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Chemistry

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Also known as: Cortisone 21-acetate, 50-04-4, Cortone acetate, Incortin, Biocort acetate, Artriona
Molecular Formula
C23H30O6
Molecular Weight
402.5  g/mol
InChI Key
ITRJWOMZKQRYTA-RFZYENFJSA-N
FDA UNII
883WKN7W8X

Cortisone
A naturally occurring glucocorticoid that has been used in replacement therapy for ADRENAL INSUFFICIENCY and as an anti-inflammatory agent. Cortisone itself is inactive; it is converted in the liver to the active metabolite HYDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p726)
1 2D Structure

Cortisone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-[(8S,9S,10R,13S,14S,17R)-17-hydroxy-10,13-dimethyl-3,11-dioxo-1,2,6,7,8,9,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
2.1.2 InChI
InChI=1S/C23H30O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h10,16-17,20,28H,4-9,11-12H2,1-3H3/t16-,17-,20+,21-,22-,23-/m0/s1
2.1.3 InChI Key
ITRJWOMZKQRYTA-RFZYENFJSA-N
2.1.4 Canonical SMILES
CC(=O)OCC(=O)C1(CCC2C1(CC(=O)C3C2CCC4=CC(=O)CCC34C)C)O
2.1.5 Isomeric SMILES
CC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(CC(=O)[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C)O
2.2 Other Identifiers
2.2.1 UNII
883WKN7W8X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 17-hydroxy-3,11,20-trioxopregn-4-en-21-yl Acetate

2. Adreson

3. Cortisone

4. Cortone Acetate

2.3.2 Depositor-Supplied Synonyms

1. Cortisone 21-acetate

2. 50-04-4

3. Cortone Acetate

4. Incortin

5. Biocort Acetate

6. Artriona

7. Cortadren

8. Scheroson

9. Cortisyl

10. Adreson

11. Irisone Acetate

12. Cortelan

13. Cortistab

14. Ricortex

15. Cortogen Acetate

16. Compound E Acetate

17. Pregn-4-ene-3,11,20-trione, 21-(acetyloxy)-17-hydroxy-

18. Cortisone Monoacetate

19. Nsc 49420

20. Cortisone, 21-acetate

21. Cortilen

22. Cortisone Aceticum

23. 11-dehydro-17-hydroxycorticosterone-21-acetate

24. 11-dehydro-17-hydroxycorticosterone Acetate

25. 17,21-dihydroxypregn-4-ene-3,11,20-trione 21-acetate

26. Nsc-49420

27. 883wkn7w8x

28. Chebi:3897

29. Pregn-4-ene-3,11,20-trione, 17,21-dihydroxy-, 21-acetate

30. Cortisone (acetate)

31. Ncgc00021191-07

32. 17-hydroxy-3,11,20-trioxopregn-4-en-21-yl Acetate

33. Dsstox_cid_2858

34. Dsstox_rid_76761

35. Dsstox_gsid_22858

36. 17,21-dihydroxypregn-4-ene-3,11,20-trione-21-acetate

37. 17alpha,21-dihydroxypregn-4-ene-3,11,20-trione Acetate

38. Cas-50-04-4

39. [2-[(8s,9s,10r,13s,14s,17r)-17-hydroxy-10,13-dimethyl-3,11-dioxo-1,2,6,7,8,9,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate

40. 2-((8s,9s,10r,13s,14s,17r)-17-hydroxy-10,13-dimethyl-3,11-dioxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate

41. Smr000059124

42. Ccris 3661

43. Cortisone Acetate (cortone)

44. Einecs 200-006-5

45. Unii-883wkn7w8x

46. Cortisoneacetate

47. Cortisone Acetate [usp:jan]

48. Acetate Cortisone

49. Cortisyl Artriona

50. Component Of Neosone

51. Mfcd00003609

52. Neosone (salt/mix)

53. 21-(acetyloxy)-17-hydroxypregn-4-ene-3,11,20-trione

54. Cortisone-21-acetate

55. 21-acetoxy-17,alpha-hydroxy-3,11,20-triketopregnene-4

56. 21-acetoxy-17,alpha-hydroxypregn-4-ene-3,11,20-trione

57. Cortone Acetate (tn)

58. 4-pregnene-17,alpha,21-diol-3,11,20-trione 21-acetate

59. Schembl4501

60. Chembl1650

61. Lopac0_000271

62. Mls000069478

63. Mls002207136

64. Mls002548859

65. 21-acetoxy-4-pregnen-17alpha-ol-3,11,20-trione

66. Cortisone Acetate [jan]

67. Cortisone Acetate (jp17/usp)

68. Dtxsid0022858

69. Cortisone 21-acetate, >=99%

70. Cortisone Acetate [vandf]

71. Cortisone Aceticum [hpus]

72. Cortisone Acetate [mart.]

73. 17alpha,21-dihydroxy-4-pregnene-3,11,20-trione 21-acetate

74. Hms2235d24

75. Hms3259n19

76. Hms3260h04

77. Cortisone Acetate [usp-rs]

78. Cortisone Acetate [who-dd]

79. Bcp08487

80. Cortisone 21-acetate [mi]

81. Nsc49420

82. Zinc3875334

83. Tox21_113482

84. Tox21_500271

85. Bdbm50455157

86. Hy-17461a

87. Lmst02030120

88. Akos005267225

89. Tox21_113482_1

90. Ac-6827

91. Ccg-204366

92. Cortisone Acetate [orange Book]

93. Cs-1742

94. Db01380

95. Lp00271

96. Nc00677

97. Sdccgsbi-0050259.p002

98. Cortisone Acetate [ep Monograph]

99. Cortisone Acetate [usp Monograph]

100. Ncgc00021191-03

101. Ncgc00021191-06

102. Ncgc00021191-08

103. Ncgc00021191-09

104. Ncgc00021191-16

105. Ncgc00260956-01

106. [2-[(8s,9s,10r,13s,14s,17r)-17-hydroxy-10,13-dimethyl-3,11-dioxo-1,2,6,7,8,9,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] Acetate

107. 2-((1s,10s,11s,15s,2r,14r)-14-hydroxy-2,15-dimethyl-5,17-dioxotetracyclo[8.7.0 .0<2,7>.0<11,15>]heptadec-6-en-14-yl)-2-oxoethyl Acetate

108. As-13692

109. Cortisone Acetate 100 Microg/ml In Methanol

110. Eu-0100271

111. S2559

112. C08173

113. C90609

114. D00973

115. Ab00384283-08

116. Ab00384283_09

117. Cortisone Acetate 100 Microg/ml In Acetonitrile

118. 003c609

119. W-105993

120. Brd-k86161929-001-13-3

121. Hydrocortisone Acetate Impurity D [ep Impurity]

122. Pregn-4-ene-3,20-trione, 21-(acetyloxy)-17-hydroxy-

123. 17-hydroxy-3,11,20-trioxopregn-4-en-21-yl Acetate #

124. 21-acetoxy-17.alpha.-hydroxy-3,11,20-triketopregnene-4

125. 21-acetoxy-17.alpha.-hydroxypregn-4-ene-3,11,20-trione

126. 4-pregnen-17.alpha.,21-diol-3,11,20-trione 21-acetate

127. Pregn-4-ene-3,20-trione, 17,21-dihydroxy-, 21-acetate

128. 4-pregnene-17.alpha.,21-diol-3,11,20-trione 21-acetate

129. Cortisone Acetate, European Pharmacopoeia (ep) Reference Standard

130. Cortisone Acetate, United States Pharmacopeia (usp) Reference Standard

131. Cortisone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 402.5 g/mol
Molecular Formula C23H30O6
XLogP32.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass402.20423867 g/mol
Monoisotopic Mass402.20423867 g/mol
Topological Polar Surface Area97.7 Ų
Heavy Atom Count29
Formal Charge0
Complexity827
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameCortisone acetate
PubMed HealthCortisone Acetate (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Immune Suppressant
Drug LabelGlucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.Cortisone acetate is a white or practically white, odorless, crystalline powder. It is stable in air. It i...
Active IngredientCortisone acetate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyHikma Pharms

2 of 2  
Drug NameCortisone acetate
PubMed HealthCortisone Acetate (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Immune Suppressant
Drug LabelGlucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.Cortisone acetate is a white or practically white, odorless, crystalline powder. It is stable in air. It i...
Active IngredientCortisone acetate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyHikma Pharms

4.2 Drug Indication

Cortisone acetate is indicated to treat a wide variety of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, and gastrointestinal diseases and disorders.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. The duration of action is moderate as it is generally given once daily. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.


5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 Absorption, Distribution and Excretion

Route of Elimination

Corticosteroids are eliminated predominantly in the urine.


Clearance

Data regarding the clearance of cortisone acetate is not readily available.


5.5 Mechanism of Action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.


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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"HYDROCORTISONE ACETATE PH.EUR9.8 MICRO HYDROCORTISONE ACETATE PH.EUR9.8 MICRO","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"TIANJIN JINJIN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"820","totalValueFC":"49401.7","currency":"USD","unitRateINR":"70151","date":"14-May-2025","totalValueINR":"4209060","totalValueInUsd":"49401.7","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"2045294","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Micronized","supplierPort":"BEIJING","supplierAddress":"CO.,LTD NO 8 OF JINGFU ROAD, INDUSTRIAL ZONE OF ZHANGJIAWO TOWN, XIDING CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747333800,"product":"HYDROCORTISONE HYDROCORTISONE","address":"PLOT NO.2516 2518,","city":"DIST: VALSAD\/GUJARAT","supplier":"HIGH HOPE PBC HK COLIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ARIHANTANAM LIFECARE PRIVATE LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"180","totalValueFC":"36506.8","currency":"USD","unitRateINR":"15552","date":"16-May-2025","totalValueINR":"3110400","totalValueInUsd":"36506.8","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"2081784","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"UNIT 106 ON 1\/F,WAYSON COMMERCIAL BUILDING,28 CONNAUGHT ROAD WEST, SHEUNG WAN HONG KONG","customerAddress":"PLOT NO.2516 2518,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747420200,"product":"HYDROCORTISONE (NOT FOR MEDICINAL USE) HYDROCORTISONE (NOT FOR MEDICINAL USE)","address":"B 1 \/1 JUNA B TYPE,NEAR GIDC GARDE","city":"VAPI,GUJARAT","supplier":"ZHEJIANG SACHEM PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"YAARI HEALTHCARE LLP","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"207","totalValueFC":"8396.6","currency":"USD","unitRateINR":"17884.8","date":"17-May-2025","totalValueINR":"715392","totalValueInUsd":"8396.6","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"2109260","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"TECHNOLOGY CO., LTD ROOM1611,BUILDI NG7, CANAL FORTUNE CENTER, NO.99 SH ENHUA ROAD,GONGSHU DISTRICT,HANGZHO China","customerAddress":"B 1 \/1 JUNA B TYPE,NEAR GIDC GARDE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747593000,"product":"HYDROCORTISONE USP(LICENSE NO-SW\/OD\/11\/2025\/0000010713) HYDROCORTISONE USP(LICENSE NO-SW\/OD\/11\/2025\/0000010713)","address":"S.No.258,Thiruvandavar Village","city":"Kancheepuram District","supplier":"DARSHENG TRADE TECH DEVELOPMENT CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"HIBROW HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"520","totalValueFC":"6327.8","currency":"USD","unitRateINR":"44928","date":"19-May-2025","totalValueINR":"539136","totalValueInUsd":"6327.8","indian_port":"Madras Air","hs_no":"29372100","bill_no":"2138401","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"51 JFK PARKWAY FIRST FLOOR WEST, SH ORT HILLS, NJ07078 SDNF United States","customerAddress":"S.No.258,Thiruvandavar Village"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748457000,"product":"HYDROCORTISONE IP\/EP\/USP MICRONIZED(CAS NO.50-23-7) HYDROCORTISONE IP\/EP\/USP MICRONIZED(CAS NO.50-23-7)","address":"3RD FLOOR, 304, TOWN CENTRE","city":"MUMBAI","supplier":"TIANJIN JINJIN PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"VANQUEST PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"178","totalValueFC":"72202.3","currency":"USD","unitRateINR":"15379.2","date":"29-May-2025","totalValueINR":"6151680","totalValueInUsd":"72202.3","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"2358282","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Micronized","supplierPort":"BEIJING","supplierAddress":"NO.8 OF JINGFU ROAD, INDUSTRIAL ZON E OF ZHANGJIAWO TOWN, XIQING DISTRI CT,TIANJIN,CHINA Tianjin, , China China","customerAddress":"3RD FLOOR, 304, TOWN CENTRE"}]
05-Jan-2022
30-May-2025
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ABOUT THIS PAGE

Looking for 50-04-4 / Cortisone API manufacturers, exporters & distributors?

Cortisone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cortisone 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 Cortisone manufacturer or Cortisone supplier for your needs.

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

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

API | Excipient name

Cortisone

Synonyms

Cortisone 21-acetate, 50-04-4, Cortone acetate, Incortin, Biocort acetate, Artriona

Cas Number

50-04-4

Unique Ingredient Identifier (UNII)

883WKN7W8X

About Cortisone

A naturally occurring glucocorticoid that has been used in replacement therapy for ADRENAL INSUFFICIENCY and as an anti-inflammatory agent. Cortisone itself is inactive; it is converted in the liver to the active metabolite HYDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p726)

CORTONE Manufacturers

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

CORTONE Suppliers

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

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

CORTONE USDMF

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

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

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

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

CORTONE CEP

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

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

CORTONE 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 CORTONE as an active pharmaceutical ingredient (API).

Finished drug products

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

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

CORTONE GMP

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

CORTONE CoA

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

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

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