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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 7 USDMF, 7 CEP/COS, 1 JDMF, 3 EU WC, 2 NDC API, 14 Listed Suppliers, $ API Reference Price

26 API Suppliers
7 USDMF
7 CEP/COS
1 JDMF
3 EU WC
2 NDC API
14 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

63 FDF Dossiers, 30 FDA Orange Book, 2 Europe, 4 Canada, 8 Australia, 1 South Africa, 18 Listed Dossiers

63 FDF Dossiers
30 FDA Orange Book
2 Europe
4 Canada
8 Australia
1 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/VIAL, INJECTABLE;INJECTION - EQ 250MG BASE/VIAL, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL

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INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
INJECTABLE;INJECTION - EQ 250MG BASE/VIAL
INJECTABLE;INJECTION - EQ 500MG BASE/VIAL

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1 Nanjing Well Pharmaceutical, 1 Actylis, 1 Finar

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Hydrocortisone Sodium Succinate

Synopsis

ACTIVE PHARMA INGREDIENTS

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US Patents

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Data Compilation #PharmaFlow

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GLOBAL SALES INFORMATION

US Medicaid (USD)

850,712

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Finished Drug Prices

4EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 125-04-2, A-hydrocort, Hydrocortisone 21-hemisuccinate sodium salt, Cortop, Solu-cortef, Arcocort

Molecular Formula

C₂₅H₃₃NaO₈

Molecular Weight

484.5 g/mol

InChI Key

HHZQLQREDATOBM-CODXZCKSSA-M

FDA UNII

50LQB69S1Z

Hydrocortisone Sodium Succinate is the sodium salt of hydrocortisone succinate with glucocorticoid property. Hydrocortisone sodium succinate is chemically similar to the endogenous hormone that stimulates anti-inflammatory and immunosuppressive activities, in addition to exhibiting minor mineralocorticoid effects. This agent binds to intracellular glucocorticoid receptors and is translocated into the nucleus, where it initiates the transcription of glucocorticoid-responsive genes, such as various cytokines and lipocortins. Lipocortins inhibit phospholipase A2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes, both potent mediators of inflammation.

1 2D Structure

Hydrocortisone Sodium Succinate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;4-[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethoxy]-4-oxobutanoate

2.1.2 InChI

InChI=1S/C25H34O8.Na/c1-23-9-7-15(26)11-14(23)3-4-16-17-8-10-25(32,24(17,2)12-18(27)22(16)23)19(28)13-33-21(31)6-5-20(29)30;/h11,16-18,22,27,32H,3-10,12-13H2,1-2H3,(H,29,30);/q;+1/p-1/t16-,17-,18-,22+,23-,24-,25-;/m0./s1

2.1.3 InChI Key

HHZQLQREDATOBM-CODXZCKSSA-M

2.1.4 Canonical SMILES

CC12CCC(=O)C=C1CCC3C2C(CC4(C3CCC4(C(=O)COC(=O)CCC(=O)[O-])O)C)O.[Na+]

2.1.5 Isomeric SMILES

C[C@]12CCC(=O)C=C1CC[C@@H]3[C@@H]2[C@H](C[C@]4([C@H]3CC[C@@]4(C(=O)COC(=O)CCC(=O)[O-])O)C)O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

50LQB69S1Z

2.3 Synonyms

2.3.1 MeSH Synonyms

1. A-hyrocort

2. Cortisol Hemisuccinate

3. Cortisol Succinate

4. Cortisol Succinate, Sodium Salt

5. Cortisol-21-(hydrogen Succinate)

6. Hydrocortisone 21-sodium Succinate

7. Hydrocortisone Hemisuccinate

8. Hydrocortisone Hemisuccinate Anhydrous

9. Hydrocortisone Succinate

10. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, (11beta)-

11. Solu-cortef

12. Sopolcort H

13. Sopolkort

2.3.2 Depositor-Supplied Synonyms

1. 125-04-2

2. A-hydrocort

3. Hydrocortisone 21-hemisuccinate Sodium Salt

4. Cortop

5. Solu-cortef

6. Arcocort

7. Buccalsone

8. Corlan

9. Emi-corlin

10. Cortisol 21-(sodium Succinate)

11. Flebocortid

12. Hycorace

13. Intracort

14. Nordicort

15. Oralsone

16. Solu-hizon

17. Solu-glyc

18. Hydrocortisone 21-sodium Succinate

19. Ef-cortelan Soluble

20. 50lqb69s1z

21. Chebi:5782

22. Cortisol Sodium Succinate

23. Hydrocortisone Hemisuccinate

24. Cortisol Sodium Hemisuccinate

25. Sodium Hydrocortisone Succinate

26. Cortisol Hemisuccinate Sodium Salt

27. Hydrocortisone Sodium Hemisuccinate

28. Hydrocortisone 21-sodium Succinide

29. Sodium Hydrocortisone 21-succinate

30. Nsc-9152

31. Hydrocortisone 21-hemisuccinate Sodium

32. Hydrocortisone Sodium 21-hemisuccinate

33. Sodium Hydrocortisone 21-hemisuccinate

34. Hydrocortisone Hemisuccinate Sodium Salt

35. Dsstox_cid_28932

36. Dsstox_rid_83198

37. Dsstox_gsid_49006

38. Hydrocortisone 21-succinate Sodium Salt

39. Sodium 17-hydroxycorticosterone 21-succinate

40. Hidrokortizon

41. U 4905

42. Nositrol

43. Rapicort

44. Lycortin-s

45. Cas-125-04-2

46. Sodium;4-[2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-oxoethoxy]-4-oxobutanoate

47. Flebocortid [inj.]

48. Hydro-adreson Aquosum

49. Ncgc00022248-03

50. Idrocortisone B. I. L.

51. Unii-50lqb69s1z

52. Hydrocortisone Succinate,sodium Salt

53. Einecs 204-725-5

54. A-hydrocort (tn)

55. Solu-cortef (tn)

56. Hydrocortisone 21-(sodium Succinate)

57. Mfcd00069472

58. Hydrocortisone-21-hemisuccinate Sodium

59. Hydrocortisone-21-hemisuccinate Sodium Salt

60. Cortisol 21-hemisuccinate Sodium Salt

61. Hydrocortisone Sodium Succinate [usp:ban:jan]

62. Schembl93508

63. Hydrocortisoni Natrii Succinas

64. Mls000069545

65. Chembl1200495

66. Dtxsid2049006

67. Cortisol 21-hemisuccinate Sodium

68. Hms2234h22

69. Succinic Acid Hydrocortisone Sodium

70. Tox21_113501

71. Akos024386298

72. Tox21_113501_1

73. Cortisol, Succinate, Sodium Salt

74. Ncgc00022248-04

75. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, Monosodium Salt, (11.beta.)-

76. Smr000058768

77. Eu-0100623

78. Hydrocortisone Sodium Succinate (jp17/usp)

79. Hydrocortisone Sodium Succinate [jan]

80. U4905

81. C08178

82. D00978

83. F20569

84. H 2270

85. Hydrocortisone Sodium Succinate [mart.]

86. Hydrocortisone Sodium Succinate [vandf]

87. Hydrocortisone 21-sodium Succinate [mi]

88. Hydrocortisone Sodium Succinate [who-dd]

89. Hydrocortisone Sodium Succinate [who-ip]

90. Cortisol, 21-(hydrogen Succinate), Monosodium Salt

91. Hydrocortisone Sodium Succinate [orange Book]

92. Hydrocortisone Sodium Succinate [usp Monograph]

93. Hydrocortisoni Natrii Succinas [who-ip Latin]

94. Q27106890

95. Hydrocortisone 21-hemisuccinate Sodium Salt, >=90% (hplc)

96. Hydrocortisone 21-hemisuccinate Sodium Salt, Powder, Bioreagent, Suitable For Cell Culture

97. (11beta)-21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxypregn-14-ene-3,20-dione, Monosodium Salt

98. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, Monosodium Salt, (11beta)-

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₃₃NaO₈
Molecular Weight	484.5 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	7
Exact Mass	484.20731229 g/mol
Monoisotopic Mass	484.20731229 g/mol
Topological Polar Surface Area	141 Å²
Heavy Atom Count	34
Formal Charge	0
Complexity	915
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	A-hydrocort
PubMed Health	Hydrocortisone (Injection)
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant
Active Ingredient	Hydrocortisone sodium succinate
Dosage Form	Injectable
Route	Injection
Strength	eq 100mg base/vial
Market Status	Prescription
Company	Hospira

2 of 4
Drug Name	Solu-cortef
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Drug Label	SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.100...
Active Ingredient	Hydrocortisone sodium succinate
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial; eq 250mg base/vial; eq 1gm base/vial; eq 100mg base/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

3 of 4
Drug Name	A-hydrocort
PubMed Health	Hydrocortisone (Injection)
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant
Active Ingredient	Hydrocortisone sodium succinate
Dosage Form	Injectable
Route	Injection
Strength	eq 100mg base/vial
Market Status	Prescription
Company	Hospira

4 of 4
Drug Name	Solu-cortef
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Drug Label	SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.100...
Active Ingredient	Hydrocortisone sodium succinate
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial; eq 250mg base/vial; eq 1gm base/vial; eq 100mg base/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents

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

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

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

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API Reference Price

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

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

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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

USFDA APPLICATION NUMBER - 9866

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DATA COMPILATION #PharmaFlow

Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?

Over 700 commonly used generic medicines were recommended for suspension by the European Medicines Agency (EMA) based on data integrity concerns, over clinical studies conducted at GVK Biosciences in Hyderabad, India.What will be the global fallout of the European decision? The European decision has impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The original recommendation of suspending some of the medicines made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization- CRO) by the French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site.” 1000 drugs reviewed// 700 rejectedWhile over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site, over 300 of them had sufficient supporting data available from other sources. As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation will now be sent to the European Commission for a legally binding decision, which will apply to Member States regardless of the decision taken in the interim period.The updated list of medicines for which, the CHMP (Committee for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies are given 12 months to submit additional data. The potential global impact of the European suspensions?The GVK Biosciences scandal is almost as severe in magnitude and impact, as the data falsification concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity violations, which bankrupted clinical research organization, Cetero Research/PRACS. Based on the Cetero findings in the United States, the EMA suspended seven drugs. Now it remains to be seen, how the FDA will handle the data integrity concerns found in Europe since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals. Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS case”.It’s clear for us that this is not the end of the story…