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    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 Weight 924.1 g/mol
    Molecular Formula C47H73NO17
    XLogP30
    Hydrogen Bond Donor Count12
    Hydrogen Bond Acceptor Count18
    Rotatable Bond Count3
    Exact Mass923.48784986 g/mol
    Monoisotopic Mass923.48784986 g/mol
    Topological Polar Surface Area320 Ų
    Heavy Atom Count65
    Formal Charge0
    Complexity1670
    Isotope Atom Count0
    Defined Atom Stereocenter Count19
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count7
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameAbelcet
    PubMed HealthAmphotericin B Lipid Complex (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Active IngredientAmphotericin b
    Dosage FormInjectable, lipid complex
    RouteInjection
    Strength5mg/ml
    Market StatusPrescription
    CompanySigma Tau

    2 of 8  
    Drug NameAmbisome
    PubMed HealthAmphotericin B Liposome (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Active IngredientAmphotericin b
    Dosage FormInjectable, liposomal
    RouteInjection
    Strength50mg/vial
    Market StatusPrescription
    CompanyAstellas

    3 of 8  
    Drug NameAmphotec
    PubMed HealthAmphotericin B Cholesteryl Sulfate Complex (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Drug LabelAMPHOTEC 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 IngredientAmphotericin b
    Dosage FormInjectable, lipid complex
    RouteInjection
    Strength100mg/vial; 50mg/vial
    Market StatusPrescription
    CompanyAlkopharma Usa

    4 of 8  
    Drug NameAmphotericin b
    PubMed HealthAmphotericin B (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Drug LabelAmphotericin 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 IngredientAmphotericin b
    Dosage FormInjectable
    RouteInjection
    Strength50mg/vial
    Market StatusPrescription
    CompanyX Gen Pharms

    5 of 8  
    Drug NameAbelcet
    PubMed HealthAmphotericin B Lipid Complex (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Active IngredientAmphotericin b
    Dosage FormInjectable, lipid complex
    RouteInjection
    Strength5mg/ml
    Market StatusPrescription
    CompanySigma Tau

    6 of 8  
    Drug NameAmbisome
    PubMed HealthAmphotericin B Liposome (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Active IngredientAmphotericin b
    Dosage FormInjectable, liposomal
    RouteInjection
    Strength50mg/vial
    Market StatusPrescription
    CompanyAstellas

    7 of 8  
    Drug NameAmphotec
    PubMed HealthAmphotericin B Cholesteryl Sulfate Complex (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Drug LabelAMPHOTEC 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 IngredientAmphotericin b
    Dosage FormInjectable, lipid complex
    RouteInjection
    Strength100mg/vial; 50mg/vial
    Market StatusPrescription
    CompanyAlkopharma Usa

    8 of 8  
    Drug NameAmphotericin b
    PubMed HealthAmphotericin B (Injection)
    Drug ClassesAntifungal, Antiprotozoal
    Drug LabelAmphotericin 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 IngredientAmphotericin b
    Dosage FormInjectable
    RouteInjection
    Strength50mg/vial
    Market StatusPrescription
    CompanyX 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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      About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...

      ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships for product development, compliance, and secure logistics. ChemWerth accesses over 500 APIs and 30 manufacturing facilities across the US, Europe, India, and China, acts as a regulatory agent for 25+ FDA-approved facilities, sells 100+ products, and operates in 38 countries. In 2020, it filed its 500th DMF with the FDA . Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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      02

      LGM Pharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
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      Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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      Amphotericin

      About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

      LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
      LGM Pharma CB

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      03

      Century Pharmaceuticals

      India
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      Asia Pharma Expo
      Booth #2309
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      Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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      Amphotericin

      About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...

      Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with cGMP, 21 CFR, and ICH guidelines, and it also produces intermediates and develops new APIs as per client requirements. The company conducts biotechnological research on human therapeutic proteins, including treatments for asthma, mastocytosis, and basophilic leukemia, and supplies research-grade biotech and animal health products. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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      04

      Shanghai Minbiotech

      China
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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      Amphotericin B

      About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...

      Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
      Shanghai Minbiotech CB

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      05

      Beijing Mesochem Technology

      China
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      BIO Partnering at JPM
      Not Confirmed
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      Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

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      Amphotericin B

      About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...

      Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, and basic chemical materials. The company has an experienced R&D team and provides customized development, process optimization, contract manufacturing, and outsourcing services. Beijing Mesochem operates a production base in Weinan, Shanxi Province, featuring a 20,000 ㎡ facility with an annual capacity exceeding 8,000 MT. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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      06

      Sumar Biotech

      India
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      BIO Partnering at JPM
      Not Confirmed
      • fda
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      Virtual BoothSumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.

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      Amphotericin B

      About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufac...

      Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufacturing professionals, the company focuses on innovating and manufacturing semi-synthetic, synthetic, and fermentation-based APIs. Its R&D facility is equipped with advanced technology for synthesis, extraction, isolation, purification, and upstream fermentation, with active work in process chemistry for therapeutic molecules. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
      Sumar Biotech

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      07

      Willow Birch Pharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

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      Amphotericin B

      About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

      Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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      08

      Concord Biotech

      India
      BIO Partnering at JPM
      Not Confirmed
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      Concord Biotech

      India
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Amphotericin B

      About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-s...

      Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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      09

      RusBioPharm

      Russia
      BIO Partnering at JPM
      Not Confirmed
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      RusBioPharm

      Russia
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Amphotericin

      About the Company : RB Pharm is a leading pharmaceutical company specializing in the development, production, and distribution of high-quality generic and innovative medicines. With a strong focus on ...

      RB Pharm is a leading pharmaceutical company specializing in the development, production, and distribution of high-quality generic and innovative medicines. With a strong focus on research and development, we aim to enhance global healthcare by delivering affordable and effective solutions. Our portfolio includes a wide range of products across various therapeutic areas, ensuring the well-being of patients worldwide. At RB Pharm, we are committed to excellence, sustainability, and improving lives through advanced pharmaceutical innovations.
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      10

      Xellia Pharmaceuticals ApS

      Denmark
      BIO Partnering at JPM
      Not Confirmed
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      Xellia Pharmaceuticals ApS

      Denmark
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Amphotericin B

      About the Company : Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing clinically effective anti-infective treatments against serious and often life-threatening infectio...

      Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing clinically effective anti-infective treatments against serious and often life-threatening infections. With over 100 years of pharmaceutical industry expertise, we are a leading developer, manufacturer and trusted supplier of fermented and semi-synthetic Active Pharmaceutical Ingredients (APIs) and finished dosage forms (FDF), and the world-leading supplier of Vancomycin and Colistimethate Sodium (CMS). Our range of anti-infective treatments combat, most types of bacterial and antibiotic-resistant infections and certain fungal diseases.
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      API Reference Price

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L","customerCountry":"ARGENTINA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"15.5","totalValueFC":"1538.2","currency":"USD","unitRateINR":1200,"date":"20-Jun-2022","totalValueINR":"120000","totalValueInUsd":"1538.2","indian_port":"AHMEDABAD AIR","hs_no":"29419090","bill_no":"2241875","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"SARABHAI CAMMPUS,DR.V.S.MARG,,WADI WADI VADODARA, BARODA GUJARAT,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655663400,"product":"AMPHOTERICIN B USP 1 1(INTENDED FOR USE","address":"SARABHAI CAMMPUS,DR.V.S.MARG,,WADI WADI VADODARA","city":"BARODA GUJARAT,GUJARAT","supplier":"ASENCE PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"CORDOBA","customer":"QUIMICA LUAR S R 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LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"ASENCE PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"550","totalValueFC":"277277.3","currency":"USD","unitRateINR":"48950","date":"05-Sep-2025","totalValueINR":"24475000","totalValueInUsd":"277277.3","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"4317347","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ROOM B 16\/F EUBANK PLAZA 9 CHIU LUNG STREET, CENTRAL HONG KONG , HONG KONG","customerAddress":"SARABHAI CAMMPUS,DR.V.S.MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758565800,"product":"AMPHOTERICIN B USP NST AMPHOTERICIN B USP","address":"ADDITIONAL MIDC, PLOT NO K-27","city":"AMBERNATH","supplier":"XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"BHARAT SERUMS AND VACCINES LTD","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"44020","totalValueFC":"132929.2","currency":"USD","unitRateINR":"3911177","date":"23-Sep-2025","totalValueINR":"11733531","totalValueInUsd":"132929.2","indian_port":"Madras Air","hs_no":"29419090","bill_no":"4673595","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"DALSANDSGADA 11 KOEBENHAVN S 2300 DK SDNF DK","customerAddress":"ADDITIONAL MIDC, PLOT NO K-27"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1762885800,"product":"AMPHOTERICIN B USP NST 1 KA [BATCH:A2960286] [9 NOS] [QTY :8.288 KGS)AMPHOTERICIN B USP NST 1 KA [BATCH:A2960286] [9 NOS] [QTY :8","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"XELLIA PHARMACEUTICALS APS","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"EMCURE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"8.29","actualQuantity":"8.288","unit":"KGS","unitRateFc":"48865.8","totalValueFC":"407820.6","currency":"USD","unitRateINR":"4373491.8","date":"12-Nov-2025","totalValueINR":"36247500","totalValueInUsd":"407820.6","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3e68","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"DALSLANDSGADE 11, DK 2300 COPENHAGE N S DENMARK Copenhagen, , Denmark SDNF Denmark","customerAddress":"T-184, MIDC, BHOSARI,"}]
      20-Jan-2022
      26-Nov-2025
      KGS
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      Drugs in Development

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      • Development Update
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      Human Bioequivalence Study of Liposomal Amphotericin B for Injection

      Details:

      Amphotericin B is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Invasive Fungal Infections.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: UndisclosedProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable May 21, 2025

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      01

      Sichuan Huiyu Pharmaceutical

      China
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Sichuan Huiyu Pharmaceutical

      China
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      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Undisclosed

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Human Bioequivalence Study of Liposomal Amphotericin B for Injection

      Details : Amphotericin B is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Invasive Fungal Infections.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      May 21, 2025

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      Human Bioequivalence Study of Amphotericin B Liposome for Injection

      Details:

      Amphotericin B is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Invasive Fungal Infections.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: UndisclosedProduct Type: Miscellaneous

      Sponsor: Changsha King-eagle Med Technology

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable May 18, 2025

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      02

      Sichuan Huiyu Pharmaceutical

      China
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      BIO Partnering at JPM
      Not Confirmed

      Sichuan Huiyu Pharmaceutical

      China
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      BIO Partnering at JPM
      Not Confirmed
      • fda
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      • WHO-GMP
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Undisclosed

      Partner/Sponsor/Collaborator : Changsha King-eagle Med Technology

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Human Bioequivalence Study of Amphotericin B Liposome for Injection

      Details : Amphotericin B is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Invasive Fungal Infections.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      May 18, 2025

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      Matinas BioPharma Acquires Preferred Stock, Appoints Dr. Robin L. Smith

      Details:

      The funds will be used the Company’s antifungal drug candidate MAT2203 (Amphotericin B) for the treatment of invasive fungal infections.


      Lead Product(s): Amphotericin B,Fluocytosine

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: Phase IIIProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: $3.3 million Upfront Cash: Undisclosed

      Deal Type: Private Placement February 13, 2025

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      03

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
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      Lead Product(s) : Amphotericin B,Fluocytosine

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Phase III

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : $3.3 million

      Deal Type : Private Placement

      DEALS_DEV arrow-down

      Matinas BioPharma Acquires Preferred Stock, Appoints Dr. Robin L. Smith

      Details : The funds will be used the Company’s antifungal drug candidate MAT2203 (Amphotericin B) for the treatment of invasive fungal infections.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Undisclosed

      February 13, 2025

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      Matinas Bio Reports Successful Treatment of Limb-Threatening Mucor Infection with MAT2203

      Details:

      MAT2203 (Amphotericin B) is a potential oral broad-spectrum treatment for invasive deadly fungal infections, which is being evaluated in patients with Limb-threatening mucor infection.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: PreclinicalProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable June 24, 2024

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      04

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Preclinical

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Matinas Bio Reports Successful Treatment of Limb-Threatening Mucor Infection with MAT2203

      Details : MAT2203 (Amphotericin B) is a potential oral broad-spectrum treatment for invasive deadly fungal infections, which is being evaluated in patients with Limb-threatening mucor infection.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      June 24, 2024

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      Three Patients in Matinas BioPharma's Program Achieve Complete Response to Infection

      Details:

      MAT2203 (amphotericin B) is an orally administered lipid nanocrystal (LNC) formulation of amphotericin B, which is being evaluated for the treatment of invasive fusarium infection.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: Phase IProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable March 22, 2024

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      05

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
      • fda
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      • WHO-GMP
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Phase I

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Three Patients in Matinas BioPharma's Program Achieve Complete Response to Infection

      Details : MAT2203 (amphotericin B) is an orally administered lipid nanocrystal (LNC) formulation of amphotericin B, which is being evaluated for the treatment of invasive fusarium infection.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      March 22, 2024

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      Matinas BioPharma Updates Outcomes on MAT2203 Compassionate Use Program

      Details:

      MAT2203 (amphotericin B), an oral formulation using LNC technology, is in preclinical studies for invasive aspergillosis with limited treatment options.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: IND EnablingProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable February 26, 2024

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      06

      Matinas BioPharma

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
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      BIO Partnering at JPM
      Not Confirmed
      • fda
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      • WHO-GMP
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : IND Enabling

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Matinas BioPharma Updates Outcomes on MAT2203 Compassionate Use Program

      Details : MAT2203 (amphotericin B), an oral formulation using LNC technology, is in preclinical studies for invasive aspergillosis with limited treatment options.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      February 26, 2024

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      Matinas Reaches Agreement with FDA for Phase 3 to Support NDA for MAT2203 in Aspergillosis

      Details:

      MAT2203 (amphotericin B) acts by binding to the sterol component of a cell membrane leading to alterations in cell permeability & cell death. It is being evaluated for invasive aspergillosis.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: IND EnablingProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable February 20, 2024

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      07

      Matinas BioPharma

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : IND Enabling

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Matinas Reaches Agreement with FDA for Phase 3 to Support NDA for MAT2203 in Aspergillosis

      Details : MAT2203 (amphotericin B) acts by binding to the sterol component of a cell membrane leading to alterations in cell permeability & cell death. It is being evaluated for invasive aspergillosis.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      February 20, 2024

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      Cipla Partners with CSIR-CDRI to Develop Formulation for Fungal Keratitis

      Details:

      The partnership allows Cipla to scale up amphotericin, conducting studies and seeking regulatory approvals for commercialization in treating fungal keratitis.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: PreclinicalProduct Type: Miscellaneous

      Sponsor: Cipla

      Deal Size: Undisclosed Upfront Cash: Undisclosed

      Deal Type: Partnership February 15, 2024

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      08

      Central Drug Research Institute

      Country
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Central Drug Research Institute

      Country
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      BIO Partnering at JPM
      Not Confirmed
      • fda
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Preclinical

      Partner/Sponsor/Collaborator : Cipla

      Deal Size : Undisclosed

      Deal Type : Partnership

      DEALS_DEV arrow-down

      Cipla Partners with CSIR-CDRI to Develop Formulation for Fungal Keratitis

      Details : The partnership allows Cipla to scale up amphotericin, conducting studies and seeking regulatory approvals for commercialization in treating fungal keratitis.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Undisclosed

      February 15, 2024

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      Matinas BioPharma Provides Update to MAT2203 Regulatory and Development Pathway Following Feedback from FDA

      Details:

      MAT2203 (amphotericin B) is an oral formulation based on the LNC platform delivery technology. It is being evaluated in preclinical studies for the treatment of invasive aspergillosis with limited or no treatment options.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

      Study Phase: PreclinicalProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable December 21, 2023

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      09

      Matinas BioPharma

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Matinas BioPharma

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Infections and Infectious Diseases

      Highest Development Status : Preclinical

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Matinas BioPharma Provides Update to MAT2203 Regulatory and Development Pathway Following Feedback...

      Details : MAT2203 (amphotericin B) is an oral formulation based on the LNC platform delivery technology. It is being evaluated in preclinical studies for the treatment of invasive aspergillosis with limited or no treatment options.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      December 21, 2023

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      Patient with Candida krusei Infection in Matinas BioPharma's Oral MAT2203 Expanded Access Program Achieves Complete Clinical Resolution

      Details:

      MAT2203 is a potential oral formulation broad-spectrum treatment for invasive deadly fungal infections. Although amphotericin B is a fungicidal agent, it is currently only available through an intravenous, while MAT2203 has oral route of administration.


      Lead Product(s): Amphotericin B,Inapplicable

      Therapeutic Area: Urology Brand Name: Undisclosed

      Study Phase: PreclinicalProduct Type: Miscellaneous

      Sponsor: Undisclosed

      Deal Size: Inapplicable Upfront Cash: Inapplicable

      Deal Type: Inapplicable October 11, 2023

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      10

      Matinas BioPharma

      U.S.A
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      Lead Product(s) : Amphotericin B,Inapplicable

      Therapeutic Area : Urology

      Highest Development Status : Preclinical

      Partner/Sponsor/Collaborator : Undisclosed

      Deal Size : Inapplicable

      Deal Type : Inapplicable

      DEALS_DEV arrow-down

      Patient with Candida krusei Infection in Matinas BioPharma's Oral MAT2203 Expanded Access Program ...

      Details : MAT2203 is a potential oral formulation broad-spectrum treatment for invasive deadly fungal infections. Although amphotericin B is a fungicidal agent, it is currently only available through an intravenous, while MAT2203 has oral route of administration.

      Product Name : Undisclosed

      Product Type : Miscellaneous

      Upfront Cash : Inapplicable

      October 11, 2023

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      Europe

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      01

      Abacus Medicine A/S

      Denmark
      BIO Partnering at JPM
      Not Confirmed
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      Denmark
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      Regulatory Info : Deregistered

      Registration Country : Sweden

      Amphotericin B

      Brand Name : Ambisome Liposomal

      Dosage Form : Solution For Injection

      Dosage Strength : 50mg

      Packaging :

      Approval Date : 07/11/2018

      Application Number : 20180119000086

      Regulatory Info : Deregistered

      Registration Country : Sweden

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      02

      BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

      Portugal
      BIO Partnering at JPM
      Not Confirmed
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      BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

      Portugal
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      Regulatory Info :

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      Amphotericin B

      Brand Name :

      Dosage Form : Liposome Injection

      Dosage Strength : 50MG

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      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Portugal

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      Bristol-Myers Squibb Ab

      U.S.A
      BIO Partnering at JPM
      Not Confirmed
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      U.S.A
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      Regulatory Info : Deregistered

      Registration Country : Sweden

      Amphotericin B

      Brand Name : Fungizone

      Dosage Form : Lozenge

      Dosage Strength : 10mg

      Packaging :

      Approval Date : 16/06/1972

      Application Number : 19720616000017

      Regulatory Info : Deregistered

      Registration Country : Sweden

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      Cheplapharm Arzneimittel Gmbh

      Germany
      BIO Partnering at JPM
      Not Confirmed
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      Cheplapharm Arzneimittel Gmbh

      Germany
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      Regulatory Info : Approved

      Registration Country : Sweden

      Amphotericin B

      Brand Name : Fungizone

      Dosage Form : Solution For Injection

      Dosage Strength : 50mg

      Packaging :

      Approval Date : 24/11/1959

      Application Number : 19591124000017

      Regulatory Info : Approved

      Registration Country : Sweden

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      05

      Dermapharm Ag

      Germany
      BIO Partnering at JPM
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      Dermapharm Ag

      Germany
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      Regulatory Info : Allowed

      Registration Country : Switzerland

      Amphotericin B

      Brand Name : Ampho-Moronal

      Dosage Form : Tablet

      Dosage Strength : 100mg

      Packaging :

      Approval Date : 07/05/1974

      Application Number : 37245

      Regulatory Info : Allowed

      Registration Country : Switzerland

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      06

      Gilead Sciences Switzerland S?rl

      U.S.A
      BIO Partnering at JPM
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      U.S.A
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      Regulatory Info : Allowed

      Registration Country : Switzerland

      Amphotericin B

      Brand Name : AmBisome

      Dosage Form : Dispersion For Infusion

      Dosage Strength : 50mg

      Packaging :

      Approval Date : 19/12/1996

      Application Number : 53342

      Regulatory Info : Allowed

      Registration Country : Switzerland

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      07

      Orifarm Ab

      Denmark
      BIO Partnering at JPM
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      Denmark
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      Regulatory Info : Deregistered

      Registration Country : Sweden

      Amphotericin B

      Brand Name : Ambisome

      Dosage Form : Solution For Injection

      Dosage Strength : 50mg

      Packaging :

      Approval Date : 18/06/2014

      Application Number : 20120810000015

      Regulatory Info : Deregistered

      Registration Country : Sweden

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      TEVA ITALIA Srl

      Israel
      BIO Partnering at JPM
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      Israel
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      Regulatory Info :

      Registration Country : Italy

      Amphotericin B

      Brand Name : Abelcet

      Dosage Form : Amphotericin B 100Mg 20Ml 1 Units Parenteral Use

      Dosage Strength : 10 VIALS EV 100 mg 20 ml + 10 needles

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Italy

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      09

      Tillomed Malta Limited

      Country
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      Regulatory Info : Approved

      Registration Country : Sweden

      Amphotericin B

      Brand Name : Amphotericin B Liposomal Tillomed

      Dosage Form : Infusion Solution

      Dosage Strength : 50mg

      Packaging :

      Approval Date : 19/05/2025

      Application Number : 20230525000016

      Regulatory Info : Approved

      Registration Country : Sweden

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      Central Procurement & Supplies Unit

      Country
      BIO Partnering at JPM
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      Regulatory Info : Authorised

      Registration Country : Malta

      Amphotericin B

      Brand Name : Fungizone

      Dosage Form : Powder For Solution For Infusion

      Dosage Strength : 50MG

      Packaging :

      Approval Date : 2025-01-24

      Application Number :

      Regulatory Info : Authorised

      Registration Country : Malta

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      Aspen Pharmacare Australia Pty Limited

      South Africa
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      Amphotericin B

      Brand Name : Fungilin

      Dosage Form :

      Dosage Strength : 10 mg

      Packaging : 20

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Australia

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      Aspen Pharmacare Australia Pty Limited

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      Amphotericin B

      Brand Name : Fungilin

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      01

      Brand Name : AmBisome

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      Gilead

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2020 Revenue in Millions : 436

      2019 Revenue in Millions : 407

      Growth (%) : 7

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      Astellas

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2020 Revenue in Millions : 112

      2019 Revenue in Millions : 110

      Growth (%) : 2

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      Dainippon Sumitomo

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2020 Revenue in Millions : 36

      2019 Revenue in Millions : 40

      Growth (%) : -12

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      Astellas

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      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2021 Revenue in Millions : 139

      2020 Revenue in Millions : 111

      Growth (%) : 35

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      Brand Name : AmBisome

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      Gilead

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2021 Revenue in Millions : 540

      2020 Revenue in Millions : 436

      Growth (%) : 24

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      Brand Name : Ambisome

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      Astellas

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      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2022 Revenue in Millions : 115

      2021 Revenue in Millions : 138

      Growth (%) : -17

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      Gilead

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2022 Revenue in Millions : 497

      2021 Revenue in Millions : 540

      Growth (%) : -8

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      Brand Name : AmBisome

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      Gilead

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2023 Revenue in Millions : 492

      2022 Revenue in Millions : 497

      Growth (%) : -1

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      Gilead

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases

      Currency : USD

      2024 Revenue in Millions : 533

      2023 Revenue in Millions : 492

      Growth (%) : 8

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      Astellas

      Amphotericin B

      Main Therapeutic Indication : Infectious Diseases (HIV, Hepatitis...

      Currency : USD

      2018 Revenue in Millions : 115

      2017 Revenue in Millions : 97

      Growth (%) : 18%

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      india-flag.png
      Amphotericin B API needed in India [ENA24904]
      A company that focuses on the development and manufacturing of various finished formulations majorly in oncology and antiretrovirals areas is looking for suppliers of Amphotericin B API for development purposes. The suppliers must support this enquiry with CoA.
      24 Dec 2025

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      24 Dec 2025

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      Reply Comment (1)

      24 Dec 2025

      india-flag.png
      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.
      02 Sep 2024

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      02 Sep 2024

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      02 Sep 2024

      United_States_of_America.png
      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.
      23 Jul 2022

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      23 Jul 2022

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      Reply Comment (7)

      23 Jul 2022

      Iran.png
      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.
      13 Jun 2022

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      13 Jun 2022

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      Reply Comment (9)

      13 Jun 2022

      France.png
      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.
      11 Jun 2022

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      11 Jun 2022

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      11 Jun 2022

      Algeria.png
      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.
      21 Feb 2022

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      21 Feb 2022

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      21 Feb 2022

      india-flag.png
      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.
      23 Dec 2021

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      23 Dec 2021

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      Reply Comment (3)

      23 Dec 2021

      Iran.png
      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.
      21 Dec 2021

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      21 Dec 2021

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      Reply Comment (8)

      21 Dec 2021

      Switzerland.png
      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.
      22 Nov 2021

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      22 Nov 2021

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      22 Nov 2021

      Italy.png
      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.
      20 Oct 2021

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      20 Oct 2021

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      20 Oct 2021

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      FDF DOSSIERS

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      Amphotericin (50 mg) Vial needed in Saudi Arabia [ENA19155]
      A company that focuses on distribution of various finished formulations in hospitals is looking for Amphotericin (50 mg) Vial for commercial purposes. The required quantity is a 230 units. The supplier must support this enquiry with GMP, ECTD & Stability Zone IV.
      07 Mar 2024

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      07 Mar 2024

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      07 Mar 2024

      Yemen.png
      Liposomal Amphotericin B (50 mg) Injections needed in Yemen [ENA18523]
      A company that deals in the distribution of various finished formulations is looking for suppliers of Liposomal Amphotericin B (50 mg) Injections for commercial purposes. The required quantity is 1 lakh unit/ annum.
      02 Nov 2023

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      02 Nov 2023

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      02 Nov 2023

      Yemen.png
      Liposomal Amphotericin B (50 mg) Injections needed in Yemen [ENA18083]
      A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Various Liposomal Amphotericin B (50 mg) Injections for commercial purposes. The required quantity is 10,000 units.
      18 Sep 2023

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      18 Sep 2023

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      18 Sep 2023

      Brazil.png
      Liposomal Amphotericin-B (50 mg) Injections needed in Brazil [ENA17228]
      A company that deals in the research, development & trading of health products is looking for suppliers for In-licensing with supply of Liposomal Amphotericin-B (50 mg) Injections for commercial purposes. The required quantity is 150 million units. The suppliers must support this enquiry with CTD Dossier.
      03 Jun 2023

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      03 Jun 2023

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      03 Jun 2023

      Jordan.png
      Various Finished Dosage Formulations needed in Jordan [ENA11468]
      A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The suppliers must support this enquiry with EU dossiers for each. 1. Infliximab (100 mg) Vials. The required quantity is 98,500 units. 2. Liposomal Amphotericin (50 mg) Vials. The required quantity is 23,000 units. 3. Voriconazole (200 mg) Vials. The required quantity is 17,800 units. 4. Omeprazole (40 mg) Vials. The required quantity is 700,000 units. 5. Meropenem (1 g & 500 mg) Vials. The required quantity is 800,000 units & 550,000 units respectively. 6. Vancomycin (1 g) Vials. The required quantity is 500,000 units.
      22 Sep 2021

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      22 Sep 2021

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      Reply Comment (11)

      22 Sep 2021

      turkeypng-1602828403png-1622460951png-1622462103.png
      Liposomal Amphotericin B (50 mg/ 10 ml) Vials needed in Turkey [ENA11033]
      Istanbul Pharma, a company that deals in the export of various pharmaceutical products and medical devices is looking for suppliers of Liposomal Amphotericin B (50 mg/ 10 ml) Vials for commercial purpose. The required quantity is 1,000,000 units per month for two years. The final market is India. Interested suppliers can contact them via their email: sabet@istanbulpharma.com.
      05 Aug 2021

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      05 Aug 2021

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      Reply Comment (3)

      05 Aug 2021

      United_States_of_America.png
      Amphotericin B & Propofol Injections needed in the United States [ENA10711]
      A company that specializes in procuring and marketing pharmaceutical products, medical supplies, devices and equipment is looking for suppliers of Various Finished Dosage Formulations for commercial purposes. The final market is Latin America & Caribbean Nations. 1. BP Grade Propofol (1% w/w in 20 ml) Injections. The required quantity is 700,000 units. 2. Liposomal Amphotericin B (50 mg) Injections. The required quantity is 10,000,000 units.
      25 Jun 2021

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      25 Jun 2021

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      Reply Comment (13)

      25 Jun 2021

      United_States_of_America.png
      Liposomal Amphotericin B (50 mg) Injections needed in the United States [ENA10560]
      One of the leading distributors in the US is looking for suppliers of Liposomal Amphotericin B (50 mg) Injections. The required quantity is 10,000 units.
      03 Jun 2021

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      03 Jun 2021

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      Reply Comment (6)

      03 Jun 2021

      india-flag.png
      Amphotericin B (50 mg) Injections needed in India [ENA10474]
      Elyzium Group, a company that deals in medical equipment is looking for suppliers of Amphotericin B (50 mg) Injections. Interested suppliers can contact them via their email: kunal@eglobetrotting.com.
      22 May 2021

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      22 May 2021

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      Reply Comment (2)

      22 May 2021

      india-flag.png
      Amphotericin B (50 mg) Injections needed in India [ENA10434]
      A company based in Hong Kong that offers a wide range of high-quality medical products is looking for suppliers of Liposomal Amphotericin B (50 mg) Injections for commercial purposes. The required quantity is 4,000 units.
      18 May 2021

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      18 May 2021

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      Reply Comment (5)

      18 May 2021

      Only 10 entries up to this point, click to access all click full view read-more
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      Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

      Patents & EXCLUSIVITIES

      Check the patents & exclusivity for this product

      Health Canada Patents

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      01

      Astellas Pharma Canada Inc.

      Liposomal Amphotericin B
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      BIO Partnering at JPM
      Not Confirmed

      Astellas Pharma Canada Inc.

      Japan
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Patent Expiration Date : 2014-03-25

      Date Granted : 1997-03-25

      Liposomal Amphotericin B

      Brand Name : AMBISOME

      Patent Number : 1339008

      Filing Date : 1988-11-10

      Strength per Unit : 50 mg amphotericin B per vial

      Dosage Form : Lyophilized powder for reconsititution

      Human Or VET : Human

      Route of Administration : Intravenous

      Patent Expiration Date : 2014-03-25

      Date Granted : 1997-03-25

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      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      02

      Sigma-Tau Pharmaceuticals Inc.

      Amphotericin B Lipid Complex
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Sigma-Tau Pharmaceuticals Inc.

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Patent Expiration Date : 2013-11-12

      Date Granted : 1996-11-12

      Amphotericin B Lipid Complex

      Brand Name : ABELCET

      Patent Number : 1338701

      Filing Date : 1988-02-29

      Strength per Unit : 5mg/ml

      Dosage Form : Intravenous Injection

      Human Or VET : Human

      Route of Administration : Intravenous Injection

      Patent Expiration Date : 2013-11-12

      Date Granted : 1996-11-12

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      Product Web Link

      Virtual Booth

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      03

      Sigma-Tau Pharmaceuticals Inc.

      Amphotericin B Lipid Complex
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Sigma-Tau Pharmaceuticals Inc.

      U.S.A
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Patent Expiration Date : 2013-11-26

      Date Granted : 1996-11-26

      Amphotericin B Lipid Complex

      Brand Name : ABELCET

      Patent Number : 1338736

      Filing Date : 1987-12-01

      Strength per Unit : 5mg/ml

      Dosage Form : Intravenous Injection

      Human Or VET : Human

      Route of Administration : Intravenous Injection

      Patent Expiration Date : 2013-11-26

      Date Granted : 1996-11-26

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      04

      CT Corporation System Canada...

      Amphotericin B
      arrow
      BIO Partnering at JPM
      Not Confirmed

      CT Corporation System Canada Ltd.

      Country
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Patent Expiration Date : 2012-09-05

      Date Granted : 1995-09-05

      Amphotericin B

      Brand Name : AMPHOTEC

      Patent Number : 1336890

      Filing Date : 1988-02-29

      Strength per Unit : 50mg VIAL

      Dosage Form : Powder for Reconstitution

      Human Or VET : Human

      Route of Administration : Intravenous

      Patent Expiration Date : 2012-09-05

      Date Granted : 1995-09-05

      blank

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      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      05

      CT Corporation System Canada...

      Amphotericin B
      arrow
      BIO Partnering at JPM
      Not Confirmed

      CT Corporation System Canada Ltd.

      Country
      arrow
      BIO Partnering at JPM
      Not Confirmed

      Patent Expiration Date : 2012-09-05

      Date Granted : 1995-09-05

      Amphotericin B

      Brand Name : AMPHOTEC

      Patent Number : 1336890

      Filing Date : 1988-02-29

      Strength per Unit : 100mg VIAL

      Dosage Form : Powder for Reconstitution

      Human Or VET : Human

      Route of Administration : Intravenous

      Patent Expiration Date : 2012-09-05

      Date Granted : 1995-09-05

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      Product Web Link

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      Website

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      REF. STANDARDS & IMPURITIES

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      ABOUT THIS PAGE

      Looking for 1397-89-3 / Amphotericin B API manufacturers, exporters & distributors?

      Amphotericin B manufacturers, exporters & distributors 1

      74

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

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

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

      API | Excipient name

      Amphotericin B

      Synonyms

      1397-89-3, Amphotericin, Amphotericine b, Fungizone, Ambisome, Ampho-moronal

      Cas Number

      1397-89-3

      Unique Ingredient Identifier (UNII)

      7XU7A7DROE

      About Amphotericin B

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

      AmBisome (TN) Manufacturers

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

      AmBisome (TN) Suppliers

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

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

      AmBisome (TN) USDMF

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

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

      click here to find a list of AmBisome (TN) suppliers with USDMF on PharmaCompass.

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

      AmBisome (TN) KDMF

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

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

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

      click here to find a list of AmBisome (TN) suppliers with KDMF on PharmaCompass.

      AmBisome (TN) CEP

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

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

      AmBisome (TN) WC

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

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

      AmBisome (TN) 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 AmBisome (TN) as an active pharmaceutical ingredient (API).

      Finished drug products

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

      click here to find a list of AmBisome (TN) suppliers with NDC on PharmaCompass.

      AmBisome (TN) GMP

      AmBisome (TN) 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 AmBisome (TN) 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 AmBisome (TN) GMP manufacturer or AmBisome (TN) GMP API supplier for your needs.

      AmBisome (TN) CoA

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

      AmBisome (TN) CoA mostly includes findings from lab analyses of a specific batch. For each AmBisome (TN) 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.

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