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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 Weight 516.4 g/mol
Molecular Formula C22H28FNa2O8P
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count9
Rotatable Bond Count3
Exact Mass516.13012157 g/mol
Monoisotopic Mass516.13012157 g/mol
Topological Polar Surface Area147 Ų
Heavy Atom Count34
Formal Charge0
Complexity962
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameDexamethasone sodium phosphate
Drug LabelDexamethasone 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 IngredientDexamethasone sodium phosphate
Dosage FormInjectable; Solution/drops
RouteOphthalmic, otic; Injection
Strengtheq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml
Market StatusPrescription
CompanyFresenius Kabi Usa; Hikma Maple; Bausch And Lomb; Alcon Pharms; Luitpold; Agila Speclts

2 of 2  
Drug NameDexamethasone sodium phosphate
Drug LabelDexamethasone 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 IngredientDexamethasone sodium phosphate
Dosage FormInjectable; Solution/drops
RouteOphthalmic, otic; Injection
Strengtheq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml
Market StatusPrescription
CompanyFresenius 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]

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

Status : Valid

Issue Date : 2021-07-07

Type : Chemical

Substance Number : 549

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

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Issue Date : 2021-12-16

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10-Jan-2022
30-Apr-2025
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Europe

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01

Galepharm AG

Turkey
The Battery Show Europe
Not Confirmed
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Galepharm AG

Turkey
arrow
The Battery Show Europe
Not Confirmed

Dexamethasone dihydrogenophosphas

Brand Name : Dexamethasone Galepharm Amp

Dosage Form : Inj Sol

Dosage Strength : 4mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

Galepharm AG

Turkey
The Battery Show Europe
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Galepharm AG

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Dexamethasone dihydrogenophosphas

Brand Name : Dexamethasone Galepharm Amp

Dosage Form : Inj Sol

Dosage Strength : 8mg/2ml

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Approval Date :

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Regulatory Info :

Registration Country : Switzerland

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Galepharm AG

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Galepharm AG

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Dexamethasone dihydrogenophosphas

Brand Name : Dexamethasone Galepharm Amp

Dosage Form : Inj Sol

Dosage Strength : 4mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Dexamethasone sodium phosphate

Brand Name : Dexamethasone phosphate Hameln

Dosage Form : Solution for injection

Dosage Strength : 4 mg/ml

Packaging : Ampoule av glass 10 1ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Dexamethasone sodium phosphate

Brand Name : Dexamethasone phosphate Hameln

Dosage Form : Solution for injection

Dosage Strength : 4 mg/ml

Packaging : Ampoule av glass 10 2ml

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Application Number :

Regulatory Info :

Registration Country : Norway

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dexamethasone sodium phosphate

Brand Name : Dexafree

Dosage Form : EYE DROPS, SOLUTION

Dosage Strength : 1 MG / ML

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Regulatory Info :

Registration Country : Sweden

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SIT LABORATORIO FARMAC. Srl

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Dexamethasone 21-Phosphate

Brand Name : Cortiarscolloid

Dosage Form :

Dosage Strength : Collut 20 G  

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Regulatory Info :

Registration Country : Italy

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Dexamethasone 21-Phosphate

Brand Name : Cortiarscolloid

Dosage Form :

Dosage Strength : Concentrated 10 G  

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Regulatory Info :

Registration Country : Italy

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Abboxia AB

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Abboxia AB

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Dexamethasone sodium phosphate

Brand Name : Dexacur

Dosage Form : Solution for injection/infusion

Dosage Strength : 4 mg/ml

Packaging : Ampoule av glass 3 1ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Abboxia AB

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Abboxia AB

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Dexamethasone sodium phosphate

Brand Name : Dexacur

Dosage Form : Solution for injection/infusion

Dosage Strength : 4 mg/ml

Packaging : Ampoule av glass 3 2ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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DRUG PRODUCT COMPOSITIONS

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

USFDA APPLICATION NUMBER - 84916

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

USFDA APPLICATION NUMBER - 87440

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ABOUT THIS PAGE

Looking for 2392-39-4 / Dexamethasone Sodium Phosphate API manufacturers, exporters & distributors?

Dexamethasone Sodium Phosphate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier for your needs.

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

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

API | Excipient name

Dexamethasone Sodium Phosphate

Synonyms

2392-39-4, Dexamethasone 21-phosphate disodium salt, Dalalone, Dexadreson, Dexamethasone disodium phosphate, Megacort

Cas Number

2392-39-4

Unique Ingredient Identifier (UNII)

AI9376Y64P

About 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)

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream Manufacturers

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

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream Suppliers

A Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream supplier is an individual or a company that provides Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream active pharmaceutical ingredient (API) or Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream finished formulations upon request. The Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers may include Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream API manufacturers, exporters, distributors and traders.

click here to find a list of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream USDMF

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

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

click here to find a list of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with USDMF on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream Drug Master File in Japan (Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream JDMF) empowers Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream JDMF during the approval evaluation for pharmaceutical products. At the time of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with JDMF on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream KDMF

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

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

After submitting a Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with KDMF on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream CEP

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

A Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with CEP (COS) on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream WC

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

click here to find a list of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with Written Confirmation (WC) on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream suppliers with NDC on PharmaCompass.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream GMP

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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 Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream GMP manufacturer or Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream GMP API supplier for your needs.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream CoA

A Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream CoA (Certificate of Analysis) is a formal document that attests to Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream's compliance with Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream specifications and serves as a tool for batch-level quality control.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream CoA mostly includes findings from lab analyses of a specific batch. For each Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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.

Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream may be tested according to a variety of international standards, such as European Pharmacopoeia (Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream EP), Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream 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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