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    Chemistry

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    Also known as: 25316-40-9, Doxorubicin hcl, Rubex, Adriacin, Adriblastina, Caelyx
    Molecular Formula
    C27H30ClNO11
    Molecular Weight
    580.0  g/mol
    InChI Key
    MWWSFMDVAYGXBV-RUELKSSGSA-N
    FDA UNII
    82F2G7BL4E
    Doxorubicin Hydrochloride
    Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
    1 2D Structure

    Doxorubicin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (7S,9S)-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C27H29NO11.ClH/c1-10-22(31)13(28)6-17(38-10)39-15-8-27(36,16(30)9-29)7-12-19(15)26(35)21-20(24(12)33)23(32)11-4-3-5-14(37-2)18(11)25(21)34;/h3-5,10,13,15,17,22,29,31,33,35-36H,6-9,28H2,1-2H3;1H/t10-,13-,15-,17-,22+,27-;/m0./s1
    2.1.3 InChI Key
    MWWSFMDVAYGXBV-RUELKSSGSA-N
    2.1.4 Canonical SMILES
    CC1C(C(CC(O1)OC2CC(CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=O)CO)O)N)O.Cl
    2.1.5 Isomeric SMILES
    C[C@H]1[C@H]([C@H](C[C@@H](O1)O[C@H]2C[C@@](CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=O)CO)O)N)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    82F2G7BL4E
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Adriablastin

    2. Adriablastine

    3. Adriamycin

    4. Adriblastin

    5. Adriblastina

    6. Adriblastine

    7. Adrimedac

    8. Doxo Cell

    9. Doxo-cell

    10. Doxolem

    11. Doxorubicin

    12. Doxorubicin Hexal

    13. Doxorubicin Nc

    14. Doxorubicina Ferrer Farm

    15. Doxorubicina Funk

    16. Doxorubicina Tedec

    17. Doxorubicine Baxter

    18. Doxotec

    19. Farmiblastina

    20. Hydrochloride, Doxorubicin

    21. Myocet

    22. Onkodox

    23. Ribodoxo

    24. Rubex

    25. Urokit Doxo Cell

    26. Urokit Doxo-cell

    2.3.2 Depositor-Supplied Synonyms

    1. 25316-40-9

    2. Doxorubicin Hcl

    3. Rubex

    4. Adriacin

    5. Adriblastina

    6. Caelyx

    7. Doxil

    8. Adriamycin Hydrochloride

    9. Doxorubicin (adriamycin) Hcl

    10. Adriamycin, Hydrochloride

    11. Doxorubicin (hydrochloride)

    12. Hydroxydaunorubicin Hydrochloride

    13. Adriablastina Cs

    14. Adriblastin

    15. Nsc 123127

    16. Hydroxydaunomycin Hydrochloride

    17. Mls001401460

    18. 82f2g7bl4e

    19. Adm Hydrochloride

    20. Lipodox

    21. Smr000058570

    22. Adriamycin Pfs

    23. Adriamycin Rdf

    24. Dsstox_cid_10636

    25. Dsstox_rid_78854

    26. Dsstox_rid_80678

    27. Dsstox_gsid_30636

    28. Dsstox_gsid_45111

    29. (8s,10s)-10-(((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrochloride

    30. (8s,10s)-10-{[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy}-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-5,7,8,9,10,12-hexahydrotetracene-5,12-dione Hydrochloride

    31. Adrosal

    32. Duxocin

    33. Doxorubicin Citric Acid Salt

    34. Adriamycin Hydrochloride-dna Complex

    35. Mls000028393

    36. Mfcd00077757

    37. Lipo-dox

    38. Fi 6804

    39. (7s,9s)-7-[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione;hydrochloride

    40. (8s-cis)-10-[(3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione Hydrochloride

    41. Nsc-123127

    42. Sr-01000003049

    43. Kw-125

    44. Unii-82f2g7bl4e

    45. Resmycin

    46. Ccris 740

    47. Doxorubicin.hcl

    48. Doxorubicin Hydrochloride [jan]

    49. Doxorubicin, Hcl

    50. Adriamycin (tn)

    51. Adriacin (tn)

    52. (1s,3s)-3-glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-a-l-lyxo-hexopyranoside Hydrochloride

    53. (8s,10s)-10-((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrochloride

    54. (8s-cis)-10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione Hydrochloride

    55. Prestwick_188

    56. Einecs 246-818-3

    57. Doxorubicin Hydrochloride [usp:jan]

    58. Doxil (tn)

    59. Rubex (tn)

    60. Cpd000058570

    61. Adriblastina Hydrochloride

    62. (8s,10s)-10-(((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracen

    63. Dox

    64. Adriamycin [iarc]

    65. Doxorubicini Hydrochloridum

    66. Ncgc00163543-01

    67. Schembl3242

    68. Cas-25316-40-9

    69. Mls000049969

    70. Mls000049970

    71. Mls000049971

    72. Mls000070047

    73. Mls000392861

    74. Mls000392871

    75. Mls000392881

    76. Mls000392891

    77. Mls000392901

    78. Mls000759533

    79. Mls001055359

    80. Doxorubicin Hydrochloride,(s)

    81. Chembl359744

    82. Dtxsid3030636

    83. Chebi:31522

    84. Doxorubicin Hydrochloride- Bio-x

    85. Doxorubicin Hydrochloride Solution

    86. Liposomal Doxorubicin Hydrochloride

    87. Bcpp000429

    88. Hms1569g18

    89. Kuc110341c

    90. Ex-a1337

    91. Tox21_110050

    92. Tox21_112061

    93. Tox21_202483

    94. Adriamycin (doxorubicin Hydrochloride

    95. S1208

    96. Akos007930231

    97. Akos015920241

    98. Doxorubicin Hydrochloride (jp17/usp)

    99. Tox21_110050_1

    100. Bcp9000237

    101. Ccg-100975

    102. Cs-1239

    103. Nc00225

    104. 2-chloro-4-fluorobenzenesulphonylchloride

    105. Doxorubicin Hydrochloride [mart.]

    106. Doxorubicin Hydrochloride [vandf]

    107. Doxorubicin Hydrochloride Liposome

    108. Ncgc00014486-01

    109. Ncgc00024415-33

    110. Ncgc00024415-36

    111. Ncgc00260032-01

    112. Ncgc00263918-03

    113. (8s,10s)-10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione Hydrochloride

    114. As-31687

    115. Bd164391

    116. Doxorubicin Hydrochloride [usp-rs]

    117. Doxorubicin Hydrochloride [who-dd]

    118. Doxorubicin Hydrochloride [who-ip]

    119. Hy-15142

    120. Ksc-230-184-1

    121. Doxorubicin Hydrochloride [ema Epar]

    122. D01275

    123. Doxorubicin Hydrochloride [ep Monograph]

    124. Doxorubicin Hydrochloride [orange Book]

    125. Doxorubicin Hydrochloride [usp Monograph]

    126. 316d409

    127. A817779

    128. Doxorubicin Hydrochloride Liposome [vandf]

    129. Doxorubicin Liposomal Complex Of The Hydrochloride

    130. Doxorubicini Hydrochloridum [who-ip Latin]

    131. Doxorubicin Hydrochloride, 98.0-102.0% (hplc)

    132. Imx-110 Component Doxorubicin Hydrochloride

    133. Liposomal Doxorubicin Hydrochloride [who-dd]

    134. Sr-01000003049-5

    135. Q27032359

    136. Sr-01000003049-10

    137. Z1557399790

    138. Doxorubicin Liposomal Complex Of The Hydrochloride [mi]

    139. Doxorubicin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    140. Doxorubicin Hydrochloride, Suitable For Fluorescence, 98.0-102.0% (hplc)

    141. Doxorubicin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    142. Doxorubicin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    143. (8s,10s)-10-(((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dionehydrochloride

    144. (8s,10s)-10-((3-amino-2,3,6-trideoxy-.alpha.-l-lyxo-hexopyranosyl)oxy)-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione Hydrochloride

    145. 10-[(3-amino-2,3,6-trideoxy-?-l-lyxohexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-5,12-naphthacenedione Hydrochloride

    146. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-.alpha.-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, Hydrochloride (8s-cis)-

    147. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, Hydrochloride, (8s,10s)-

    148. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, Hydrochloride, (8s-cis)-

    149. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, Hydrochloride (8s-cis)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 580.0 g/mol
    Molecular Formula C27H30ClNO11
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count5
    Exact Mass579.1507385 g/mol
    Monoisotopic Mass579.1507385 g/mol
    Topological Polar Surface Area206 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity977
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameDoxorubicin hydrochloride
    PubMed HealthDoxorubicin Hydrochloride Liposome (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelDoxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Ch...
    Active IngredientDoxorubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength2mg/ml; 10mg/vial; 200mg/100ml; 50mg/vial; 20mg/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Pharmachemie Bv; Onco Therapies; Sun Pharm Inds; Teva Pharms Usa; Sagent Pharms; Eurohlth Intl; Alvogen; Sandoz; Actavis

    2 of 2  
    Drug NameDoxorubicin hydrochloride
    PubMed HealthDoxorubicin Hydrochloride Liposome (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelDoxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Ch...
    Active IngredientDoxorubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength2mg/ml; 10mg/vial; 200mg/100ml; 50mg/vial; 20mg/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Pharmachemie Bv; Onco Therapies; Sun Pharm Inds; Teva Pharms Usa; Sagent Pharms; Eurohlth Intl; Alvogen; Sandoz; Actavis

    4.2 Drug Indication

    Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

    Caelyx pegylated liposomal is indicated:

    - as monotherapy for patients with metastatic breast cancer , where there is an increased cardiac risk;

    - for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;

    - in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant;

    - for treatment of AIDS-related Kaposis sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.

    Caelyx pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standarddoxorubicin (or other anthracycline).

    Treatment of breast and ovarian cancer .

    Treatment of hepatocellular carcinoma

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Topoisomerase II Inhibitors

    Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)

    Antibiotics, Antineoplastic

    Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Anthracyclines [CS]; Topoisomerase Inhibitors [MoA]; Anthracycline Topoisomerase Inhibitor [EPC]
    5.3 ATC Code

    L01DB01

    L01DB

    L01DB01

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-10-18

    Pay. Date : 2015-12-28

    DMF Number : 13209

    Submission : 1998-04-30

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2003-151 - Rev 03

    Issue Date : 2020-04-02

    Type : Chemical

    Substance Number : 714

    Status : Valid

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    Registration Number : 302MF10073

    Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2020-07-01

    Latest Date of Registration : --

     EU-WC NDC arrow-down
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    NDC Package Code : 12543-3209

    Start Marketing Date : 2010-01-14

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10g/10g)

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
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    Registrant Name : Boxter Co., Ltd.

    Registration Date : 2021-02-17

    Registration Number : 20210217-210-J-674

    Manufacturer Name : Meiji Seika Pharma Co., Ltd. Kitakami Plant

    Manufacturer Address : 3-3, Kitakogyodanchi Kitakami-shi, Iwate-ken 024-0193, Japan

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    08

    Sterling Biotech

    India

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    BIO Partnering at JPM
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    Sterling Biotech

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24858

    Submission : 2011-04-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-039 - Rev 01

    Issue Date : 2020-01-02

    Type : Chemical

    Substance Number : 714

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2020-12-18

    Valid Till : 2023-12-17

    Written Confirmation Number : WC-0292

    Address of the Firm :

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    RPG Life Sciences

    India

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    RPG Life Sciences

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24128

    Submission : 2010-08-31

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2016-02-23

    Valid Till : 2019-02-23

    Written Confirmation Number : WC-0357

    Address of the Firm :

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    10

    Teva Pharmaceutical Industries

    Israel

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    Teva Pharmaceutical Industries

    Israel

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    API Reference Price

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    19-Jan-2021
    24-Dec-2024
    KGS
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    DOSAGE - INJECTABLE;INJECTION - 150MG/75ML

    USFDA APPLICATION NUMBER - 50629

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    DOSAGE - INJECTABLE;INJECTION - 200MG/100ML

    USFDA APPLICATION NUMBER - 50629

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    DOSAGE - INJECTABLE;INJECTION - 2MG/ML

    USFDA APPLICATION NUMBER - 50629

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    DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20MG/10ML (2MG/ML)

    USFDA APPLICATION NUMBER - 50718

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    DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50MG/25ML (2MG/ML)

    USFDA APPLICATION NUMBER - 50718

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    ABOUT THIS PAGE

    Doxorubicin Hydrochloride Manufacturers

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

    Doxorubicin Hydrochloride Suppliers

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

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

    Doxorubicin Hydrochloride USDMF

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

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

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

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

    Doxorubicin Hydrochloride KDMF

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

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

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

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

    Doxorubicin Hydrochloride CEP

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

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

    Doxorubicin Hydrochloride WC

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

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

    Doxorubicin Hydrochloride 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 Doxorubicin Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Doxorubicin Hydrochloride GMP

    Doxorubicin Hydrochloride 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 Doxorubicin Hydrochloride 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 Doxorubicin Hydrochloride GMP manufacturer or Doxorubicin Hydrochloride GMP API supplier for your needs.

    Doxorubicin Hydrochloride CoA

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

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

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