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pfizer centreone dexamethasone sodium phosphate

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 15 USDMF, 5 CEP/COS, 3 JDMF, 3 EU WC, 5 KDMF, 15 NDC API, 30 Listed Suppliers, $ API Reference Price

45 API Suppliers
15 USDMF
5 CEP/COS
3 JDMF
3 EU WC
5 KDMF
15 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

138 FDF Dossiers, 68 FDA Orange Book, 25 Europe, 14 Canada, 4 South Africa, 27 Listed Dossiers

138 FDF Dossiers
68 FDA Orange Book
25 Europe
14 Canada
4 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML, INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML

drugProductComposition
INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML
INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML

RELATED EXCIPIENT COMPANIES

1 Jai Radhe Sales, 2 Nanjing Well Pharmaceutical, 12 Actylis, 1 BASF, 3 Finar, 3 Gangwal Chemicals, 1 Nanjing Bold Chemical, 6 Seppic

relatedExcipients
1 Jai Radhe Sales
2 Nanjing Well Pharmaceutical
12 Actylis
1 BASF
3 Finar
3 Gangwal Chemicals
1 Nanjing Bold Chemical
6 Seppic

EXCIPIENTS BY APPLICATIONS

13 Solubilizers, 11 Parenteral, 6 Topical, 4 Controlled & Modified Release, 3 Emulsifying Agents, 2 Thickeners and Stabilizers, 2 Film Formers & Plasticizers, 2 Surfactant & Foaming Agents, 1 Co-Processed Excipients, 1 Direct Compression, 1 Rheology Modifiers, 1 API Stability Enhancers

excipientsByApplications
13 Solubilizers
11 Parenteral
6 Topical
4 Controlled & Modified Release
3 Emulsifying Agents
2 Thickeners and Stabilizers
2 Film Formers & Plasticizers
2 Surfactant & Foaming Agents
1 Co-Processed Excipients
1 Direct Compression
1 Rheology Modifiers
1 API Stability Enhancers

DIGITAL CONTENT

28 NEWS #PharmaBuzz

media
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
25 Finished Drug Prices

MARKET PLACE

35 APIs, 10 FDF Dossiers

marketPlace
35 APIs
10 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM , 2 USP , 1 Others

otherSolutions
4 EDQM
2 USP
1 Others

EUROAPI Dexamethasone Sodium Phosphate

Synopsis

ACTIVE PHARMA INGREDIENTS

45

API Suppliers

15

USDMF

5

CEP/COS

CEP/COS Certifications

3

JDMF

3

EU WC

5

KDMF

15

NDC API

0

VMF

30

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 1,005

MARKET PLACE

35

API

10

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

138

FDF Dossiers

68

FDA Orange Book

FDA (Orange Book)

25

Europe

14

Canada

0

Australia

4

South Africa

27

Listed Dossiers

22DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

4

EDQM

2

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

28

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

44,947

Annual Reports (USD Million)

NA

Finished Drug Prices

29 RELATED EXCIPIENT COMPANIES

47EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 2392-39-4, Dexamethasone 21-phosphate disodium salt, Dalalone, Dexadreson, Dexamethasone disodium phosphate, Megacort

Molecular Formula

C₂₂H₂₈FNa₂O₈P

Molecular Weight

516.4 g/mol

InChI Key

PLCQGRYPOISRTQ-FCJDYXGNSA-L

FDA UNII

AI9376Y64P

Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate is a sodium phosphate salt form of Dexamethasone, a synthetic adrenal corticosteroid with potent anti-inflammatory properties. In addition to binding to specific nuclear steroid receptors, dexamethasone also interferes with NF-kB activation and apoptotic pathways. This agent lacks the salt-retaining properties of other related adrenal hormones. (NCI04)

1 2D Structure

Dexamethasone Sodium Phosphate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

disodium;[2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate

2.1.2 InChI

InChI=1S/C22H30FO8P.2Na/c1-12-8-16-15-5-4-13-9-14(24)6-7-19(13,2)21(15,23)17(25)10-20(16,3)22(12,27)18(26)11-31-32(28,29)30;;/h6-7,9,12,15-17,25,27H,4-5,8,10-11H2,1-3H3,(H2,28,29,30);;/q;2*+1/p-2/t12-,15+,16+,17+,19+,20+,21+,22+;;/m1../s1

2.1.3 InChI Key

PLCQGRYPOISRTQ-FCJDYXGNSA-L

2.1.4 Canonical SMILES

CC1CC2C3CCC4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)COP(=O)([O-])[O-])O)C)O)F)C.[Na+].[Na+]

2.1.5 Isomeric SMILES

C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)COP(=O)([O-])[O-])O)C)O)F)C.[Na+].[Na+]

2.2 Other Identifiers

2.2.1 UNII

AI9376Y64P

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Decadron Phosphate

2. Dexamethasone 21-phosphate

3. Dexamethasone 21-phosphate, (6alpha,11beta,16alpha)-isomer

4. Dexamethasone 21-phosphate, Copper (+2) Salt (2:3), (11beta,16alpha)-isomer

5. Dexamethasone 21-phosphate, Disodium Salt, (11beta,16alpha)-isomer

6. Dexamethasone 21-phosphate, Disodium Salt, (6alpha,11beta,16alpha)-isomer

7. Dexamethasone 21-phosphate, Monosodium Salt, (11beta,16alpha)-isomer

8. Dexamethasone 21-phosphate, Sodium Salt, (11beta,16alpha)-isomer

9. Dexamethasone Phosphate

10. Dexamethasone Phosphate Disodium Salt

11. Dexamethasonedisodium Phosphate

12. Solu- Decadron

13. Spersadex

14. Spersadox

2.3.2 Depositor-Supplied Synonyms

1. 2392-39-4

2. Dexamethasone 21-phosphate Disodium Salt

3. Dalalone

4. Dexadreson

5. Dexamethasone Disodium Phosphate

6. Megacort

7. Soldesam

8. Dexagro

9. 55203-24-2

10. Decadron Phosphate

11. Dexabene

12. Orgadrone

13. Ak-dex

14. Sodium Dexamethasone Phosphate

15. Dexamethasone 21-(disodium Phosphate)

16. Dexamethasone Phosphate Disodium

17. 2392-39-4 (disodium)

18. Chebi:4462

19. Tlc399

20. Tlc-399

21. Ai9376y64p

22. Nsc-756722

23. Disodium;[2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Phosphate

24. Spersadox

25. Decdan

26. Solu-decadron

27. Maxidex Ointment

28. Dsstox_cid_27429

29. Dsstox_rid_82342

30. Dsstox_gsid_47429

31. Hexadrol Injectable

32. Disodium [2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Phosphate

33. Colvasone

34. Dexagel

35. Onadron

36. Baldex

37. Mfcd00079105

38. Dexaject Sp

39. Egp 437

40. Sodium 2-((8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Phosphate

41. Cas-2392-39-4

42. Disodium Dexamethasone Phosphate

43. 21-disodium Phosphate Dexamethasone

44. Einecs 219-243-0

45. Dexamethasone-21-phosphate Disodium Salt

46. Dexamethazone Sodium Phosphate

47. Unii-ai9376y64p

48. Ncgc00094644-01

49. Dalalone (tn)

50. Mephamesone

51. Soludecadron

52. Totocortin

53. Solupen N

54. Egp437. Dex-phos

55. Dexamethasone Sodium Phosphate [usp:ban:jan]

56. Schembl7778

57. Decadron Inhalation, Injection, Ophthalmic Solution And Ointment, And Topical Cream

58. 9-fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen Phosphate) Disodium Salt

59. Chembl2021430

60. Dtxsid3047429

61. Dexamethasone Phosphate Sodium Salt

62. Bcp16805

63. Tox21_113181

64. Tox21_302586

65. S4028

66. Akos015896357

67. Akos015951212

68. Am84812

69. Ccg-269820

70. Ks-1150

71. Nsc 756722

72. Ncgc00256783-01

73. Ac-17992

74. Dexamethasone Sodium Phosphate (jan/usp)

75. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Disodium Salt, (11.beta.,16.alpha.)-

76. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Disodium Salt, (11beta,16alpha)-

77. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen Phosphate) Disodium Salt

78. Dexamethasone Phosphate (as Sodium)

79. Dexamethasone Sodium Phosphate [jan]

80. B1588

81. Dexamethasone Sodium Phosphate [mart.]

82. Dexamethasone Sodium Phosphate [vandf]

83. En300-52795

84. C08175

85. D00975

86. Dexamethasone Sodium Phosphate [usp-rs]

87. Dexamethasone Sodium Phosphate [who-dd]

88. Dexamethasone Sodium Phosphate [who-ip]

89. A816989

90. A830522

91. Dexamethasone 21-phosphate Disodium Salt, >=98%

92. Dexamethasone Sodium Phosphate [green Book]

93. Dexamethasone Sodium Phosphate [orange Book]

94. Dexamethasone Sodium Phosphate [usp Impurity]

95. Dexamethasoni Natrii Phosphas [who-ip Latin]

96. Dexamethasone 21-phosphate Disodium Salt [mi]

97. Dexamethasone Sodium Phosphate [usp Monograph]

98. Q27106391

99. Neodecadron Component Dexamethasone Sodium Phosphate

100. Dexamethasone Sodium Phosphate Component Of Neodecadron

101. Dexamethasone Sodium Phosphate, British Pharmacopoeia (bp) Reference Standard

102. Dexamethasone Sodium Phosphate, European Pharmacopoeia (ep) Reference Standard

103. Dexamethasone Sodium Phosphate, United States Pharmacopeia (usp) Reference Standard

104. 9-fluoro-11.beta.,17,21-trihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen Phosphate) Disodium Salt

105. Dexamethasone Sodium Phosphate For Peak Identification, European Pharmacopoeia (ep) Reference Standard

106. Dexamethasone Sodium Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material

107. Disodium [2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] Phosphate

108. Disodium 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl Phosphate

109. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Sodium Salt (1:2), (11beta,16alpha)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₈FNa₂O₈P
Molecular Weight	516.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	3
Exact Mass	516.13012157 g/mol
Monoisotopic Mass	516.13012157 g/mol
Topological Polar Surface Area	147 Å²
Heavy Atom Count	34
Formal Charge	0
Complexity	962
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Dexamethasone sodium phosphate
Drug Label	Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water....
Active Ingredient	Dexamethasone sodium phosphate
Dosage Form	Injectable; Solution/drops
Route	Ophthalmic, otic; Injection
Strength	eq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml
Market Status	Prescription
Company	Fresenius Kabi Usa; Hikma Maple; Bausch And Lomb; Alcon Pharms; Luitpold; Agila Speclts

2 of 2
Drug Name	Dexamethasone sodium phosphate
Drug Label	Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water....
Active Ingredient	Dexamethasone sodium phosphate
Dosage Form	Injectable; Solution/drops
Route	Ophthalmic, otic; Injection
Strength	eq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml
Market Status	Prescription
Company	Fresenius Kabi Usa; Hikma Maple; Bausch And Lomb; Alcon Pharms; Luitpold; Agila Speclts

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

API SUPPLIERS

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USDMF

01

Euroapi France

France

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Digital Content

Dexamethasone Sodium Phosphate

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-28

Pay. Date : 2013-01-16

DMF Number : 3963

Submission : 1980-10-10

Status : Active

Type : II

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02

Pharmacia And Upjohn Co Llc Wholly O...

U.S.A

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U.S.A

Digital Content

Dexamethasone Sodium Phosphate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2022-03-04

Pay. Date : 2022-02-28

DMF Number : 6525

Submission : 1986-08-11

Status : Active

Type : II

Pfizer centreOne

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03

Antibioticos Spa

Italy

Compamed

Not Confirmed

04

Antibioticos Spa

Italy

Compamed

Not Confirmed

05

Compania Espanola De Sintesis Quimic...

Argentina

Compamed

Not Confirmed

06

Diosynth Bv

United Kingdom

Compamed

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07

Organon Inc

U.S.A

Compamed

Not Confirmed

08

Societa Italiana Corticosteroidi Spa

Italy

Compamed

Not Confirmed

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CEP/COS

01

EUROAPI FRANCE Vertolaye FR

France

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Dexamethasone sodium phosphate

Certificate Number : R2-CEP 1992-014 - Rev 07

Status : Valid

Issue Date : 2021-12-16

Type : Chemical

Substance Number : 549

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PHARMACIA & UPJOHN COMPANY LLC Kala...

U.S.A

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U.S.A

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Dexamethasone sodium phosphate

Certificate Number : R1-CEP 1998-154 - Rev 06

Status : Valid

Issue Date : 2021-07-07

Type : Chemical

Substance Number : 549

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CURIA SPAIN S.A.U. Boecillo ES

U.S.A

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SYMBIOTICA SPECIALITY INGREDIENTS S...

Malaysia

Compamed

Not Confirmed

05

TIANJIN TIANYAO PHARMACEUTICALS CO....

China

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Not Confirmed

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

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

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DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPH...DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML

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