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    Chemistry

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    Also known as: Torasemide, 56211-40-6, Demadex, Luprac, Torasemida, Torasemidum
    Molecular Formula
    C16H20N4O3S
    Molecular Weight
    348.4  g/mol
    InChI Key
    NGBFQHCMQULJNZ-UHFFFAOYSA-N
    FDA UNII
    W31X2H97FB
    Torsemide
    A pyridine and sulfonamide derivative that acts as a sodium-potassium chloride symporter inhibitor (loop diuretic). It is used for the treatment of EDEMA associated with CONGESTIVE HEART FAILURE; CHRONIC RENAL INSUFFICIENCY; and LIVER DISEASES. It is also used for the management of HYPERTENSION.
    Torsemide is a Loop Diuretic. The physiologic effect of torsemide is by means of Increased Diuresis at Loop of Henle.
    1 2D Structure

    Torsemide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[4-(3-methylanilino)pyridin-3-yl]sulfonyl-3-propan-2-ylurea
    2.1.2 InChI
    InChI=1S/C16H20N4O3S/c1-11(2)18-16(21)20-24(22,23)15-10-17-8-7-14(15)19-13-6-4-5-12(3)9-13/h4-11H,1-3H3,(H,17,19)(H2,18,20,21)
    2.1.3 InChI Key
    NGBFQHCMQULJNZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=CC=C1)NC2=C(C=NC=C2)S(=O)(=O)NC(=O)NC(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    W31X2H97FB
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-isopropyl-3-((4-(3-methylphenylamino)pyridine)-3-sulfonyl)urea

    2. 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulfonyl)urea

    3. Demadex

    4. Torasemide

    2.3.2 Depositor-Supplied Synonyms

    1. Torasemide

    2. 56211-40-6

    3. Demadex

    4. Luprac

    5. Torasemida

    6. Torasemidum

    7. Torasemidum [inn-latin]

    8. Torasemida [inn-spanish]

    9. Unat

    10. Ac-4464

    11. Torasemide Anhydrous

    12. Jdl 464

    13. Torem

    14. Bm-02015

    15. Ac4464

    16. N-(isopropylcarbamoyl)-4-(m-tolylamino)pyridine-3-sulfonamide

    17. Soaanz

    18. Upcard

    19. 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulfonyl)urea

    20. Ac 4464

    21. Jdl-464

    22. Bm 02015

    23. 1-[4-(3-methylanilino)pyridin-3-yl]sulfonyl-3-propan-2-ylurea

    24. Torasemide [inn]

    25. Torsemide (demadex)

    26. Torasemide, Anhydrous

    27. Bm02.015

    28. N-(((1-methylethyl)amino)carbonyl)-4-((3-methylphenyl)amino)-3-pyridinesulfonamide

    29. Bm-02.015

    30. Mls001165687

    31. Chebi:9637

    32. W31x2h97fb

    33. 3-pyridinesulfonamide, N-(((1-methylethyl)amino)carbonyl)-4-((3-methylphenyl)amino)-

    34. Torsemide [usan]

    35. Ncgc00016879-01

    36. Smr000466313

    37. Toradiur

    38. Cas-56211-40-6

    39. 1-{4-[(3-methylphenyl)amino]pyridine-3-sulfonyl}-3-(propan-2-yl)urea

    40. Dsstox_cid_3690

    41. N-[(isopropylamino)carbonyl]-4-[(3-methylphenyl)amino]pyridine-3-sulfonamide

    42. 3-pyridinesulfonamide, N-[[(1-methylethyl)amino]carbonyl]-4-[(3-methylphenyl)amino]-

    43. Dsstox_rid_77149

    44. Dsstox_gsid_23690

    45. Dilutol

    46. Torocard

    47. Sutril

    48. Torrem

    49. Torasemide N

    50. 4-[(3-methylphenyl)amino]-n-(propan-2-ylcarbamoyl)pyridine-3-sulfonamide

    51. N-{[(1-methylethyl)amino]carbonyl}-4-[(3-methylphenyl)amino]pyridine-3-sulfonamide

    52. Torsemide (usp)

    53. Demadex (tn)

    54. Luprac (tn)

    55. Ccris 6736

    56. Torasemide (jan/inn)

    57. Torsemide [usan:usp]

    58. Gj-1090

    59. Brn 0498515

    60. Unii-w31x2h97fb

    61. Mfcd00866166

    62. Ks-1123

    63. Pw-2132

    64. Spectrum_001776

    65. Torsemide [mi]

    66. Torasemide [jan]

    67. Prestwick0_001030

    68. Prestwick1_001030

    69. Prestwick2_001030

    70. Prestwick3_001030

    71. Spectrum2_001142

    72. Spectrum3_001832

    73. Spectrum4_000290

    74. Spectrum5_001699

    75. Torsemide [vandf]

    76. Torasemide [mart.]

    77. Torsemide [usp-rs]

    78. Chembl1148

    79. Torasemide [who-dd]

    80. Schembl41184

    81. Bspbio_001219

    82. Bspbio_003503

    83. Kbiogr_000820

    84. Kbioss_002257

    85. Cid_41781

    86. Mls000759418

    87. Mls001195611

    88. Mls001424121

    89. Mls006010744

    90. Bidd:gt0623

    91. Spectrum1505211

    92. Spbio_001063

    93. Spbio_003080

    94. Bpbio1_001341

    95. Gtpl7312

    96. Zinc5823

    97. Torsemide [orange Book]

    98. Dtxsid2023690

    99. Torsemide [usp Impurity]

    100. Bdbm64107

    101. Kbio2_002256

    102. Kbio2_004824

    103. Kbio2_007392

    104. Kbio3_003008

    105. Torasemide For System Suitability

    106. Torasemide [ep Monograph]

    107. Torsemide [usp Monograph]

    108. Hms1571m21

    109. Hms1922n05

    110. Hms2051l21

    111. Hms2098m21

    112. Hms2234n14

    113. Hms3373g20

    114. Hms3393l21

    115. Hms3715m21

    116. Hms3744g19

    117. Albb-027267

    118. Bcp07286

    119. Hy-b0247

    120. Tox21_110662

    121. Ccg-40257

    122. S1698

    123. Stl388026

    124. Torsemide, >=98% (hplc), Solid

    125. Akos015894937

    126. Tox21_110662_1

    127. Bm02015

    128. Db00214

    129. Nc00238

    130. Ncgc00016879-02

    131. Ncgc00016879-03

    132. Ncgc00016879-04

    133. Ncgc00016879-06

    134. Ncgc00016879-07

    135. Ncgc00095141-01

    136. Ncgc00095141-02

    137. Ncgc00095141-03

    138. Ac-18762

    139. Ab00514011

    140. Ft-0630689

    141. Ft-0675300

    142. T2538

    143. D00382

    144. T72621

    145. Ab00514011-09

    146. Ab00514011_10

    147. Ab00514011_11

    148. 211t406

    149. A830961

    150. Q419948

    151. Sr-01000759362

    152. Torasemide Anhydrous [ema Epar Veterinary]

    153. Q-201846

    154. Sr-01000759362-5

    155. Brd-k30480208-001-05-2

    156. Torsemide, United States Pharmacopeia (usp) Reference Standard

    157. 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulphonyl)urea

    158. 4-(3-methylanilino)-n-(propan-2-ylcarbamoyl)pyridine-3-sulfonamide

    159. Torasemide Anhydrous, European Pharmacopoeia (ep) Reference Standard

    160. 1-isopropyl-3-[[4-(3-methylanilino)-3-pyridyl]sulfonyl]urea;torsemide

    161. N-(isopropylcarbamoyl)-4-[(3-methylphenyl)amino]pyridine-3-sulfonamide

    162. N-[(propan-2-yl)carbamoyl]-4-[(3-methylphenyl)amino]pyridine-3-sulfonamide

    163. N-({4-[(3-methylphenyl)imino]-1,4-dihydropyridin-3-yl}sulfonyl)propane-2-carbamimidic Acid

    164. Torasemide For System Suitability, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 348.4 g/mol
    Molecular Formula C16H20N4O3S
    XLogP32.7
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count5
    Exact Mass348.12561169 g/mol
    Monoisotopic Mass348.12561169 g/mol
    Topological Polar Surface Area109 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity518
    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 4  
    Drug NameDemadex
    PubMed HealthTorsemide
    Drug ClassesCardiovascular Agent
    Drug LabelDEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is:Its empirical formula is C16H20N4O3S, its pKa is 7.1, and its molecular...
    Active IngredientTorsemide
    Dosage FormTablet
    RouteOral
    Strength5mg; 100mg; 10mg; 20mg
    Market StatusPrescription
    CompanyMeda Pharms

    2 of 4  
    Drug NameTorsemide
    PubMed HealthTorsemide
    Drug ClassesCardiovascular Agent
    Drug LabelDEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is:Its empirical formula is C16H20N4O3S, its pKa is 7.1, and its molecular...
    Active IngredientTorsemide
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength50mg/5ml (10mg/ml); 5mg; 20mg/2ml (10mg/ml); 100mg; 10mg; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Teva; Apotex; Hetero Labs Ltd Iii; Pliva Pharm Ind; Sun Pharm Inds; Aurobindo Pharma; Par Pharm; Roxane; Luitpold; Eurohlth Intl

    3 of 4  
    Drug NameDemadex
    PubMed HealthTorsemide
    Drug ClassesCardiovascular Agent
    Drug LabelDEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is:Its empirical formula is C16H20N4O3S, its pKa is 7.1, and its molecular...
    Active IngredientTorsemide
    Dosage FormTablet
    RouteOral
    Strength5mg; 100mg; 10mg; 20mg
    Market StatusPrescription
    CompanyMeda Pharms

    4 of 4  
    Drug NameTorsemide
    PubMed HealthTorsemide
    Drug ClassesCardiovascular Agent
    Drug LabelDEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is:Its empirical formula is C16H20N4O3S, its pKa is 7.1, and its molecular...
    Active IngredientTorsemide
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength50mg/5ml (10mg/ml); 5mg; 20mg/2ml (10mg/ml); 100mg; 10mg; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Teva; Apotex; Hetero Labs Ltd Iii; Pliva Pharm Ind; Sun Pharm Inds; Aurobindo Pharma; Par Pharm; Roxane; Luitpold; Eurohlth Intl

    4.2 Drug Indication

    Torasemide is indicated for the treatment of edema associated with congestive heart failure, renal or hepatic diseases. From this condition, it has been observed that torasemide is very effective in cases of kidney failure. As well, torasemide is approved to be used as an antihypertensive agent either alone or in combination with other antihypertensives.

    FDA Label

    For treatment of clinical signs, including oedema and effusion, related to congestive heart failure in dogs.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    It is widely known that administration of torasemide can attenuate renal injury and reduce the severity of acute renal failure. This effect is obtained by increasing urine output and hence, facilitating fluid, acid-base and potassium control. This effect is obtained by the increase in the excretion of urinary sodium and chloride. Several reports have indicated that torasemide presents a long-lasting diuresis and less potassium excretion which can be explained by the effect that torasemide has on the renin-angiotensin-aldosterone system. This effect is very similar to the effect observed with the administration of combination therapy with [furosemide] and [spironolactone] and it is characterized by a decrease in plasma brain natriuretic peptide and improved measurements of left ventricular function. Above the aforementioned effect, torasemide presents a dual effect .in which the inhibition of aldosterone which donates torasemide with a potassium-sparing action. Torasemide has been shown to reduce extracellular fluid volume and blood pressure in hypertensive patients suffering from chronic kidney disease. As well, some reports have indicated that torasemide can reduce myocardial fibrosis by reducing the collagen accumulation. This effect is suggested to be related to the decrease in aldosterone which in order has been shown to reduce the production of the enzyme procollagen type I carboxy-terminal proteinase which is known to be overexpressed in heart failure patients.

    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.)

    Sodium Potassium Chloride Symporter Inhibitors

    Agents that inhibit SODIUM-POTASSIUM-CHLORIDE SYMPORTERS which are concentrated in the thick ascending limb at the junction of the LOOP OF HENLE and KIDNEY TUBULES, DISTAL. They act as DIURETICS. Excess use is associated with HYPOKALEMIA and HYPERGLYCEMIA. (See all compounds classified as Sodium Potassium Chloride Symporter Inhibitors.)

    Diuretics

    Agents that promote the excretion of urine through their effects on kidney function. (See all compounds classified as Diuretics.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TORSEMIDE
    5.3.2 FDA UNII
    W31X2H97FB
    5.3.3 Pharmacological Classes
    Loop Diuretic [EPC]; Increased Diuresis at Loop of Henle [PE]
    5.4 ATC Code

    QC03CA04

    C03CA04

    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

    C03 - Diuretics

    C03C - High-ceiling diuretics

    C03CA - Sulfonamides, plain

    C03CA04 - Torasemide

    5.5 Absorption, Distribution and Excretion

    Absorption

    Torasemide is the diuretic with the highest oral bioavailability even in advanced stages of chronic kidney disease. This bioavailability tends to be higher than 80% regardless of the patient condition. The maximal serum concentration is reported to be of 1 hour and the absorption parameters are not affected by its use concomitantly with food.

    Route of Elimination

    Torasemide is mainly hepatically processed and excreted in the feces from which about 70-80% of the administered dose is excreted by this pathway. On the other hand, about 20-30% of the administered dose is found in the urine.

    Volume of Distribution

    The volume of distribution of torasemide is 0.2 L/kg.

    Clearance

    The clearance rate of torasemide is considerably reduced by the presence of renal disorders.

    5.6 Metabolism/Metabolites

    Torasemide is extensively metabolized in the liver and only 20% of the dose remains unchanged and it is recovered in the urine. Metabolized via the hepatic CYP2C8 and CYP2C9 mainly by reactions of hydroxylation, oxidation and reduction to 5 metabolites. The major metabolite, M5, is pharmacologically inactive. There are 2 minor metabolites, M1, possessing one-tenth the activity of torasemide, and M3, equal in activity to torasemide. Overall, torasemide appears to account for 80% of the total diuretic activity, while metabolites M1 and M3 account for 9% and 11%, respectively.

    Torasemide has known human metabolites that include N-[(4-{[3-(hydroxymethyl)phenyl]imino}-1,4-dihydropyridin-3-yl)sulfonyl]propane-2-carbamimidic acid.

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

    5.7 Biological Half-Life

    The average half-life of torasemide is 3.5 hours.

    5.8 Mechanism of Action

    As mentioned above, torasemide is part of the loop diuretics and thus, it acts by reducing the oxygen demand in the medullary thick ascending loop of Henle by inhibiting the Na+/K+/Cl- pump on the luminal cell membrane surface. This action is obtained by the binding of torasemide to a chloride ion-binding site of the transport molecule. Torasemide is known to have an effect in the renin-angiotensin-aldosterone system by inhibiting the downstream cascade after the activation of angiotensin II. This inhibition will produce a secondary effect marked by the reduction of the expression of aldosterone synthase, TGF-B1 and thromboxane A2 and a reduction on the aldosterone receptor binding.

    API Reference Price

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PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"409.60","actualQuantity":"409.6","unit":"KGS","unitRateFc":"160","totalValueFC":"64171.9","currency":"USD","unitRateINR":13164.411279296875,"date":"08-Oct-2024","totalValueINR":"5392142.86","totalValueInUsd":"64171.9","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"4669052","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"TORSEMIDE USP","address":"44-FAIZ-E-EDROOS,371-373","city":"MUMBAI ,MAHARASHTRA","supplier":"JAYANA PHARMA","supplierCountry":"INDIA","foreign_port":"BHAIRAWA","customer":"BIOGAIN REMEDIES","customerCountry":"NEPAL","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"13750","totalValueFC":"1649.1","currency":"INR","unitRateINR":13857.210000000001,"date":"18-Oct-2024","totalValueINR":"138572.1","totalValueInUsd":"1649.1","indian_port":"Sonauli","hs_no":"29242190","bill_no":"4927347","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Sonauli","supplierAddress":"44-FAIZ-E-EDROOS,371-373, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"TORSEMIDE USP","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"MEDICA PHARMACEUTICAL AND CHEMICAL","customerCountry":"JORDAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"315","totalValueFC":"265.5","currency":"EUR","unitRateINR":22308.25,"date":"21-Oct-2024","totalValueINR":"22308.25","totalValueInUsd":"265.5","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"4989687","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"TORSEMIDE USP 43","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"AL ANDALOUS FOR ","customerCountry":"EGYPT","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"300","totalValueFC":"5275","currency":"USD","unitRateINR":24624.277777777777,"date":"23-Oct-2024","totalValueINR":"443237","totalValueInUsd":"5275","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"5071103","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"DRUGS: TORASEMIDE \/ TORSEMIDE USP","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"IPCA LABORATORIES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"OF","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"275","totalValueFC":"13399.4","currency":"USD","unitRateINR":22614.9666,"date":"11-Nov-2024","totalValueINR":"1130748.33","totalValueInUsd":"13399.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"5513958","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"48, KANDIVLI INDUSTRIAL ESTATE,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"PHARMACEUTICAL RAW MATERIAL TORSEMIDE USP (TAX INVOICE NO:-EXP\/24-25\/104)CAS NUMBER : (56211-40-6) BATCH NO: TRS\/011\/07\/","address":"PLOT NO 7407 , B\/H LYKA LAB","city":"N\/A","supplier":"PRUDENCE PHARMA CHEM","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"TO THE ORDER OF,","customerCountry":"JORDAN","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"185","totalValueFC":"1817.6","currency":"USD","unitRateINR":15338.102999999999,"date":"28-Nov-2024","totalValueINR":"153381.03","totalValueInUsd":"1817.6","indian_port":"Bombay Air","hs_no":"29242190","bill_no":"5991993","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO 7407 , B\/H LYKA LAB, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733077800,"product":"TORSEMIDE USP (TAX INV#KHPL\/24-25\/E-024 DT:30.11.2024)","address":"52-A, JAROD-SAMLAYA ROAD, GARDHIYA,","city":"N\/A","supplier":"KALINTIS HEALTHCARE","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"TO THE ORDER OF. .","customerCountry":"UNITED STATES","quantity":"294.31","actualQuantity":"294.31","unit":"KGS","unitRateFc":"350","totalValueFC":"97695.1","currency":"USD","unitRateINR":28205.130542625124,"date":"02-Dec-2024","totalValueINR":"8301051.97","totalValueInUsd":"97695.1","indian_port":"Bombay Air","hs_no":"29355090","bill_no":"6084804","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"52-A, JAROD-SAMLAYA ROAD, GARDHIYA,, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"PHARMACEUTICAL RAW MATERIAL H.S.CODE NO-29242190 TORSEMIDE USP","address":"16, NADIRSHA SUKHIA STREET,","city":"MUMBAI ,MAHARASHTRA","supplier":"EUROASIA TRANS CONTINENTAL","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"TO THE ORDER","customerCountry":"JORDAN","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"126.7","totalValueFC":"37678.5","currency":"USD","unitRateINR":10671.666666666666,"date":"20-Dec-2024","totalValueINR":"3201500","totalValueInUsd":"37678.5","indian_port":"Bombay Air","hs_no":"29242190","bill_no":"6635844","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"16, NADIRSHA SUKHIA STREET,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693938600,"product":"TORSEMIDE (QTY:1 X 200 MG, VALUE: USD 265) (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":"0.0002","unit":"KGS","unitRateFc":"1325000","totalValueFC":"278.5","currency":"USD","unitRateINR":"115591450","date":"06-Sep-2023","totalValueINR":"23118.29","totalValueInUsd":"278.5","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"7708253","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. 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    11-Jan-2021
    20-Dec-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20136

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    DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20136

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    DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20136

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    DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20136

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    ABOUT THIS PAGE

    Torsemide Manufacturers

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

    Torsemide Suppliers

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

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

    Torsemide USDMF

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

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

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

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

    Torsemide KDMF

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

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

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

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

    Torsemide CEP

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

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

    Torsemide WC

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

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

    Torsemide 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 Torsemide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Torsemide GMP

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

    Torsemide CoA

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

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

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