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Athena Amphotericin B

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Chemwerth Amphotericin B

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 13 USDMF, 4 CEP/COS, 3 JDMF, 1 EU WC, 3 KDMF, 11 NDC API, 16 Listed Suppliers, $ API Reference Price

31 API Suppliers
13 USDMF
4 CEP/COS
3 JDMF
1 EU WC
3 KDMF
11 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 15 FDA Orange Book, 14 Europe, 2 Canada, 2 Australia, 3 South Africa, 12 Listed Dossiers

48 FDF Dossiers
15 FDA Orange Book
14 Europe
2 Canada
2 Australia
3 South Africa
12 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Actylis

relatedExcipients
2 Actylis

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 43 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
43 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 9 Finished Drug Prices, 22 Annual Reports

globalSalesInformation
4 US Medicaid Prescriptions
9 Finished Drug Prices
22 Annual Reports

MARKET PLACE

26 APIs, 19 FDF Dossiers

marketPlace
26 APIs
19 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 1 Others

otherSolutions
3 EDQM
1 USP
1 Others

Athena Amphotericin B

Synopsis

ACTIVE PHARMA INGREDIENTS

31

API Suppliers

13

USDMF

4

CEP/COS

CEP/COS Certifications

3

JDMF

1

EU WC

3

KDMF

11

NDC API

0

VMF

16

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 13,654

MARKET PLACE

26

API

19

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

48

FDF Dossiers

15

FDA Orange Book

FDA (Orange Book)

14

Europe

2

Canada

2

Australia

3

South Africa

12

Listed Dossiers

16DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

1

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

4

Health Canada Patents

DIGITAL CONTENT

2

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

43

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

2,760,474

Annual Reports (USD Million)

4,899

Finished Drug Prices

2 RELATED EXCIPIENT COMPANIES

2EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1397-89-3, Amphotericin, Amphotericine b, Fungizone, Ambisome, Ampho-moronal

Molecular Formula

C₄₇H₇₃NO₁₇

Molecular Weight

924.1 g/mol

InChI Key

APKFDSVGJQXUKY-INPOYWNPSA-N

FDA UNII

7XU7A7DROE

Amphotericin B

Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.

Amphotericin b is a Lipid-based Polyene Antifungal and Polyene Antifungal.

1 2D Structure

Amphotericin B

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid

2.1.2 InChI

InChI=1S/C47H73NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-33(51)22-36(53)35(52)20-19-31(49)21-32(50)23-39(55)62-29(3)28(2)42(27)56/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60)/b6-5+,9-7+,10-8+,13-11+,14-12+,17-15+,18-16+/t27-,28-,29-,30+,31+,32+,33-,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1

2.1.3 InChI Key

APKFDSVGJQXUKY-INPOYWNPSA-N

2.1.4 Canonical SMILES

CC1C=CC=CC=CC=CC=CC=CC=CC(CC2C(C(CC(O2)(CC(CC(C(CCC(CC(CC(=O)OC(C(C1O)C)C)O)O)O)O)O)O)O)C(=O)O)OC3C(C(C(C(O3)C)O)N)O

2.1.5 Isomeric SMILES

C[C@H]1/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@@H](C[C@H]2[C@@H]([C@H](C[C@](O2)(C[C@H](C[C@H]([C@@H](CC[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]1O)C)C)O)O)O)O)O)O)O)C(=O)O)O[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)O)N)O

2.2 Other Identifiers

2.2.1 UNII

7XU7A7DROE

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Amphocil

2. Amphotericin

3. Amphotericin B Cholesterol Dispersion

4. Amphotericin B Colloidal Dispersion

5. Fungizone

2.3.2 Depositor-Supplied Synonyms

1. 1397-89-3

2. Amphotericin

3. Amphotericine B

4. Fungizone

5. Ambisome

6. Ampho-moronal

7. Halizon

8. Amfotericina B

9. Amphotericinum B

10. Amph-b

11. Liposomal Amphotericin B

12. Amphotericin-b

13. Abelcet

14. Amphotec

15. Fungilin

16. Mfcd00877763

17. 7xu7a7droe

18. Nsc 527017

19. Ncgc00090808-01

20. Dsstox_cid_2601

21. Dsstox_rid_76653

22. Amphotocerin

23. Dsstox_gsid_22601

24. Ambil

25. Ablc

26. Abelecet

27. Amphortericin B

28. Anfotericine B

29. Amphotericin B Liposome

30. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-(((2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic Acid

31. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic Acid

32. Amphotericin B Liposomal

33. Amphotericin B Trihydrate

34. Iab

35. Unii-7xu7a7droe

36. Fungisome

37. Amfotericina B [inn-spanish]

38. Amphotericine B [inn-french]

39. Amphotericinum B [inn-latin]

40. Ccris 5963

41. Hsdb 3008

42. Amphotericin B [usp:inn:jan]

43. Nsc-527017

44. Fungizone (tn)

45. Amphotec (tn)

46. (1s,3r,4e,6e,8e,10e,12e,14e,16e,18s,19r,20r,21s,25r,27r,30r,31r,33s,35r,37s,38r)-3-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyl-tetrahydropyran-2-yl]oxy-19,25,27,30,31,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,12,14,16-heptaene-38-carboxylic Acid

47. Ambisome (tn)

48. Amp B

49. Cas-1397-89-3

50. Einecs 215-742-2

51. Ns 718

52. Brn 0078342

53. Ai3-26528

54. Prestwick3_000410

55. Amphotericin B (85%)

56. Amphotericin B Solubilized

57. Amphotericin B [mi]

58. Schembl17973

59. Amphotericin B [inn]

60. Amphotericin B [jan]

61. Bspbio_000340

62. 5-18-10-00525 (beilstein Handbook Reference)

63. Amphotericin B [hsdb]

64. Bidd:gt0351

65. Amphotericin B [vandf]

66. Bpbio1_000374

67. Nktr-024

68. Amphotericin B [mart.]

69. Amphotericin B And Cinnamon Oil

70. Amphotericin B [usp-rs]

71. Amphotericin B [who-dd]

72. Amphotericin B [who-ip]

73. Dtxsid9022601

74. Hms2096a22

75. Hms3713a22

76. Amphotericin B (jp17/usp/inn)

77. Hy-b0221

78. Amphotericin B, Streptomyces Nodosus

79. Tox21_111027

80. Tox21_202484

81. Amphotericin B [orange Book]

82. Lmpk06000002

83. S1636

84. Amphotericin B [ep Monograph]

85. Akos024464746

86. Amphotericin B [usp Monograph]

87. Zinc253387843

88. Amphotericin B Liposome [vandf]

89. Ccg-220410

90. Db00681

91. Amphotericinum B [who-ip Latin]

92. Abelcet, Liposomal Amphotericin B

93. Ncgc00260033-01

94. (1r-(1r*,3s*,5r*,6r*,9r*,11r*,15s*,16r*,17r*,18s*,19e,21e,23e,25e,27e,29e,31e,33r*,35s*,36r*,37s*))-33-((3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo(33.3.1)nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic Acid

95. 14,39-dioxabicyclo(33.3.1)nonatriaconta-19,21,23,25,2 7,29,31-heptaene-36-carboxylic Acid, 33-((3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-(1r-(1r*,3s*,5r*,6r*,9r*,11r*,15s*,16r*,17r*,18s*,19e,21e,23e, 25e-27e,29e,31e,33r*,35s*,36r*,37s*))-

96. Amphotericin B Lipid Complex [mi]

97. Ab00513832

98. Amphotericin B Deoxycholate [who-dd]

99. Amphotericin B Lipid Complex [vandf]

100. Amphotericin B Liposomal Complex [mi]

101. C06573

102. D00203

103. Ab00513832_02

104. 397a893

105. Q412223

106. 1397-89-3, C47h73no17

107. Amphotericin B From Streptomyces Sp., ~80% (hplc), Powder

108. Amphotericin B From Streptomyces Sp., Bioreagent, Suitable For Cell Culture, ~80% (hplc)

109. Amphotericin B Solubilized, Powder, Gamma-irradiated, Bioxtra, Suitable For Cell Culture

110. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,

111. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic Acid

112. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(3-amino-3,6-dideoxy-?-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic Acid

113. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-he

114. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,19e,21e,23e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-hept

115. (1r,3s,5r,6r,9r,11r,15s,16r,17r,18s,33r,35s,36r,37s)-33-{[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy}-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carbo

116. (1s,3r,4e,6e,8e,10e,12e,14e,16e,18s,19r,20r,21s,25r,27r,30r,31r,33s,35r,37s,38r)-3-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-19,25,27,30,31,33,35,37-octahydroxy-18,20,21-trimethyl-

117. 23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,12,14,16-heptaene-38-carboxylic Acid

118. Amphotericin B From Streptomyces Sp., Vetec(tm) Reagent Grade, Bioreagent, Suitable For Cell Culture, ~80%

119. Amphotericin B Solution, 250 Mug/ml In Deionized Water, Sterile-filtered, Bioreagent, Suitable For Cell Culture

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₄₇H₇₃NO₁₇
Molecular Weight	924.1 g/mol
XLogP3	0
Hydrogen Bond Donor Count	12
Hydrogen Bond Acceptor Count	18
Rotatable Bond Count	3
Exact Mass	923.48784986 g/mol
Monoisotopic Mass	923.48784986 g/mol
Topological Polar Surface Area	320 Å²
Heavy Atom Count	65
Formal Charge	0
Complexity	1670
Isotope Atom Count	0
Defined Atom Stereocenter Count	19
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	7
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Abelcet
PubMed Health	Amphotericin B Lipid Complex (Injection)
Drug Classes	Antifungal, Antiprotozoal
Active Ingredient	Amphotericin b
Dosage Form	Injectable, lipid complex
Route	Injection
Strength	5mg/ml
Market Status	Prescription
Company	Sigma Tau

2 of 8
Drug Name	Ambisome
PubMed Health	Amphotericin B Liposome (Injection)
Drug Classes	Antifungal, Antiprotozoal
Active Ingredient	Amphotericin b
Dosage Form	Injectable, liposomal
Route	Injection
Strength	50mg/vial
Market Status	Prescription
Company	Astellas

3 of 8
Drug Name	Amphotec
PubMed Health	Amphotericin B Cholesteryl Sulfate Complex (Injection)
Drug Classes	Antifungal, Antiprotozoal
Drug Label	AMPHOTEC is a sterile, pyrogen-free, lyophilized powder for reconstitution and intravenous (IV) administration. AMPHOTEC consists of a 1:1 (molar ratio) complex of amphotericin B and cholesteryl sulfate. Upon reconstitution, AMPHOTEC forms a colloi...
Active Ingredient	Amphotericin b
Dosage Form	Injectable, lipid complex
Route	Injection
Strength	100mg/vial; 50mg/vial
Market Status	Prescription
Company	Alkopharma Usa

4 of 8
Drug Name	Amphotericin b
PubMed Health	Amphotericin B (Injection)
Drug Classes	Antifungal, Antiprotozoal
Drug Label	Amphotericin B for Injection USP contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R- (1R, 3S, 5R, 6R, 9R, 11R, 15S, 16R, 17R, 18S, 19E, 21...
Active Ingredient	Amphotericin b
Dosage Form	Injectable
Route	Injection
Strength	50mg/vial
Market Status	Prescription
Company	X Gen Pharms

5 of 8
Drug Name	Abelcet
PubMed Health	Amphotericin B Lipid Complex (Injection)
Drug Classes	Antifungal, Antiprotozoal
Active Ingredient	Amphotericin b
Dosage Form	Injectable, lipid complex
Route	Injection
Strength	5mg/ml
Market Status	Prescription
Company	Sigma Tau

6 of 8
Drug Name	Ambisome
PubMed Health	Amphotericin B Liposome (Injection)
Drug Classes	Antifungal, Antiprotozoal
Active Ingredient	Amphotericin b
Dosage Form	Injectable, liposomal
Route	Injection
Strength	50mg/vial
Market Status	Prescription
Company	Astellas

7 of 8
Drug Name	Amphotec
PubMed Health	Amphotericin B Cholesteryl Sulfate Complex (Injection)
Drug Classes	Antifungal, Antiprotozoal
Drug Label	AMPHOTEC is a sterile, pyrogen-free, lyophilized powder for reconstitution and intravenous (IV) administration. AMPHOTEC consists of a 1:1 (molar ratio) complex of amphotericin B and cholesteryl sulfate. Upon reconstitution, AMPHOTEC forms a colloi...
Active Ingredient	Amphotericin b
Dosage Form	Injectable, lipid complex
Route	Injection
Strength	100mg/vial; 50mg/vial
Market Status	Prescription
Company	Alkopharma Usa

8 of 8
Drug Name	Amphotericin b
PubMed Health	Amphotericin B (Injection)
Drug Classes	Antifungal, Antiprotozoal
Drug Label	Amphotericin B for Injection USP contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R- (1R, 3S, 5R, 6R, 9R, 11R, 15S, 16R, 17R, 18S, 19E, 21...
Active Ingredient	Amphotericin b
Dosage Form	Injectable
Route	Injection
Strength	50mg/vial
Market Status	Prescription
Company	X Gen Pharms

4.2 Therapeutic Uses

Ambecides; Antibiotics, Antifungal; Antibiotics, Macrolide; Antiprotozoal Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

MEDICATION: Antifungal; (VET): Antifungal

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 98

MEDICATION (VET): ... Blastomycosis, histoplasmosis.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 18

Parenteral amphotericin B is used as a secondary agent in the treatment of paracoccidioidomycosis caused by Paracoccidioide brasillensis. /NOT included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 131

For more Therapeutic Uses (Complete) data for AMPHOTERICIN B (19 total), please visit the HSDB record page.

4.3 Drug Warning

Rash (including maculopapular or vesiculobullous rash), purpura, pruritus, urticaria, sweating, exfoliative dermatitis, erythema multiforme, alopecia, dry skin, and skin discoloration or ulcer, have been reported in patients receiving amphotericin B.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 538

IV administration of conventional amphotericin B, amphotericin B cholesteryl sulfate complex, amphotericin B lipid complex, or amphotericin B liposomal may cause erythema, pain, or inflammation at the injection site. Phlebitis or thrombophlebitis has been reported with conventional IV amphotericin B. The manufacturer of conventional IV amphotericin B and some clinicians suggest that the addition of 500-1000 units of heparin to the amphotericin B infusion, the use of a pediatric scalp-vein needle, or alternate-day therapy may decrease the incidence of thrombophlebitis. Extravasation of the drug causes local irritation.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 538

Conventional IV amphotericin B is associated with a high incidence of adverse effects, and most patients who receive the drug experience potentially severe adverse effects at some time during the course of therapy. Acute infusion reactions (e.g., fever, chills, headache, nausea, vomiting) and nephrotoxicity are the most frequent adverse reactions to conventional IV amphotericin B. Although clinical experience with amphotericin B cholesteryl sulfate complex, amphotericin B lipid complex, and amphotericin B liposomal is limited to date, these drugs appear to be better tolerated than conventional IV amphotericin B. As with conventional IV amphotericin B, the most frequent adverse reactions to amphotericin B cholesteryl sulfate complex, amphotericin B lipid complex, or amphotericin B liposomal are acute infusion reactions; however, data accumulated to date indicate that lipid-based and liposomal formulations of amphotericin B may be associated with a lower overall incidence of adverse effects and a lower incidence of hematologic and renal toxicity than the conventional formulation of the drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 537

Acute infusion reactions consisting of fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, dyspnea, and tachypnea may occur 1-3 hours after initiation of IV infusions of conventional amphotericin B, amphotericin B cholesteryl sulfate, amphotericin B lipid complex, or amphotericin B liposomal. These reactions are most severe and occur most frequently with initial doses and usually lessen with subsequent doses. Fever (with or without shaking chills) may occur as soon as 15-20 minutes after IV infusions of conventional amphotericin B are started. The majority of patients receiving conventional IV amphotericin B (50-90%) exhibit some degree of intolerance to initial doses of the drug, even when therapy is initiated with low doses. Although these reactions become less frequent following subsequent doses or administration of the drug on alternate days, they recur if conventional IV amphotericin B therapy is interrupted and then reinstituted.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 537

For more Drug Warnings (Complete) data for AMPHOTERICIN B (18 total), please visit the HSDB record page.

4.4 Drug Indication

Used to treat potentially life threatening fungal infections.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to amphotericin B, non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.

5.2 MeSH Pharmacological Classification

Amebicides

Agents which are destructive to amebae, especially the parasitic species causing AMEBIASIS in man and animal. (See all compounds classified as Amebicides.)

Antiprotozoal Agents

Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

AMPHOTERICIN B

5.3.2 FDA UNII

7XU7A7DROE

5.3.3 Pharmacological Classes

Polyene Antifungal [EPC]; Polyenes [CS]; Lipid-based Polyene Antifungal [EPC]

5.4 ATC Code

A - Alimentary tract and metabolism

A01 - Stomatological preparations

A01A - Stomatological preparations

A01AB - Antiinfectives and antiseptics for local oral treatment

A01AB04 - Amphotericin B

A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07A - Intestinal antiinfectives

A07AA - Antibiotics

A07AA07 - Amphotericin B

G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AA - Antibiotics

G01AA03 - Amphotericin B

J - Antiinfectives for systemic use

J02 - Antimycotics for systemic use

J02A - Antimycotics for systemic use

J02AA - Antibiotics

J02AA01 - Amphotericin B

5.5 Absorption, Distribution and Excretion

Absorption

Bioavailability is 100% for intravenous infusion.

Clearance

39 +/- 22 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 1 mg/kg/day at Day 1]

17 +/- 6 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 1 mg/kg/day 3-20 days later]

51 +/- 44 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 2.5 mg/kg/day at Day 1]

22 +/- 15 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 2.5 mg/kg/day 3-20 days later]

21 +/- 14 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 5 mg/kg/day at Day 1]

11 +/- 6 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 5 mg/kg/day 3-20 days later]

The pharmacokinetics of amphotericin B vary substantially depending on whether the drug is administered as conventional amphotericin B (formulated with sodium desoxycholate), amphotericin B cholesteryl sulfate complex, amphotericin B lipid complex, or amphotericin B liposomal, and pharmacokinetic parameters reported for one amphotericin B formulation should not be used to predict the pharmacokinetics of any other amphotericin B formulation.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

Amphotericin B is poorly absorbed from the GI tract and must be given parenterally to treat systemic fungal infections. In one study, immediately after completion of iv infusion of 30 mg of amphotericin B (administered over a period of several hours), average peak serum concentrations were about 1 ug/ml; when the dose was 50 mg, average peak serum concentrations were approximately 2 ug/ml. Immediately after infusion, no more than 10% of the amphotericin B dose can be accounted for in serum. Average minimum serum concentrations (recorded just prior to the next drug infusion) of approximately 0.4 ug/ml have been reported when doses of 30 mg were given daily or when doses of 60 mg were given every other day.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

Information on the distribution of amphotericin B is limited, although distribution is apparently multicompartmental. The volume of distribution of the drug following administration of conventional amphotericin B has been reported to be 4 L/kg; the volume of distribution at steady state after administration of amphotericin B cholesteryl sulfate is reported to be 3.8-4.1 L/kg. Amphotericin B concentrations attained in inflamed pleura, peritoneum, synovium, and aqueous humor following IV administration of conventional amphotericin B reportedly are about 60% of concurrent plasma concentrations; the drug also is distributed into vitreous humor, pleural, pericardial, peritoneal, and synovial fluid. Amphotericin B reportedly crosses the placenta and low concentrations are attained in amniotic fluid.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

Following IV administration of conventional amphotericin B, CSF concentrations of the drug are approximately 3% of concurrent serum concentrations. To achieve fungistatic CSF concentrations, the drug must usually be administered intrathecally. In patients with meningitis, intrathecal administration of 0.2-0.3 mg of conventional amphotericin B via a subcutaneous reservoir has produced peak CSF concentrations of 0.5-0.8 ug/mL; 24 hours after the dose, CSF concentrations were 0.11-0.29 ug/mL. Amphotericin B is removed from the CSF by arachnoid villi and appears to be stored in the extracellular compartment of the brain, which may act as a reservoir for the drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

For more Absorption, Distribution and Excretion (Complete) data for AMPHOTERICIN B (14 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Exclusively renal

5.7 Biological Half-Life

An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours.

Amphotericin B cholesteryl sulfate complex has a distribution half-life of 3.5 minutes and an elimination half-life of 27.5-28.2 hours. /Amphotericin B cholesteryl sulfate complex/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

Following IV administration of conventional amphotericin B in patients whose renal function is normal prior to therapy, the initial plasma half-life is approximately 24 hours. After the first 24 hours, the rate at which amphotericin B is eliminated decreases and an elimination half-life of approximately 15 days has been reported.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 541

Elimination, half life: Neonates: Variable (range, 18 to 62.5 hours). Children: Variable (range, 5.5 to 40.3 hours). Adults: Approximately 24 hours. Terminal half life: Approximately 15 days. NOTE: There is large interindividual variation among neonates in the elimination of amphotericin B. Amphotericin B may persist in the circulation of neonates for up to 17 days after it has been discontinued.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 131

. The half life of elimination of amphotericin B from the lungs /of rats/ was 4.8 days according to serial sacrifices done after a single dose of 3.2 mg of aerosol doses of amphotericin B per kg.

PMID:2327759 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC171515 Niki Y et al; Antimicrob Agents Chemother 34 (1): 29-32 (1990)

5.8 Mechanism of Action

Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components. Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death.

Amphotericin B usually is fungistatic in action at concentrations obtained clinically, but may be fungicidal in high concentrations or against very susceptible organisms. Amphotericin B exerts its antifungal activity principally by binding to sterols (e.g., ergosterol) in the fungal cell membrane. As a result of this binding, the cell membrane is no longer able to function as a selective barrier and leakage of intracellular contents occurs. Cell death occurs in part as a result of permeability changes, but other mechanisms also may contribute to the in vivo antifungal effects of amphotericin B against some fungi. Amphotericin B is not active in vitro against organisms that do not contain sterols in their cell membranes (eg, bacteria).

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 540

Binding to sterols in mammalian cells (such as certain kidney cells and erythrocytes) may account for some of the toxicities reported with conventional amphotericin B therapy. At usual therapeutic concentrations of amphotericin B, the drug does not appear to hemolyze mature erythrocytes, and the anemia seen with conventional IV amphotericin B therapy may result from the action of the drug on actively metabolizing and dividing erythropoietic cells.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 540

...Nephrotoxicity associated with conventional IV amphotericin B appears to involve several mechanisms, including a direct vasoconstrictive effect on renal arterioles that reduces glomerular and renal tubular blood flow and a lytic action on cholesterol-rich lysosomal membranes of renal tubular cells. ...

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 537

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KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST","city":"MUMBAI,MAHARASHTRA","supplier":"NORTH CHINA PHARMACEUTICAL CO., LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4000","unit":"GMS","unitRateFc":"27.4","totalValueFC":"112098.9","currency":"USD","unitRateINR":"2291.3","date":"11-Jan-2023","totalValueINR":"9165150","totalValueInUsd":"112098.9","indian_port":"MADRAS AIR","hs_no":"29419090","bill_no":"4129531","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679077800,"product":"AMPHOTERICIN B","address":"407\/408 SHARDA CHAMBERS,NEW MARINE LINES","city":"MUMBAI,MAHARASHTRA","supplier":"M\/S. NORTH CHINA PHARMACEUTICAL HUASHENG CO.LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.50","actualQuantity":"4.5","unit":"KGS","unitRateFc":"26500","totalValueFC":"126383.8","currency":"USD","unitRateINR":"2310024.8","date":"18-Mar-2023","totalValueINR":"10395111.49","totalValueInUsd":"126383.8","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"5112453","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"407\/408 SHARDA CHAMBERS,NEW MARINE LINES"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679509800,"product":"HIAB-AMPB-C018-N AMPHOTERICIN B (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"4.70","actualQuantity":"4700","unit":"GMS","unitRateFc":"34","totalValueFC":"162616.4","currency":"USD","unitRateINR":"2845.8","date":"23-Mar-2023","totalValueINR":"13375260","totalValueInUsd":"162616.4","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29420090","bill_no":"1000129","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"1764 LITCHFIELD TURNPIKE, SUITE 202 WOODBRIDGE, CT, 06525, USA. United States","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692210600,"product":"AMPHOTERICIN B USP NST 1 KA","address":"SPARC, TANDALJA,,, , ,,","city":"VADODARA","supplier":"M S XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGA","unitRateFc":"33070","totalValueFC":"670845.2","currency":"USD","unitRateINR":"2750732","date":"17-Aug-2023","totalValueINR":"55570343.71","totalValueInUsd":"670845.2","indian_port":"SAHAR AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC, TANDALJA,,, , ,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704220200,"product":"AMPHOTERICIN B [AMPHOTERICIN B USP NST] ( 7 NOS) (QTY : 6.629 KGS)","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"6.63","actualQuantity":"6.629","unit":"KGS","unitRateFc":"47518.5","totalValueFC":"317669.2","currency":"USD","unitRateINR":"3982807.1","date":"03-Jan-2024","totalValueINR":"26402028","totalValueInUsd":"317669.2","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9518060","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"DALSLANDSGADE 11, DK 2300 COPENHAGEN S DENMARK Copenhagen, , DenmarkSDNF Denmark","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707071400,"product":"AMPHOTERICIN B IP (LIST-3, SR NO.2)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"NORTH CHINA PHARMACEUTICAL CO., LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CIPLA","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"8500","totalValueFC":"49070.6","currency":"USD","unitRateINR":"814315","date":"05-Feb-2024","totalValueINR":"4071575","totalValueInUsd":"49070.6","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"9994291","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.8, YANGZI ROAD, ECONOMIC &TECHNOLOGICAL DEVELOPMENT ZONESHIJIAZHUANG, HEBEI CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709749800,"product":"AMPHOTERICIN B","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"BIOBETTA LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"29266","totalValueFC":"29570.6","currency":"USD","unitRateINR":"2455417.4","date":"07-Mar-2024","totalValueINR":"2455417.4","totalValueInUsd":"29570.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2468169","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"SUITE 506-507 BUILDING 35 HH PARK NO.2777SDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710095400,"product":"AMPHOTERICIN B (QTY. 3000 GRAM)","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"CHEMWERTH WOODBRIDGE","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"31000","totalValueFC":"96825.7","currency":"USD","unitRateINR":"2680000","date":"11-Mar-2024","totalValueINR":"8040000","totalValueInUsd":"96825.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2522796","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"1764 LITCHFIELD TURNPIKE SUITE 202WOODBRIDGE CT 06525 USA Woodbridge,, United States United States","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712082600,"product":"AMPHOTERICIN B USP NST 0.100KA A196092 (BATCH NO A1962250) (QTY 1)","address":"UNIT NO.703 704,7TH FLOOR,HUBTOWN","city":"MUMBAI","supplier":"XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"INVENTIA HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.096","unit":"KGS","unitRateFc":"57291.7","totalValueFC":"5592.8","currency":"USD","unitRateINR":"4865000","date":"03-Apr-2024","totalValueINR":"467040","totalValueInUsd":"5592.8","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"2857424","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"Dalslandsgade, 11 DK-2300 Copenhagen SSDNF DENMARK","customerAddress":"UNIT NO.703 704,7TH FLOOR,HUBTOWN"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718130600,"product":"AMPHOTERICIN B IP (LIST-3, SR NO.2)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"NORTH CHINA PHARMACEUTICAL CO., LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CIPLA","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"8500","totalValueFC":"43389.5","currency":"USD","unitRateINR":"724425.3","date":"12-Jun-2024","totalValueINR":"3622126.7","totalValueInUsd":"43389.5","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3953222","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.8, YANGZI ROAD, ECONOMIC &TECHNOLOGICAL DEVELOPMENT ZONESHIJIAZHUANG, HEBEI CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718994600,"product":"AMPHOTERICIN B","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"BIOBETTA LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"29000","totalValueFC":"29285.1","currency":"USD","unitRateINR":"2444700","date":"22-Jun-2024","totalValueINR":"2444700","totalValueInUsd":"29285.1","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"4125516","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"SUITE 506-507 BUILDING 35 HH PARK NO .2777 EAST JINXIU ROADSDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719945000,"product":"AMPHOTERICIN B [AMPHOTERICIN B USP NST] ( 13 NOS) (QTY : 12 .332 KGS)","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"N\/A","supplierCountry":"DENMARK","foreign_port":"K?BENHAVN","customer":"NIL-MASKED","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"47437.6","totalValueFC":"590021.8","currency":"USD","unitRateINR":"4110046.5","date":"03-Jul-2024","totalValueINR":"49320558","totalValueInUsd":"590021.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4311604","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"K?BENHAVN","supplierAddress":"N\/A","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722191400,"product":"AMPHOTERICIN B USP","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"NORTH CHINA PHARAMCEUTICAL HUASHENG","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"26500","totalValueFC":"6436.4","currency":"USD","unitRateINR":"2690128.7","date":"29-Jul-2024","totalValueINR":"538025.74","totalValueInUsd":"6436.4","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"4755110","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"CO. LTD. NO.8 YANGZI ROAD, ECONOMIC& TECHNOLOGICAL DEVELOPMENT ZONE,SHIJIAZHUANG, HEBEI, P.R.CHINA CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723487400,"product":"HIAB-AMPB-C018-N - AMPHOTERICIN B - LOT # HAN2403204LU","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"VIATRIS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"36","totalValueFC":"2521.5","currency":"USD","unitRateINR":"21150","date":"13-Aug-2024","totalValueINR":"211500","totalValueInUsd":"2521.5","indian_port":"Bangalore Air","hs_no":"29413090","bill_no":"5036406","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"1764 LITCHFIELD TURNPIKE SUITE 202WOODBRIDGE, CT, 06525 USASDNF United States","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726079400,"product":"AMPHOTERICIN B USP NST 1 KA","address":"SPARC, TANDALJA,,VADODARA, GUJARAT","city":"VADODARA,GUJARAT","supplier":"M\/S XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGA","unitRateFc":"45000","totalValueFC":"2056794","currency":"USD","unitRateINR":"3830263.5","date":"12-Sep-2024","totalValueINR":"172361857.5","totalValueInUsd":"2056794","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"5568768","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"DALSLANDSGADE 11 DK-2300 COPENHAGEN S DENAMRK DK","customerAddress":"SPARC, TANDALJA,,VADODARA, GUJARAT"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Drugs in Development

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FDA Orange Book

01

ABBOTT

U.S.A

BIO Partnering at JPM

Not Confirmed

02

ABRAXIS PHARM

U.S.A

BIO Partnering at JPM

Not Confirmed

03

ALKOPHARMA USA

U.S.A

BIO Partnering at JPM

Not Confirmed

04

EUGIA PHARMA

India

BIO Partnering at JPM

Not Confirmed

05

APOTHECON

U.S.A

BIO Partnering at JPM

Not Confirmed

06

APOTHECON

U.S.A

BIO Partnering at JPM

Not Confirmed

07

BRISTOL MYERS SQUIBB

U.S.A

BIO Partnering at JPM

Not Confirmed

08

LEADIANT BIOSCI INC

U.S.A

BIO Partnering at JPM

Not Confirmed

09

SPIL

Taiwan

BIO Partnering at JPM

Not Confirmed

10

TEVA PARENTERAL

Israel

BIO Partnering at JPM

Not Confirmed

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APIs

Amphotericin (100 g) API needed in India [ENA20423]

A company that focuses on manufacturing of various injectables, tablets, capsules, syrups, eye drops & ointments is looking for suppliers of Amphotericin (100 g) API for development purposes. The suppliers must support this enquiry with CoA.

Reply

02 Sep 2024

Amphotericin B API needed in the United States [ENA14438]

A drug development company that focuses in commercializing the dry powder nebulizer inhalation is looking for suppliers of Amphotericin B API for development purpose. The initial required quantity is 1 kg - 3 kg. The suppliers must support this enquiry with an active USDMF & GMP.

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23 Jul 2022

Injectable Grade Amphotericin B API needed in Iran [ENA13958]

A company that deals distribution of various pharmaceutical products is looking for suppliers of Injectable Grade Amphotericin B API for commercial purpose. The suppliers must support this enquiry with CEP & DMF.

Reply

13 Jun 2022

Amphotericin (1 MT - 2 MT/ annum) API needed in France [ENA13936]

A global pharmaceutical company that focuses in research, development & manufacturing of a wide range of products in various therapeutic segments like pain, CNS, cardiovascular, diabetes and gastroenterology is looking for suppliers of Amphotericin (1 MT - 2 MT/ annum) API for commercial purpose. The suppliers must support this enquiry with EUDMF or CEP. The final market is Europe.

Reply

11 Jun 2022

Amphotericin B (4 MT) API needed in Algeria [ENA12765]

A company that specializes in the development & manufacturing of various pharmaceutical products is looking for suppliers of Amphotericin B (4 MT) API for commercial purpose. The suppliers must support this enquiry with DMF, Dossier & GMP.

Reply

21 Feb 2022

Amphotericin (2.5 kg) API needed in India [ENA12212]

A company based in India that deals in the distribution of various pharmaceutical products is looking for suppliers of Amphotericin (2.5 kg) API for commercial purpose.

Reply

23 Dec 2021

USP Grade Amphotericin B API needed in Iran [ENA12181]

An institute that deals in the research & development of various pharmaceutical products is looking for suppliers of USP Grade Amphotericin B for injectable formulation. The required quantity is 1 kg for development & 30 kg/ annum for commercial purpose.

Reply

21 Dec 2021

EP/USP Grade Amphotericin B (50 g - 100 g) API needed in Switzerland [ENA11920]

One of the world's leading providers and manufacturers of healthcare solutions is looking for suppliers of EP/USP Grade Amphotericin B (50 g - 100 g) API for research purpose.

Reply

22 Nov 2021

Amphotericin B API needed in Italy [ENA11696]

One of the leading European pharmaceutical company that deals in the manufacturing of medical devices for ophthalmic surgery and human tissue banking is looking for suppliers of Amphotericin B API for development purpose. The suppliers must support this enquiry with CEP.

Reply

20 Oct 2021

Liposomal Amphotericin B API needed in Iran [ENA10996]

A company that deals in the R&D and commercialization of a wide range of pharmaceutical products is looking for suppliers of Liposomal Amphotericin B API for development purpose.

Reply

30 Jul 2021

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ABOUT THIS PAGE

Amphotericin B Manufacturers

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

Amphotericin B Suppliers

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

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

Amphotericin B USDMF

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

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

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Amphotericin B 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 Amphotericin B Drug Master File in Japan (Amphotericin B JDMF) empowers Amphotericin B 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 Amphotericin B JDMF during the approval evaluation for pharmaceutical products. At the time of Amphotericin B JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Amphotericin B KDMF

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

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

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

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Amphotericin B CEP

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

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

Amphotericin B WC

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

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

Amphotericin B 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 Amphotericin B as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Amphotericin B GMP

Amphotericin B 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 Amphotericin B 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 Amphotericin B GMP manufacturer or Amphotericin B GMP API supplier for your needs.

Amphotericin B CoA

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

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

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