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Chemistry

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Also known as: 75607-67-9, Fludara, Fludarabine 5'-monophosphate, Oforta, Fludarabine monophosphate, 2-fluoro-ara amp
Molecular Formula
C10H13FN5O7P
Molecular Weight
365.21  g/mol
InChI Key
GIUYCYHIANZCFB-FJFJXFQQSA-N
FDA UNII
1X9VK9O1SC

Fludarabine Phosphate
1 2D Structure

Fludarabine Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R,3S,4S,5R)-5-(6-amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate
2.1.2 InChI
InChI=1S/C10H13FN5O7P/c11-10-14-7(12)4-8(15-10)16(2-13-4)9-6(18)5(17)3(23-9)1-22-24(19,20)21/h2-3,5-6,9,17-18H,1H2,(H2,12,14,15)(H2,19,20,21)/t3-,5-,6+,9-/m1/s1
2.1.3 InChI Key
GIUYCYHIANZCFB-FJFJXFQQSA-N
2.1.4 Canonical SMILES
C1=NC2=C(N=C(N=C2N1C3C(C(C(O3)COP(=O)(O)O)O)O)F)N
2.1.5 Isomeric SMILES
C1=NC2=C(N=C(N=C2N1[C@H]3[C@H]([C@@H]([C@H](O3)COP(=O)(O)O)O)O)F)N
2.2 Other Identifiers
2.2.1 UNII
1X9VK9O1SC
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 9 Beta-d-arabinofuranosyl-2-fluoroadenine Monophosphate

2. 9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-

3. Beneflur

4. F-ara-amp

5. Faraamp

6. Fludara

7. Fludarabine 5'-monophosphate

8. Fludarabine Monophosphate

9. Fluoro-ara-amp

10. Nsc 312887

11. Nsc-312887

2.3.2 Depositor-Supplied Synonyms

1. 75607-67-9

2. Fludara

3. Fludarabine 5'-monophosphate

4. Oforta

5. Fludarabine Monophosphate

6. 2-fluoro-ara Amp

7. 2-f-ara-amp

8. Fludarabine (phosphate)

9. Famp

10. Nsc-312887

11. 2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-9h-purin-6-amine

12. ((2r,3s,4s,5r)-5-(6-amino-2-fluoro-9h-purin-9-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methyl Dihydrogen Phosphate

13. Chebi:63599

14. 2-fluoroadenine Arabinoside 5'-monophosphate

15. 1x9vk9o1sc

16. 9-beta-arabinofuranosyl-2-fluoroadenine-5'-phosphate

17. 9-beta-d-arabinofuranosyl-2-fluoroadenine 5'-monophosphate

18. 75607-67-9 (phosphate)

19. 9-beta-d-arabinofuranosyl-2-fluoroadenine 5'-(dihydrogen Phosphate)

20. Fludarabine Phosphate (fludara)

21. {[(2r,3s,4s,5r)-5-(6-amino-2-fluoro-9h-purin-9-yl)-3,4-dihydroxyoxolan-2-yl]methoxy}phosphonic Acid

22. Nsc 312887

23. Nsc 328002

24. [(2r,3s,4s,5r)-5-(6-amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl Dihydrogen Phosphate

25. Nsc-328002

26. Smr002544683

27. F-ara-amp

28. Sr-05000001945

29. Unii-1x9vk9o1sc

30. Beneflur

31. Fludara Phosphate

32. Fludara (tn)

33. Fludarabine-phosphate

34. 2-fluoro-ara-amp

35. Mfcd00866418

36. Fludarabine Phosphate [usan:usp:ban]

37. Fludarabine Phosphate;

38. 2f-ara-amp

39. Schembl3511

40. Nsc 312887 Phosphate

41. Mls003915617

42. Mls004774150

43. 9-bata-d-arabinofuranosyl-2-fluoroadenine Phosphate

44. Fludarabine Phosphate(fludara)

45. 9-.beta.-d-arabinofuranosyl-2-fluoroadenine 5'-(dihydrogen Phosphate)

46. Chembl1096882

47. Dtxsid2023060

48. Fludarabine Phosphate (jan/usp)

49. Sht-586

50. Fludarabine For System Suitability

51. Hms2094o11

52. Pharmakon1600-01505705

53. Fludarabine Phosphate [jan]

54. Ex-a2028

55. Hy-b0028

56. Nsc-118218h

57. Zinc3927870

58. Fludarabine Phosphate [usan]

59. Bdbm50248004

60. Fludarabine Phosphate [vandf]

61. Hg1010

62. Nsc759194

63. S1229

64. Fludarabine Phosphate [mart.]

65. 9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-

66. Akos024464516

67. Fludarabine Phosphate [usp-rs]

68. Fludarabine Phosphate [who-dd]

69. Bcp9000694

70. Ccg-213521

71. Cs-0861

72. F-ara-a (nsc 312887) Phosphate

73. Nsc-759194

74. Sri-5907-04

75. Sri-5907_05

76. Sri-5907_07

77. As-14202

78. Bcp0726000268

79. Fludarabine 5'-monophosphate [mi]

80. Fludarabine Phosphate [orange Book]

81. Sbi-0206893.p001

82. Fludarabine Phosphate [ep Monograph]

83. Fludarabine Phosphate [usp Monograph]

84. Sw218146-2

85. D01907

86. 607f679

87. A838460

88. Q185916

89. Sr-05000001945-1

90. Sr-05000001945-4

91. Z2235802254

92. 9-beta-d-arabinofuranosyl-2-fluoroadenine-5'-monophosphate

93. 9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-b-d-arabinofuranosyl)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 365.21 g/mol
Molecular Formula C10H13FN5O7P
XLogP3-3.1
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count12
Rotatable Bond Count4
Exact Mass365.05366293 g/mol
Monoisotopic Mass365.05366293 g/mol
Topological Polar Surface Area186 Ų
Heavy Atom Count24
Formal Charge0
Complexity514
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFludarabine phosphate
Drug LabelFludarabine Phosphate Injection contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9- D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each mL cont...
Active IngredientFludarabine phosphate
Dosage FormInjectable
RouteInjection
Strength50mg/2ml (25mg/ml); 50mg/vial
Market StatusPrescription
CompanyHospira; Teva Pharms Usa; Sandoz; Actavis Elizabeth; Mustafa Nevzat Ilac; Fresenius Kabi Usa; Onco Therapies

2 of 2  
Drug NameFludarabine phosphate
Drug LabelFludarabine Phosphate Injection contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9- D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each mL cont...
Active IngredientFludarabine phosphate
Dosage FormInjectable
RouteInjection
Strength50mg/2ml (25mg/ml); 50mg/vial
Market StatusPrescription
CompanyHospira; Teva Pharms Usa; Sandoz; Actavis Elizabeth; Mustafa Nevzat Ilac; Fresenius Kabi Usa; Onco Therapies

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antimetabolites, Antineoplastic

Antimetabolites that are useful in cancer chemotherapy. (See all compounds classified as Antimetabolites, Antineoplastic.)


Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Nucleoside Metabolic Inhibitor [EPC]; Nucleic Acid Synthesis Inhibitors [MoA]

API Reference Price

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12-Jun-2021
08-Nov-2024
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ABOUT THIS PAGE

Fludarabine Phosphate Manufacturers

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

Fludarabine Phosphate Suppliers

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

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

Fludarabine Phosphate USDMF

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

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

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

Fludarabine Phosphate CEP

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

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

Fludarabine Phosphate 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 Fludarabine Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fludarabine Phosphate GMP

Fludarabine Phosphate 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 Fludarabine Phosphate 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 Fludarabine Phosphate GMP manufacturer or Fludarabine Phosphate GMP API supplier for your needs.

Fludarabine Phosphate CoA

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

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

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