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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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CORP.,109 BA WEI ROAD, HEDONG DISTRICT, TIANJIN 300 171, P.R OF CHINA., CHINA","customerAddress":"401, BAANI, 1,,GOLF COURSE ROAD, S"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"DEXAMETHASONE SODIUM PHOSPHATE EP\/USP DEXAMETHASONE SODIUM PHOSPHATE EP\/USP","address":"110-B,ANDHERI INDUSTRIAL ESTATE","city":"ANDHERI(W),MUMBAI, MAHARASHTRA","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ADD BIOTEC","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"520","totalValueFC":"26300.2","currency":"USD","unitRateINR":"44694","date":"23-Dec-2024","totalValueINR":"2234700","totalValueInUsd":"26300.2","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"7404127","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT TI ANJIN Tianjin - 300171, , CHINA SDNF CHINA","customerAddress":"110-B,ANDHERI INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737138600,"product":"DEXAMETHASONE SODIUM PHOSPHATE EP DEXAMETHASONE SODIUM PHOSPHATE","address":"5\/2-INDUSTRIAL AREA","city":"NEW DELHI","supplier":"ZHEJIANG XIANJU PHARMACEUTICAL CO. LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"INDUS PHARMA","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"498.3","totalValueFC":"30198.6","currency":"USD","unitRateINR":"43400","date":"18-Jan-2025","totalValueINR":"2604000","totalValueInUsd":"30198.6","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"7863442","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"NO.1 XIANYAO ROAD,XIANJU ZHEJIANG C HINA , , CHINA SDNF CHINA","customerAddress":"5\/2-INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739125800,"product":"DEXAMETHASONE SODIUM PHOSPHATE IP DEXAMETHASONE SODIUM PHOSPHATE IP","address":"\\\"A\\\"BLOCK,SHIV SAGAR ESTATE,","city":"BOMBAY 18 ,","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"520","totalValueFC":"52858.6","currency":"USD","unitRateINR":"45968","date":"10-Feb-2025","totalValueINR":"4596800","totalValueInUsd":"52858.6","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"8265668","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT, T IANJIN 300 171 Beijing, China SDNF China","customerAddress":"\\\"A\\\"BLOCK,SHIV SAGAR ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739125800,"product":"DEXAMETHASONE SODIUM PHOSPHATE IP2024, BATCH: NEDNA241107,Y.O.M: 05.11.2024, Y.O.E: 04.11.2029DEXAMETHASONE SODIUM PHOSPHATE IP2024","address":"401, BAANI, 1,,GOLF COURSE ROAD, S","city":"GURGAON,HARYANA","supplier":"TIANJIN TIANFA PHARMACEUTICAL IMPORT & EXPORT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"NICHEPHARM LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"49.00","actualQuantity":"49","unit":"KGS","unitRateFc":"530","totalValueFC":"26398.8","currency":"USD","unitRateINR":"46852","date":"10-Feb-2025","totalValueINR":"2295748","totalValueInUsd":"26398.8","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"8277889","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"& EXP. CORP.,109 BA WEI ROAD, HEDONG DISTRICT, TIANJIN 300171, CHINA., CHINA","customerAddress":"401, BAANI, 1,,GOLF COURSE ROAD, S"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"DEXAMETHASONE SODIUM PHOSPHATE (BATCH NO. C0112\/0 24110) DEXAMETHASONE SODIUM PHOSPHATE (BATCH NO. C0112\/0 24110)","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"12.5","totalValueFC":"2534.8","currency":"USD","unitRateINR":"1097.8","date":"10-Mar-2025","totalValueINR":"219554.88","totalValueInUsd":"2534.8","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"8808776","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"VALLODOLID SPAIN PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLODOLID ES","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742409000,"product":"DEXAMETHASONE SODIUM PHOSPHATE USP DEXAMETHASONE SODIUM PHOSPHATE USP","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"EUROAPI","supplierCountry":"FRANCE","foreign_port":"LYON","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"5226.4","totalValueFC":"42382.2","currency":"EUR","unitRateINR":"458880","date":"20-Mar-2025","totalValueINR":"3671040","totalValueInUsd":"42382.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8995445","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"LYON","supplierAddress":"15 RUE TRAVERSIERE 75012 PARIS FRANCE FR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"}]
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31-Mar-2025
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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)

Spersadex Manufacturers

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

Spersadex Suppliers

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

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

Spersadex USDMF

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

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

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

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

Spersadex KDMF

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

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

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

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

Spersadex CEP

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

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

Spersadex WC

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

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

Spersadex 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 Spersadex as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Spersadex GMP

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

Spersadex CoA

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

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

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