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    Chemistry

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    Also known as: 147536-97-8, Tracleer, Actelion, Bosentan anhydrous, Ro 47-0203, Ro-47-0203
    Molecular Formula
    C27H29N5O6S
    Molecular Weight
    551.6  g/mol
    InChI Key
    GJPICJJJRGTNOD-UHFFFAOYSA-N
    FDA UNII
    XUL93R30K2
    Bosentan Hydrate
    A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS.
    Bosentan anhydrous is an Endothelin Receptor Antagonist. The mechanism of action of bosentan anhydrous is as an Endothelin Receptor Antagonist, and Cytochrome P450 3A Inducer, and Cytochrome P450 2C9 Inducer.
    1 2D Structure

    Bosentan Hydrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-ylpyrimidin-4-yl]benzenesulfonamide
    2.1.2 InChI
    InChI=1S/C27H29N5O6S/c1-27(2,3)18-10-12-19(13-11-18)39(34,35)32-23-22(38-21-9-6-5-8-20(21)36-4)26(37-17-16-33)31-25(30-23)24-28-14-7-15-29-24/h5-15,33H,16-17H2,1-4H3,(H,30,31,32)
    2.1.3 InChI Key
    GJPICJJJRGTNOD-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(C)C1=CC=C(C=C1)S(=O)(=O)NC2=C(C(=NC(=N2)C3=NC=CC=N3)OCCO)OC4=CC=CC=C4OC
    2.2 Other Identifiers
    2.2.1 UNII
    XUL93R30K2
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-t-butyl-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide

    2. Bosentan Anhydrous

    3. Bosentan Monohydrate

    4. Ro 47 0203

    5. Ro 47-0203

    6. Ro 470203

    7. Ro-47-0203

    8. Tracleer

    2.3.2 Depositor-Supplied Synonyms

    1. 147536-97-8

    2. Tracleer

    3. Actelion

    4. Bosentan Anhydrous

    5. Ro 47-0203

    6. Ro-47-0203

    7. Anhydrous Bosentan

    8. Bosentan [usan:inn:ban]

    9. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-ylpyrimidin-4-yl]benzenesulfonamide

    10. P-tert-butyl-n-(6-(2-hydroxyethoxy)-5-(o-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl)benzenesulfonamide

    11. Bosentan (inn)

    12. 4-(tert-butyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide

    13. Chembl957

    14. Xul93r30k2

    15. N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]-4-tert-butyl-benzenesulfonamide

    16. Chebi:51450

    17. 147536-97-8 (free)

    18. 174227-18-0

    19. Benzenesulfonamide, 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)(2,2'-bipyrimidin)-4-yl)-

    20. Ncgc00167440-01

    21. Bosentan [inn]

    22. Dsstox_cid_26627

    23. Dsstox_rid_81776

    24. Dsstox_gsid_46627

    25. 1174918-31-0

    26. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) Benzenesulfornamide

    27. 4-tert-butyl-n-[6-(2-hydroxyethyloxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide

    28. Benzenesulfonamide, 4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]-

    29. Bosentanum

    30. Ro-47-0203/029

    31. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl]benzenesulfonamide

    32. Cas-147536-97-8

    33. Ro 47-0203/039

    34. Sr-05000001532

    35. Ro-470203029

    36. Ro-47-0203-029

    37. Unii-xul93r30k2

    38. 4-tert-butyl-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide

    39. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl)benzenesulfornamide

    40. Ks-5062

    41. Starbld0043886

    42. Bosentan [mi]

    43. Ro-47-0203/039

    44. Bosentan [who-dd]

    45. Schembl4218

    46. Gtpl3494

    47. Dtxsid7046627

    48. Hms2090n14

    49. Hms3652f15

    50. Hms3715n05

    51. Hms3750a13

    52. Bcp05202

    53. Hy-a0013

    54. Zinc1538857

    55. Tox21_112444

    56. Ac-148

    57. Bdbm50061101

    58. Pdsp1_001731

    59. Pdsp2_001714

    60. S4220

    61. Akos015852063

    62. Tox21_112444_1

    63. Am84442

    64. Bcp9000445

    65. Ccg-221182

    66. Cs-0381

    67. Db00559

    68. Sb17356

    69. Ncgc00167440-02

    70. Bb164259

    71. B5118

    72. Ft-0658809

    73. Sw199648-3

    74. D07538

    75. W18800

    76. Ab01275536-01

    77. 212b550

    78. A808658

    79. L001086

    80. Q419769

    81. J-008366

    82. Sr-05000001532-1

    83. Sr-05000001532-2

    84. Sr-05000001532-4

    85. Z1541632805

    86. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2''-bipyrimidin)-4-yl) Benzenesulfornamide

    87. 4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide

    88. 4-(tert-butyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide

    89. 4-tert Butyl-n-[4-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)pyrimidin-6-yl]benzenesulphonamide

    90. 4-tert-butyl-n-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide

    91. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidine]-4-yl]benzene-1-sulfonamide

    92. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2''-bipyrimidin-4-yl]benzenesulfonamide

    93. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide

    94. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzene-1-sulfonamide

    95. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide

    96. K86

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 551.6 g/mol
    Molecular Formula C27H29N5O6S
    XLogP33.8
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count11
    Exact Mass551.18385484 g/mol
    Monoisotopic Mass551.18385484 g/mol
    Topological Polar Surface Area154 Ų
    Heavy Atom Count39
    Formal Charge0
    Complexity839
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTracleer
    PubMed HealthBosentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelTracleer is the proprietary name for bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-me...
    Active IngredientBosentan
    Dosage FormTablet
    RouteOral
    Strength125mg; 62.5mg
    Market StatusPrescription
    CompanyActelion Pharms

    2 of 2  
    Drug NameTracleer
    PubMed HealthBosentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelTracleer is the proprietary name for bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-me...
    Active IngredientBosentan
    Dosage FormTablet
    RouteOral
    Strength125mg; 62.5mg
    Market StatusPrescription
    CompanyActelion Pharms

    4.2 Drug Indication

    Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).

    FDA Label

    Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:

    - Primary (idiopathic and familial) PAH;

    - PAH secondary to scleroderma without significant interstitial pulmonary disease;

    - PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology.

    Some improvements have also been shown in patients with PAH WHO functional class II.

    Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Bosentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Bosentan blocks the binding of endothelin to its receptors, thereby negating endothelin's deleterious effects.

    5.2 MeSH Pharmacological Classification

    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.)

    Endothelin Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN RECECPTORS. (See all compounds classified as Endothelin Receptor Antagonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    BOSENTAN ANHYDROUS
    5.3.2 FDA UNII
    XUL93R30K2
    5.3.3 Pharmacological Classes
    Cytochrome P450 3A Inducers [MoA]; Endothelin Receptor Antagonist [EPC]; Endothelin Receptor Antagonists [MoA]; Cytochrome P450 2C9 Inducers [MoA]
    5.4 ATC Code

    C02KX01

    C02KX01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    C - Cardiovascular system

    C02 - Antihypertensives

    C02K - Other antihypertensives

    C02KX - Antihypertensives for pulmonary arterial hypertension

    C02KX01 - Bosentan

    5.5 Absorption, Distribution and Excretion

    Absorption

    Absolute bioavailability is approximately 50% and food does not affect absorption.

    Route of Elimination

    Bosentan is eliminated by biliary excretion following metabolism in the liver.

    Volume of Distribution

    18 L

    Clearance

    4 L/h [patients with pulmonary arterial hypertension]

    5.6 Metabolism/Metabolites

    Bosentan is metabolized in the liver by the cytochrome P450 enzymes CYP2C9 and CYP3A4 (and possibly CYP2C19), producing three metabolites, one of which, Ro 48-5033, is pharmacologically active and may contribute 10 to 20% to the total activity of the parent compound.

    Bosentan has known human metabolites that include 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-hydroxyphenoxy)-[2,2-]bipyrimidinyl-4-yl]-benzenesulfonamide and Hydroxy Bosentan.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Terminal elimination half-life is about 5 hours in healthy adult subjects.

    5.8 Mechanism of Action

    Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by binding to ETA and ETB receptors in the endothelium and vascular smooth muscle. It displays a slightly higher affinity towards ETA receptors than ETB receptors. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in this disease. Bosentan is a specific and competitive antagonist at endothelin receptor types ETA and ETB.

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    HONOUR LAB LTD

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Duphat
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36018

    Submission : 2021-09-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-26

    Valid Till : 2022-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

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    ✖

    NDC Package Code : 69037-0005

    Start Marketing Date : 2001-11-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    Digital Content

    Website

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    10

    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Duphat
    Not Confirmed
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    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Duphat
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-05-22

    Pay. Date : 2018-04-27

    DMF Number : 32757

    Submission : 2018-04-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    API Reference Price

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INGREDIENTS)RAW MATERIAL FOR USE IN PHARMACEUTICAL INDUSTRIESFOR HUMAN USE BOSENTAN MONOHYDRATE","address":"C-1009, SIDDHI VINAYAK TOWER, OFF. S.G HIGHWAY, MAKARBA","city":"AHMEDABAD","supplier":"CHEMFORTE INDIA PRIVATE ","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"O? HERVANARIO, S DE. R.L.","customerCountry":"MEXICO","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"6756","totalValueFC":"6684.8","currency":"USD","unitRateINR":558045.82999999996,"date":"25-Jun-2024","totalValueINR":"558045.83","totalValueInUsd":"6684.8","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"1928994","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"C-1009, SIDDHI VINAYAK TOWER, OFF. S.G HIGHWAY, MAKARBA, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"BOSENTAN MONOHYDRATE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"HERTIZ PHARMA PTE. LTD.","customerCountry":"ARGENTINA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"2137","totalValueFC":"25401.6","currency":"USD","unitRateINR":176945.5,"date":"22-Jul-2024","totalValueINR":"2123346","totalValueInUsd":"25401.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29359090","bill_no":"4000611","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721759400,"product":"API(ACTIVE PHARMAC. INGREDIENTS)RAW MATERIAL FOR USE IN PHARM.IND.FOR HUMAN USEBOSENTAN MONOHYDRATE","address":"C-1009, SIDDHI VINAYAK TOWER, OFF. S.G HIGHWAY, MAKARBA","city":"AHMEDABAD","supplier":"CHEMFORTE INDIA PRIVATE ","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"MEXICO","customerCountry":"MEXICO","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"6756","totalValueFC":"6574.5","currency":"USD","unitRateINR":549570.96999999997,"date":"24-Jul-2024","totalValueINR":"549570.97","totalValueInUsd":"6574.5","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"2654709","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"C-1009, SIDDHI VINAYAK TOWER, OFF. S.G HIGHWAY, MAKARBA, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724869800,"product":"ACTIVE PHARMACEUTICAL INGREDIENTS-OTHERORGANIC CHEMICAL COMPOUNDS:- BOSENTAN MONOHYDRATE","address":"SETHNA BUILDING, 4TH FLR,","city":"LINES, MUMBAI ,MAHARASHTRA","supplier":"MEGAFINE PHARMA (P) LIMITED","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"TO THE ORDER OF.,","customerCountry":"SPAIN","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1980","totalValueFC":"29275.7","currency":"USD","unitRateINR":163707,"date":"29-Aug-2024","totalValueINR":"2455605","totalValueInUsd":"29275.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3594940","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SETHNA BUILDING, 4TH FLR,, LINES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"BOSENTAN H20","address":"N\/A","city":"N\/A","supplier":"TIANISH LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"VIDARA LIFE INGREDIENTS SAU","customerCountry":"SPAIN","quantity":"25.98","actualQuantity":"25.98","unit":"KGS","unitRateFc":"3000","totalValueFC":"77227.2","currency":"USD","unitRateINR":249104.51655119323,"date":"05-Sep-2024","totalValueINR":"6471735.34","totalValueInUsd":"77227.2","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"3792809","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726079400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS(API)(PHARMACEUTICALS RAW MATERIAL FOR PHARMAINDUSTRIES)PRODUCT - BOSENTAN","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"9.50","actualQuantity":"9.5","unit":"KGS","unitRateFc":"1300","totalValueFC":"12059","currency":"USD","unitRateINR":106374.40736842105,"date":"12-Sep-2024","totalValueINR":"1010556.87","totalValueInUsd":"12059","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"3964778","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726770600,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS ? 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ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"BOSENTAN MONOHYDRATE IN HOUSE ( PHARMACEUTICAL RAW MATERIAL) ( QTY 3 KGS) BATCHNO:BOS 241008P11E","address":"PLOT NO.4717","city":"N\/A","supplier":"PURE CHEM PVT LTD","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"MEEZAN BANK LIMITED","customerCountry":"PAKISTAN","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1370","totalValueFC":"3937.9","currency":"USD","unitRateINR":110295.46666666667,"date":"18-Oct-2024","totalValueINR":"330886.4","totalValueInUsd":"3937.9","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"4915540","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"PLOT NO.4717, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"BOSENTAN MONOHYDRATE","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS & PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"PARIS - CHARLES DE G","customer":"TO THE ORDER OF","customerCountry":"FRANCE","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1000","totalValueFC":"9901.6","currency":"USD","unitRateINR":83200,"date":"22-Oct-2024","totalValueINR":"832000","totalValueInUsd":"9901.6","indian_port":"Madras Air","hs_no":"29359090","bill_no":"5024726","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"BOSENTAN MONOHYDRATE","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS & PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"PARIS - CHARLES DE G","customer":"TO THE ORDER OF","customerCountry":"FRANCE","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1000","totalValueFC":"9901.6","currency":"USD","unitRateINR":83200,"date":"22-Oct-2024","totalValueINR":"832000","totalValueInUsd":"9901.6","indian_port":"Madras Air","hs_no":"29359090","bill_no":"5025680","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"BOSENTAN MONOHYDRATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"GENVION CORPORATION","customerCountry":"CANADA","quantity":"52.00","actualQuantity":"52","unit":"KGS","unitRateFc":"2800","totalValueFC":"142994.5","currency":"USD","unitRateINR":232058.65384615384,"date":"07-Nov-2024","totalValueINR":"12067050","totalValueInUsd":"142994.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5416568","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645122600,"product":"BOSENTAN RELATED COMPOUND B (QTY: 1 X 15 MG, PRICE: USD 860)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.000015","unit":"KGS","unitRateFc":"57333333.3","totalValueFC":"910.7","currency":"USD","unitRateINR":"4550788667","date":"18-Feb-2022","totalValueINR":"68261.83","totalValueInUsd":"910.7","indian_port":"HYDERABAD AIR","hs_no":"29359090","bill_no":"7555084","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703529000,"product":"(N.C.V) IMPURITY OF BOSENTAN (JNJ-75096411-AAA) BENZENESULFONAMIDE,4-(1,1-DIMETHYLETHYL)-N-[6-ETHOXY]-5-(2-METHOXYPHENOX","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.2","unit":"GMS","unitRateFc":"1327","totalValueFC":"294.4","currency":"EUR","unitRateINR":"122548.5","date":"26-Dec-2023","totalValueINR":"24509.69","totalValueInUsd":"294.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"9407835","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703529000,"product":"(N.C.V) IMPURITY OF BOSENTAN (JNJ-75096437-AAA)4-TERT BUTYL-N-[6-(2-ISOBUTOXYYETHOXY)-5-(2-METHOXYPHENOXY)-2-PYRIMIDIN-2","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.2","unit":"GMS","unitRateFc":"1327","totalValueFC":"294.4","currency":"EUR","unitRateINR":"122548.5","date":"26-Dec-2023","totalValueINR":"24509.69","totalValueInUsd":"294.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"9407835","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710441000,"product":"RE-IMPORT OF BOSENTAN 2304006390\/62923083 (INV. NO. 6770035828 - QTY. 15 AS PER INV.)","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"PLIVA HRVATSKA","supplierCountry":"INDIA","foreign_port":"ZAGREB","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"14.93","actualQuantity":"14.934","unit":"KGS","unitRateFc":"2800","totalValueFC":"43233.2","currency":"USD","unitRateINR":"240384.7","date":"15-Mar-2024","totalValueINR":"3589905.26","totalValueInUsd":"43233.2","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"2591960","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRILAZ BARUNA FILIPOVICA 25ZAGREB 10000SDNF CROATIA","customerAddress":"ALEMBIC ROAD"}]
    02-Feb-2021
    07-Nov-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    INTERMEDIATES SUPPLIERS

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    01

    Acharya Chemicals

    India
    BIO Partnering at JPM
    Not Confirmed
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    Acharya Chemicals

    India
    BIO Partnering at JPM
    Not Confirmed
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    4- (1,1-dimethylethyl)-N-[6-chloro-5- (2-methoxyph...

    CAS Number : 150727-06-3

    End Use API : Bosentan Hydrate

    About The Company : Established in 1975, Acharya Group is a trusted and well-established chemical manufacturing company renowned for its commitment to technological excellence. Ach...

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    02

    Bakul Group

    India
    BIO Partnering at JPM
    Not Confirmed
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    Bakul Group

    India
    BIO Partnering at JPM
    Not Confirmed
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    tert-Butyl benzene sulfonamide

    CAS Number : 6292-59-7

    End Use API : Bosentan Hydrate

    About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...

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    03

    Ramdev Chemical Pvt Ltd

    India
    BIO Partnering at JPM
    Not Confirmed
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    Ramdev Chemical Pvt Ltd

    India
    BIO Partnering at JPM
    Not Confirmed
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    Diethyl (O-Methoxy Phenoxy) Malonate

    CAS Number : 150726-89-9

    End Use API : Bosentan Hydrate

    About The Company : Ramdev Chemicals Pvt. Ltd. is one of the fastest growing Active Pharmaceuticl Drugs, Drug Intermediates, Storage Fine Chemical Company in India which have speci...

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    04

    Ramdev Chemical Pvt Ltd

    India
    BIO Partnering at JPM
    Not Confirmed
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    Ramdev Chemical Pvt Ltd

    India
    BIO Partnering at JPM
    Not Confirmed
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    2-Amidino pyrimidine acetate

    CAS Number : 138588-40-6

    End Use API : Bosentan Hydrate

    About The Company : Ramdev Chemicals Pvt. Ltd. is one of the fastest growing Active Pharmaceuticl Drugs, Drug Intermediates, Storage Fine Chemical Company in India which have speci...

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    05

    Sagar Life Sciences

    India
    BIO Partnering at JPM
    Not Confirmed
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    Sagar Life Sciences

    India
    BIO Partnering at JPM
    Not Confirmed
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    4 Tertbutyl Benzenesulfonamide

    CAS Number : 6292-59-7

    End Use API : Bosentan Hydrate

    About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

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    06

    Sandoo Pharmaceuticals and Chemcial...

    China
    BIO Partnering at JPM
    Not Confirmed
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    Sandoo Pharmaceuticals and Chemcial...

    China
    BIO Partnering at JPM
    Not Confirmed
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    2-Amidinopyrimidine hydrochloride

    CAS Number : 138588-40-6

    End Use API : Bosentan Hydrate

    About The Company : Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and imp...

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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Europe

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    01

    ABDI FARMA GMBH

    Italy
    Biotech Showcase
    Not Confirmed
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    ABDI FARMA GMBH

    Italy
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 125MG

    USFDA APPLICATION NUMBER - 21290

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    DOSAGE - TABLET;ORAL - 62.5MG

    USFDA APPLICATION NUMBER - 21290

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    ABOUT THIS PAGE

    Bosentan Hydrate Manufacturers

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

    Bosentan Hydrate Suppliers

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

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

    Bosentan Hydrate USDMF

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

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

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

    Bosentan Hydrate 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 Bosentan Hydrate Drug Master File in Japan (Bosentan Hydrate JDMF) empowers Bosentan Hydrate 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 Bosentan Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Bosentan Hydrate 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 Bosentan Hydrate suppliers with JDMF on PharmaCompass.

    Bosentan Hydrate KDMF

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

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

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

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

    Bosentan Hydrate WC

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

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

    Bosentan Hydrate 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 Bosentan Hydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Bosentan Hydrate GMP

    Bosentan Hydrate 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 Bosentan Hydrate 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 Bosentan Hydrate GMP manufacturer or Bosentan Hydrate GMP API supplier for your needs.

    Bosentan Hydrate CoA

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

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

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