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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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EUR.","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"SYNBIAS PHARMA AG","supplierCountry":"GERMANY","foreign_port":"HAMBURG - FUHLSBUETT","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2000","unit":"GMS","unitRateFc":"35","totalValueFC":"70706.9","currency":"USD","unitRateINR":"3048.5","date":"31-Jan-2025","totalValueINR":"6097000","totalValueInUsd":"70706.9","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"8104276","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"Pestalozzistrasse 2 CH-8200 Schaffh ausen, Switzerland Switzerland, , S witzerland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739989800,"product":"DOXORUBICIN HYDROCHLORIDE USP. EUR. BATCH :DR 140324 , DR 160324. MFG. MARCH 2024 , APRIL 2024 RETEST FEBRUARY 2027 , MADOXORUBICIN HYDROCHLORIDE PH. EUR. BATCH:DR 120224 , DR 1303","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"SYNBIAS PHARMA AG","supplierCountry":"SWITZERLAND","foreign_port":"HAMBURG - FUHLSBUETT","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"35000","totalValueFC":"71155.8","currency":"USD","unitRateINR":"3094000","date":"20-Feb-2025","totalValueINR":"6188000","totalValueInUsd":"71155.8","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"8472285","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"Pestalozzistrasse 2 CH-8200 Schaffh ausen, Switzerland Schaffhausen, , SWITZERLAND SWITZERLAND","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"DOXORUBICIN HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TAPI NL BV","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2000","unit":"GMS","unitRateFc":"51","totalValueFC":"102803.6","currency":"USD","unitRateINR":"4452.3","date":"27-Mar-2025","totalValueINR":"8904600","totalValueInUsd":"102803.6","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29419019","bill_no":"9129653","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"piet Heinkade 55 1019 Gm amsterdam the netherlands SDNF Italy","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"}]
24-Jan-2022
15-May-2025
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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

Looking for 25316-40-9 / Doxorubicin Hydrochloride API manufacturers, exporters & distributors?

Doxorubicin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Doxorubicin Hydrochloride

Synonyms

25316-40-9, Doxorubicin hcl, Rubex, Adriacin, Adriblastina, Caelyx

Cas Number

25316-40-9

Unique Ingredient Identifier (UNII)

82F2G7BL4E

About Doxorubicin Hydrochloride

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.

Adriblastine Manufacturers

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

Adriblastine Suppliers

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

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

Adriblastine USDMF

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

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

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

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

Adriblastine KDMF

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

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

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

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

Adriblastine CEP

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

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

Adriblastine WC

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

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

Adriblastine 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 Adriblastine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Adriblastine GMP

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

Adriblastine CoA

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

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

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