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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]

    API Reference Price

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SDNF China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733682600,"product":"DEXAMETHASONE SODIUM PHOSPHATE IP DEXAMETHASONE SODIUM PHOSPHATE IP","address":"\\\"A\\\"BLOCK,SHIV SAGAR ESTATE,","city":"BOMBAY 18 ,","supplier":"TIANJIN TIANFA PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"520","totalValueFC":"78625.2","currency":"USD","unitRateINR":"44538","date":"09-Dec-2024","totalValueINR":"6680700","totalValueInUsd":"78625.2","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"7138599","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":"2024","qtr":"Q4","strtotime":1734287400,"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":"PARIS - CHARLES DE G","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"5091.4","totalValueFC":"10264.5","currency":"USD","unitRateINR":"436080","date":"16-Dec-2024","totalValueINR":"872160","totalValueInUsd":"10264.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7276707","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"4, LA PATERIE 63480 VERTOLAYE, FRAN CE, SDNF France","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"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 PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"NICHEPHARM LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.05","actualQuantity":"1.05","unit":"KGS","unitRateFc":"504.8","totalValueFC":"536.1","currency":"USD","unitRateINR":"43384.3","date":"20-Dec-2024","totalValueINR":"45553.5","totalValueInUsd":"536.1","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"7351470","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"IMP. & EXP. CORP.,109 BA WEI ROAD, HEDONG DISTRICT, TIANJIN 300 171, 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 PHARMACEUTICALS","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"}]
    13-Jan-2021
    30-Dec-2024
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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

    98

    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)

    Dexamethasone Sodium Phosphate Manufacturers

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

    Dexamethasone Sodium Phosphate Suppliers

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

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

    Dexamethasone Sodium Phosphate USDMF

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

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

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

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

    Dexamethasone Sodium Phosphate KDMF

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

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

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

    click here to find a list of Dexamethasone Sodium Phosphate suppliers with KDMF on PharmaCompass.

    Dexamethasone Sodium Phosphate CEP

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

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

    Dexamethasone Sodium Phosphate WC

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

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

    Dexamethasone Sodium 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 Dexamethasone Sodium Phosphate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dexamethasone Sodium Phosphate GMP

    Dexamethasone Sodium 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 Dexamethasone Sodium 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 Dexamethasone Sodium Phosphate GMP manufacturer or Dexamethasone Sodium Phosphate GMP API supplier for your needs.

    Dexamethasone Sodium Phosphate CoA

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

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

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