

    61. Dtxsid2046628

    62. Hy-b0661a

    63. 5-[(2rs)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride (tamsulosin Racemate Hydrochloride)

    64. Tox21_112446

    65. Eu-617

    66. S4729

    67. (r)-tamsulosin Hydrochloride- Bio-x

    68. Tamsulosin Hydrochloride (jp17/usp)

    69. Tamsulosin Hydrochloride [jan]

    70. Akos015895342

    71. Akos015995287

    72. Tox21_112446_1

    73. Bs-1019

    74. Ccg-269178

    75. Tamsulosin Hydrochloride [usan]

    76. (-)-ly253352

    77. Tamsulosin Hydrochloride [mart.]

    78. Tamsulosin Hydrochloride [vandf]

    79. Ncgc00167442-03

    80. Tamsulosin Hydrochloride [usp-rs]

    81. Tamsulosin Hydrochloride [who-dd]

    82. Bt164440

    83. Smr002543366

    84. Bcp0726000042

    85. Tamsulosin Hydrochloride, >=98% (hplc)

    86. T2749

    87. Y-617

    88. Tamsulosin Hydrochloride [orange Book]

    89. A14936

    90. D01024

    91. Jalyn Component Tamsulosin Hydrochloride

    92. Tamsulosin Hydrochloride [ep Monograph]

    93. Tamsulosin Hydrochloride [usp Impurity]

    94. Tamsulosin Hydrochloride [usp Monograph]

    95. 463t176

    96. A801444

    97. Tamsulosin Hydrochloride Component Of Jalyn

    98. Q-201777

    99. (r)-(-)-ym12617;ly253351

    100. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2

    101. Q27108379

    102. Tamsulosin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    103. Tamsulosin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    104. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hcl

    105. 5-((2r)-2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzene-sulfonamide Hcl

    106. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamidehydrochloride

    107. Tamsulosin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    108. Tamsulosin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    109. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride

    110. 5-[(2r)-2-[[2-(-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride;tamsulosin Hcl

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 445.0 g/mol
    Molecular Formula C20H29ClN2O5S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count11
    Exact Mass444.1485709 g/mol
    Monoisotopic Mass444.1485709 g/mol
    Topological Polar Surface Area108 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity539
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 4  
    Drug NameFlomax
    PubMed HealthTamsulosin (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
    Active IngredientTamsulosin hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength0.4mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    2 of 4  
    Drug NameTamsulosin hydrochloride
    Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
    Active IngredientTamsulosin hydrochloride
    Dosage FormCapsule
    Routeoral; Oral
    Strength0.4mg
    Market StatusTentative Approval; Prescription
    CompanySynthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs

    3 of 4  
    Drug NameFlomax
    PubMed HealthTamsulosin (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
    Active IngredientTamsulosin hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength0.4mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    4 of 4  
    Drug NameTamsulosin hydrochloride
    Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
    Active IngredientTamsulosin hydrochloride
    Dosage FormCapsule
    Routeoral; Oral
    Strength0.4mg
    Market StatusTentative Approval; Prescription
    CompanySynthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs

    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]

    API Reference Price

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LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"UNDISCLOSED","customerCountry":"JORDAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"9100","totalValueFC":"9089.2","currency":"USD","unitRateINR":780990.14000000001,"date":"26-Jun-2025","totalValueINR":"780990.14","totalValueInUsd":"9089.2","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"3031216","productDescription":"API","marketType":"","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"TAMSULOSIN HYDROCHLORIDE USP","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES LTD","supplierCountry":"INDIA","foreign_port":"TIANJIN","customer":"GREEN PINEPHARMA GROUP COLTD","customerCountry":"CHINA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"4100","totalValueFC":"20440.4","currency":"USD","unitRateINR":351269.40000000002,"date":"27-Jun-2025","totalValueINR":"1756347","totalValueInUsd":"20440.4","indian_port":"Hyderabad Air","hs_no":"29093019","bill_no":"3081433","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"TAMSULOSIN HYDROCHLORIDE","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE 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PETERSBURG","customer":"WERTEKS JOINT STOCK CO","customerCountry":"RUSSIA","quantity":"2600.00","actualQuantity":"2600","unit":"KGS","unitRateFc":"10148","totalValueFC":"294562.2","currency":"INR","unitRateINR":9734.7626923076932,"date":"28-Jun-2025","totalValueINR":"25310383","totalValueInUsd":"294562.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3101126","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pellets","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.22, FIRST FLOOR,PHASE - I, HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"TAMSULOSIN HYDROCHLORIDE (B) 103569 TU0A1303","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"CHEMO IBERICA S A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7500","totalValueFC":"7564.4","currency":"USD","unitRateINR":"601875","date":"05-Aug-2022","totalValueINR":"601875","totalValueInUsd":"7564.4","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"9880115","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712082600,"product":"TAMSULOSIN HYDROCHLORIDE-103569 - TAMSULOSIN HYDROCHLORIDE (B)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CHEMO IBERICA S A","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"2.93","actualQuantity":"2.93","unit":"KGS","unitRateFc":"6500","totalValueFC":"19157.4","currency":"USD","unitRateINR":"546000","date":"03-Apr-2024","totalValueINR":"1599780","totalValueInUsd":"19157.4","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"2864063","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"Manuel Pombo Angulo, 28, 3rd floor28050 Madrid - SpainSDNF Spain","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739557800,"product":"TAMSULOSIN HYDROCHLORIDE USP (REJECTED GOODS VIDE SB NO:1792642 \/19.06.2024,INVOICE NO:380\/24-25\/233 DT:13.06.2024)TAMSULOSIN HYDROCHLORIDE USP (REJECTED GOODS VIDE SB NO:1792","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"KYUNG DONG PHARM COLTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"APITORIA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"10687.9","totalValueFC":"43457.4","currency":"USD","unitRateINR":"944808.2","date":"15-Feb-2025","totalValueINR":"3779232.6","totalValueInUsd":"43457.4","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"8380973","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"224-3,JEYAKDANJI-RO, YANGGAM-MYEON, HWASEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA. Korea, Republic of","customerAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower"}]
    03-Jan-2022
    28-Jun-2025
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    DOSAGE - CAPSULE;ORAL - 0.4MG

    USFDA APPLICATION NUMBER - 20579

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    DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

    USFDA APPLICATION NUMBER - 22460

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    ABOUT THIS PAGE

    Looking for 106463-17-6 / Tamsulosin API manufacturers, exporters & distributors?

    Tamsulosin manufacturers, exporters & distributors 1

    18

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

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

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

    API | Excipient name

    Tamsulosin

    Synonyms

    106463-17-6, Flomax, Tamsulosin hcl, Omnic, Pradif, Harnal

    Cas Number

    106463-17-6

    Unique Ingredient Identifier (UNII)

    11SV1951MR

    About Tamsulosin

    A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.

    Pradif Manufacturers

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

    Pradif Suppliers

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

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

    Pradif USDMF

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

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

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

    Pradif JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Pradif Drug Master File in Japan (Pradif JDMF) empowers Pradif API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Pradif JDMF during the approval evaluation for pharmaceutical products. At the time of Pradif JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Pradif suppliers with JDMF on PharmaCompass.

    Pradif KDMF

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

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

    After submitting a Pradif 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 Pradif API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Pradif suppliers with KDMF on PharmaCompass.

    Pradif CEP

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

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

    Pradif WC

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

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

    Pradif 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 Pradif as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Pradif GMP

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

    Pradif CoA

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

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

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