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Chemistry

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Also known as: 28395-03-1, 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid, Bumex, Burinex, Fordiuran, Lunetoron
Molecular Formula
C17H20N2O5S
Molecular Weight
364.4  g/mol
InChI Key
MAEIEVLCKWDQJH-UHFFFAOYSA-N
FDA UNII
0Y2S3XUQ5H

Bumetanide
A sulfamyl diuretic.
Bumetanide is a Loop Diuretic. The physiologic effect of bumetanide is by means of Increased Diuresis at Loop of Henle.
1 2D Structure

Bumetanide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid
2.1.2 InChI
InChI=1S/C17H20N2O5S/c1-2-3-9-19-14-10-12(17(20)21)11-15(25(18,22)23)16(14)24-13-7-5-4-6-8-13/h4-8,10-11,19H,2-3,9H2,1H3,(H,20,21)(H2,18,22,23)
2.1.3 InChI Key
MAEIEVLCKWDQJH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCNC1=C(C(=CC(=C1)C(=O)O)S(=O)(=O)N)OC2=CC=CC=C2
2.2 Other Identifiers
2.2.1 UNII
0Y2S3XUQ5H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bumedyl

2. Bumethanide

3. Bumex

4. Burinex

5. Drenural

6. Fordiuran

7. Miccil

8. Pf 1593

9. Pf-1593

10. Pf1593

2.3.2 Depositor-Supplied Synonyms

1. 28395-03-1

2. 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic Acid

3. Bumex

4. Burinex

5. Fordiuran

6. Lunetoron

7. Fontego

8. Segurex

9. Ro 10-6338

10. Bumetanida

11. Bumetanidum

12. Bumetanidum [inn-latin]

13. Pf 1593

14. Bumetanida [inn-spanish]

15. 3-(aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic Acid

16. Benzoic Acid, 3-(aminosulfonyl)-5-(butylamino)-4-phenoxy-

17. Bumetanide (ro 10-6338)

18. 0y2s3xuq5h

19. Ro-10-6338

20. Mls000028457

21. Chebi:3213

22. Aquazone

23. Butinat

24. Cambiex

25. Diurama

26. Yurinex

27. Benzoic Acid, 3-(butylamino)-4-phenoxy-5-sulfamoyl-

28. Burine

29. 3-butylamino-4-phenoxy-5-sulfamoyl-benzoic Acid

30. 3-butylamino-4-(phenoxy)-5-sulfamoylbenzoic Acid

31. Lixil-leo

32. Ro-106338

33. Ncgc00015149-02

34. Smr000058418

35. Lixil

36. Cas-28395-03-1

37. Ro 10-6338;pf 1593

38. Dsstox_cid_2699

39. 3-butylamino-4-phenoxy-5-sulfamoylbenzoic Acid

40. Dsstox_rid_76695

41. Dsstox_gsid_22699

42. S95008.

43. S-95008.

44. Bufenox

45. Bumex (tn)

46. Sr-01000003062

47. Einecs 249-004-6

48. Unii-0y2s3xuq5h

49. Brn 2185351

50. Bumetanide In Bulk

51. 82u

52. Prestwick_679

53. Mfcd00078949

54. Bumetanide [usan:usp:inn:ban:jan]

55. Spectrum_001317

56. Bumetanide, >=98%

57. Bumetanide [mi]

58. Bumetanide [inn]

59. Bumetanide [jan]

60. Opera_id_1734

61. Prestwick0_000276

62. Prestwick1_000276

63. Prestwick2_000276

64. Prestwick3_000276

65. Spectrum2_001050

66. Spectrum3_001481

67. Spectrum4_000030

68. Spectrum5_001212

69. Bumetanide [usan]

70. Lopac-b-3023

71. Bumetanide [vandf]

72. B 3023

73. Bumetanide [mart.]

74. Cid_2471

75. Bumetanide [usp-rs]

76. Bumetanide [who-dd]

77. Chembl1072

78. Lopac0_000162

79. Schembl27525

80. Bspbio_000152

81. Bspbio_001508

82. Bspbio_003061

83. Kbiogr_000228

84. Kbiogr_000439

85. Kbioss_000228

86. Kbioss_001797

87. 3-(butylamino)-4-phenoxy-5-sulfamoyl-benzoic Acid

88. Mls001148265

89. Divk1c_000034

90. Spectrum1502004

91. Spbio_000980

92. Spbio_002371

93. Bpbio1_000168

94. Bumetanide (jp17/usp/inn)

95. Gtpl4837

96. Bumetanide [ep Impurity]

97. Bumetanide [orange Book]

98. Dtxsid5022699

99. Bdbm25903

100. Hms500b16

101. Kbio1_000034

102. Kbio2_000228

103. Kbio2_001797

104. Kbio2_002796

105. Kbio2_004365

106. Kbio2_005364

107. Kbio2_006933

108. Kbio3_000455

109. Kbio3_000456

110. Kbio3_002561

111. Bumetanide [ep Monograph]

112. Ninds_000034

113. 3-(aminosulfonyl)-5-(butylamino)-4-(phenyloxy)benzoic Acid

114. Bio1_000421

115. Bio1_000910

116. Bio1_001399

117. Bio2_000228

118. Bio2_000708

119. Bumetanide [usp Monograph]

120. Hms1361l10

121. Hms1568h14

122. Hms1791l10

123. Hms1921b20

124. Hms1989l10

125. Hms2089p13

126. Hms2092n03

127. Hms2095h14

128. Hms2230p15

129. Hms3259o08

130. Hms3260b05

131. Hms3374e02

132. Hms3402l10

133. Hms3654b13

134. Hms3712h14

135. Hms3873c13

136. Pharmakon1600-01502004

137. Bcp28485

138. Zinc3813061

139. Tox21_110088

140. Tox21_500162

141. Ccg-40125

142. Nsc758145

143. S1287

144. Akos015896600

145. Tox21_110088_1

146. Ac-8115

147. Cs-1821

148. Db00887

149. Ks-5211

150. Lp00162

151. Nc00550

152. Nsc 758145

153. Nsc-758145

154. Sdccgsbi-0050150.p004

155. Idi1_000034

156. Idi1_033978

157. Smp1_000049

158. Ncgc00015149-01

159. Ncgc00015149-03

160. Ncgc00015149-04

161. Ncgc00015149-05

162. Ncgc00015149-06

163. Ncgc00015149-07

164. Ncgc00015149-08

165. Ncgc00015149-09

166. Ncgc00015149-10

167. Ncgc00015149-11

168. Ncgc00015149-12

169. Ncgc00015149-13

170. Ncgc00015149-15

171. Ncgc00015149-16

172. Ncgc00015149-26

173. Ncgc00022072-03

174. Ncgc00022072-04

175. Ncgc00022072-05

176. Ncgc00022072-06

177. Ncgc00022072-07

178. Ncgc00022072-08

179. Ncgc00260847-01

180. Hy-17468

181. Sbi-0050150.p003

182. Ab00052253

183. Eu-0100162

184. Sw196834-3

185. D00247

186. 3-butylamino-4-phenoxy-5-sulphamyl-benzoic Acid

187. Ab00052253-15

188. Ab00052253-16

189. Ab00052253_17

190. Ab00052253_18

191. 3-n-butylamino-4-phenoxy-5-sulfamyl-benzoic Acid

192. 3-n-butylamino-4-phenoxy-5-sulphamyl-benzoic Acid

193. 395b031

194. A819434

195. Q275926

196. J-017055

197. Sr-01000003062-2

198. Sr-01000003062-4

199. Sr-01000003062-7

200. Brd-k38197229-001-06-7

201. Brd-k38197229-001-17-4

202. 3-(aminosulfonyl)-5-(butylamino)-4-phenoxy-benzoic Acid

203. Z1550648769

204. 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic Acid.

205. Bumetanide, British Pharmacopoeia (bp) Reference Standard

206. Bumetanide, European Pharmacopoeia (ep) Reference Standard

207. Bumetanide, United States Pharmacopeia (usp) Reference Standard

208. Ro 10-6338; Pf 1593 Pound>>ro-10-6338; Pf1593 Pound>>ro10-6338; Pf-1593

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 364.4 g/mol
Molecular Formula C17H20N2O5S
XLogP32.8
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count8
Exact Mass364.10929292 g/mol
Monoisotopic Mass364.10929292 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count25
Formal Charge0
Complexity528
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 NameBumetanide
PubMed HealthBumetanide
Drug ClassesCardiovascular Agent, Diuretic, Loop
Drug LabelBumetanide is a loop diuretic, available as scored tablets, 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) for oral administration; each tablet also contains: anhydrous lactose, magnesium stearate, microcrystalline cellulose, corn starch and ta...
Active IngredientBumetanide
Dosage FormInjectable; Tablet
RouteInjection; Oral
Strength0.5mg; 2mg; 1mg; 0.25mg/ml
Market StatusPrescription
CompanyBedford; Ivax Sub Teva Pharms; Hospira; Hikma Maple; Sandoz

2 of 2  
Drug NameBumetanide
PubMed HealthBumetanide
Drug ClassesCardiovascular Agent, Diuretic, Loop
Drug LabelBumetanide is a loop diuretic, available as scored tablets, 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) for oral administration; each tablet also contains: anhydrous lactose, magnesium stearate, microcrystalline cellulose, corn starch and ta...
Active IngredientBumetanide
Dosage FormInjectable; Tablet
RouteInjection; Oral
Strength0.5mg; 2mg; 1mg; 0.25mg/ml
Market StatusPrescription
CompanyBedford; Ivax Sub Teva Pharms; Hospira; Hikma Maple; Sandoz

4.2 Drug Indication

For the treatment of edema associated with congestive heart failure, hepatic and renal disease including the nephrotic syndrome.


FDA Label


Treatment of autism spectrum disorder


5 Pharmacology and Biochemistry
5.1 Pharmacology

Bumetanide is a loop diuretic of the sulfamyl category to treat heart failure. It is often used in patients in whom high doses of furosemide are ineffective. There is however no reason not to use bumetanide as a first choice drug. The main difference between the two substances is in bioavailability. Bumetanide has more predictable pharmacokinetic properties as well as clinical effect. In patients with normal renal function, bumetanide is 40 times more effective than furosemide.


5.2 MeSH Pharmacological Classification

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
BUMETANIDE
5.3.2 FDA UNII
0Y2S3XUQ5H
5.3.3 Pharmacological Classes
Loop Diuretic [EPC]; Increased Diuresis at Loop of Henle [PE]
5.4 ATC Code

C03CA02

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

C03CA02 - Bumetanide


5.5 Absorption, Distribution and Excretion

Absorption

Bumetanide is completely absorbed (80%), and the absorption is not altered when taken with food. Bioavailability is almost complete.


Route of Elimination

Oral administration of carbon-14 labeled Bumex to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Biliary excretion of Bumex amounted to only 2% of the administered dose.


Clearance

0.2 - 1.1 mL/min/kg [preterm and full-term neonates with respiratory disorders]

2.17 mL/min/kg [neonates receiving bumetanide for volume overload]

1.8 +/- 0.3 mL/min/kg [geriatric subjects]

2.9 +/- 0.2 mL/min/kg [younger subjects]


5.6 Metabolism/Metabolites

45% is secreted unchanged. Urinary and biliary metabolites are formed by oxidation of the N-butyl side chain.


5.7 Biological Half-Life

60-90 minutes


5.8 Mechanism of Action

Bumetanide interferes with renal cAMP and/or inhibits the sodium-potassium ATPase pump. Bumetanide appears to block the active reabsorption of chloride and possibly sodium in the ascending loop of Henle, altering electrolyte transfer in the proximal tubule. This results in excretion of sodium, chloride, and water and, hence, diuresis.


API Reference Price

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ROAD JOGESHWARI WEST Contact No: 9198677"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677263400,"product":"BUMETANIDE MICRO EP\/USP","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"6000","totalValueFC":"3038.5","currency":"USD","unitRateINR":"501900","date":"25-Feb-2023","totalValueINR":"250950","totalValueInUsd":"3038.5","indian_port":"HYDERABAD AIR","hs_no":"29359090","bill_no":"4805220","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684521000,"product":"BUMETANIDE MICRO EP\/USP","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"7250","totalValueFC":"587160","currency":"USD","unitRateINR":"603925","date":"20-May-2023","totalValueINR":"48314000","totalValueInUsd":"587160","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29359090","bill_no":"1002108","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI: STR, RIVOLTANA KM 6\/7 20090 RODANO (MI) 0","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686767400,"product":"BUMETANIDE USP","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. 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CHEMO IBERICA, S.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.68","actualQuantity":"0.68","unit":"KGS","unitRateFc":"9000","totalValueFC":"6193.1","currency":"USD","unitRateINR":"759150","date":"30-May-2024","totalValueINR":"516222","totalValueInUsd":"6193.1","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"3740590","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RD FLOOR28050 MADRID -SPAINSDNF ES","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717353000,"product":"BUMETANIDE -USP\/EP-2610500 (ACTIVE PHARMACEUTICAL INGREDIENTS)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"10000","totalValueFC":"303128.6","currency":"USD","unitRateINR":"843500","date":"03-Jun-2024","totalValueINR":"25305000","totalValueInUsd":"303128.6","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"3807512","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STR. RIVOLTANA KM 6\/7 20053 RODANO(MI) ITALY. ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717439400,"product":"(FOC) - BUMETANIDE USP INJECTABLE GRADE - 2610500 - 0024100724","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"35000","totalValueFC":"123777.5","currency":"USD","unitRateINR":"2952250","date":"04-Jun-2024","totalValueINR":"10332875","totalValueInUsd":"123777.5","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"3823886","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Sterile","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM6\/7 20053 RODANO (MI) Milano, , Italy Italy","customerAddress":"REGD. 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K","supplierAddress":"113, CONNCECTICUT COMPLEXPLATTSBURGH NY12903 US","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721327400,"product":"BUMETANIDE USP","address":"1\/5, SANTOSH COMPLEX, ARMUGAM","city":"BANGALORE , KARNATAKA","supplier":"SAGENT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"MAIVA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2.000537","unit":"KGS","unitRateFc":"21000","totalValueFC":"42443","currency":"USD","unitRateINR":"1773450","date":"19-Jul-2024","totalValueINR":"3547852.34","totalValueInUsd":"42443","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"4587462","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. 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ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"BUMETANIDE MICRO EP USP BUMETANIDE MICRO EP USP","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"7250","totalValueFC":"146566.7","currency":"USD","unitRateINR":"618425","date":"15-Nov-2024","totalValueINR":"12368500","totalValueInUsd":"146566.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29359090","bill_no":"6686358","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"STR. 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Dublin, , Ireland Ireland","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"}]
10-Feb-2021
06-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 18225

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DOSAGE - TABLET;ORAL - 1MG

USFDA APPLICATION NUMBER - 18225

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DOSAGE - TABLET;ORAL - 2MG

USFDA APPLICATION NUMBER - 18225

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ABOUT THIS PAGE

Bumetanide Manufacturers

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

Bumetanide Suppliers

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

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

Bumetanide USDMF

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

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

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

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

Bumetanide CEP

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

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

Bumetanide WC

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

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

Bumetanide 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 Bumetanide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bumetanide GMP

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

Bumetanide CoA

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

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

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