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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.


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LABORATORIES","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"OF","customerCountry":"RUSSIA","quantity":"230.00","actualQuantity":"230","unit":"KGS","unitRateFc":"285","totalValueFC":"63643.4","currency":"USD","unitRateINR":23968,"date":"27-Mar-2025","totalValueINR":"5512640","totalValueInUsd":"63643.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"9432373","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"48, KANDIVLI INDUSTRIAL ESTATE,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"DRUGS: TORASEMIDE \/ TORSEMIDE USP","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"IPCA 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","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"720","totalValueFC":"4351.1","currency":"USD","unitRateINR":"59470.9","date":"07-Aug-2023","totalValueINR":"360429.696","totalValueInUsd":"4351.1","indian_port":"SAHAR AIR","hs_no":"29335990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"204, ANAND ESTATES, 189, ARTHUR ,ROAD, CHINCKPOKLI, , ,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693938600,"product":"TORSEMIDE RELATED COMPOUND E (QTY:2 X 20 MG, VALUE: USD 903\/EACH) (FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"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. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693938600,"product":"TORSEMIDE RELATED COMPOUND B (QTY:1 X 50 MG, VALUE: USD 838)(FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741977000,"product":"115224002 TORSEMIDE USP 115224002 TORSEMIDE USP","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"COSMA SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"650","totalValueFC":"26354.9","currency":"USD","unitRateINR":"57070","date":"15-Mar-2025","totalValueINR":"2282800","totalValueInUsd":"26354.9","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"8893191","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"SOCIETA CON SOCIO UNICO VIA COLLEON I, 15\/17 - 24040 CISERANO (BG) ITAL Y Italy","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"}]
22-Jan-2021
29-Mar-2025
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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

Looking for 56211-40-6 / Torsemide API manufacturers, exporters & distributors?

Torsemide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Torsemide

Synonyms

Torasemide, 56211-40-6, Demadex, Luprac, Torasemida, Torasemidum

Cas Number

56211-40-6

Unique Ingredient Identifier (UNII)

W31X2H97FB

About 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.

Torem Manufacturers

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

Torem Suppliers

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

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

Torem USDMF

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

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

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

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

Torem KDMF

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

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

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

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

Torem CEP

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

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

Torem WC

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

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

Torem 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 Torem as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Torem GMP

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

Torem CoA

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

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

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