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Eplerenone

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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21 FDA Orange Book
144 Europe
6 Canada
16 Australia
3 South Africa
24 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

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TABLET;ORAL - 25MG
TABLET;ORAL - 50MG

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Synopsis

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144

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Chemistry

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Also known as: Epoxymexrenone, Inspra, 107724-20-9, Sc-66110, Selara, Epleremone

Molecular Formula

C₂₄H₃₀O₆

Molecular Weight

414.5 g/mol

InChI Key

JUKPWJGBANNWMW-VWBFHTRKSA-N

FDA UNII

6995V82D0B

A spironolactone derivative and selective ALDOSTERONE RECEPTOR antagonist that is used in the management of HYPERTENSION and CONGESTIVE HEART FAILURE, post-MYOCARDIAL INFARCTION.

Eplerenone is an Aldosterone Antagonist. The mechanism of action of eplerenone is as an Aldosterone Antagonist.

1 2D Structure

Eplerenone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

methyl (1R,2S,9R,10R,11S,14R,15S,17R)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate

2.1.2 InChI

InChI=1S/C24H30O6/c1-21-7-4-14(25)10-13(21)11-15(20(27)28-3)19-16-5-8-23(9-6-18(26)30-23)22(16,2)12-17-24(19,21)29-17/h10,15-17,19H,4-9,11-12H2,1-3H3/t15-,16+,17-,19+,21+,22+,23-,24-/m1/s1

2.1.3 InChI Key

JUKPWJGBANNWMW-VWBFHTRKSA-N

2.1.4 Canonical SMILES

CC12CCC(=O)C=C1CC(C3C24C(O4)CC5(C3CCC56CCC(=O)O6)C)C(=O)OC

2.1.5 Isomeric SMILES

C[C@]12CCC(=O)C=C1C[C@H]([C@@H]3[C@]24[C@H](O4)C[C@]5([C@H]3CC[C@@]56CCC(=O)O6)C)C(=O)OC

2.2 Other Identifiers

2.2.1 UNII

6995V82D0B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 9,11-epoxy-7-(methoxycarbonyl)-3-oxo-17-pregn-4-ene-21,17-carbolactone

2. Eplerenon

3. Inspra

2.3.2 Depositor-Supplied Synonyms

1. Epoxymexrenone

2. Inspra

3. 107724-20-9

4. Sc-66110

5. Selara

6. Epleremone

7. Cgp 30083

8. Cgp-30083

9. Chembl1095097

10. Chebi:31547

11. Sc-6611o

12. 6995v82d0b

13. Ncgc00159559-02

14. Dsstox_cid_26094

15. Dsstox_rid_81333

16. Dsstox_gsid_46094

17. (+)-eplerenone

18. Eplerenone [usan]

19. Methyl (1'r,2r,2's,9'r,10'r,11's,15's,17'r)-2',15'-dimethyl-5,5'-dioxo-18'-oxaspiro[oxolane-2,14'-pentacyclo[8.8.0.0^{1,17}.0^{2,7}.0^{11,15}]octadecan]-6'-ene-9'-carboxylate

20. Methyl (1'r,2s,2's,9'r,10'r,11's,15's,17'r)-2',15'-dimethyl-5,5'-dioxo-18'-oxaspiro[oxolane-2,14'-pentacyclo[8.8.0.0^{1,17}.0^{2,7}.0^{11,15}]octadecan]-6'-ene-9'-carboxylate

21. Inspra (tn)

22. Cas-107724-20-9

23. Hsdb 7522

24. Eplerenone [usan:inn:ban]

25. Unii-6995v82d0b

26. Eplerenone- Bio-x

27. Sc 6110

28. Eplerenone [mi]

29. Eplerenone [inn]

30. Eplerenone [jan]

31. Eplerenone [hsdb]

32. Eplerenone [vandf]

33. Eplerenone [mart.]

34. Eplerenone [usp-rs]

35. Eplerenone [who-dd]

36. Schembl21515

37. 9,11alpha-epoxy-17-hydroxy-3-oxo-17alpha-pregn-4-ene-7alpha,21-dicarboxylic Acid, Gamma-lactone, Methyl Ester

38. Gtpl2876

39. Dtxsid2046094

40. Eplerenone (jp17/usan/inn)

41. Eplerenone [orange Book]

42. Eplerenone, >=98% (hplc)

43. Eplerenone [ep Monograph]

44. Hms3413k08

45. Hms3677k08

46. Hy-b0251

47. Zinc3985982

48. Tox21_111746

49. Bdbm50318300

50. Mfcd05662207

51. S1707

52. Akos015962307

53. Tox21_111746_1

54. Ac-4213

55. Ccg-268820

56. Db00700

57. Ks-1406

58. 7alpha-methoxycarbonyl-3-oxo-9,11alpha-epoxy-17alpha-pregn-4-ene-21,17-carbolactone

59. Ncgc00159559-03

60. Be164415

61. Pregn-4-ene-7,21-dicarboxylic Acid, 9,11-epoxy-17-hydroxy-3-oxo-, Gamma-lactone, Methyl Ester, (7alpha,11alpha,17alpha)-

62. Spiro(cyclopenta(7,8)phenanthro(4b,5-b)oxirene-7(3h),2'(3'h)-furan)-10-carboxylic Acid, 2,4,4',4a,5',5a,6,6a,8,9,9a,9b,10,11-tetradecahydro-4a,6a-dimethyl-2,5'-dioxo-, Methyl Ester, (4as,4br,5ar,6as,7 R,9as,9br,10r)-

63. E0905

64. D01115

65. Ab01274707-01

66. Ab01274707_02

67. A895400

68. Q423804

69. Sr-01000942233

70. Sr-01000942233-1

71. Methyl Dimethyl-5'-dioxo-spiro[[?]-[?],2'-tetrahydrofuran]carboxylate

72. (7?,11?,17?)-9,11-epoxy-17-hydroxy-3-oxo-pregn-4-ene-7,21-dicarboxylic Acid ?-lactone Methyl Ester

73. 9,11.alpha.-epoxy-17-hydroxy-3-oxo-17.alpha.-pregn-4-ene-7.alpha.,21-dicarboxylic Acid, .gamma.-lactone, Methyl Ester

74. 9,11alpha-epoxy-17-hydroxy-3-oxo-17alpha-pregn-4-ene-7alpha,21-dicarboxylic Acid Gamma-lactone Methyl Ester

75. Pregn-4-ene-7,21-dicarboxylic Acid, 9,11-epoxy-17-hydroxy-3-oxo-, G-lactone, Methyl Ester, (7.alpha.,11.alpha.,17.alpha)-

76. Ynu

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₃₀O₆
Molecular Weight	414.5 g/mol
XLogP3	1.4
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	2
Exact Mass	414.20423867 g/mol
Monoisotopic Mass	414.20423867 g/mol
Topological Polar Surface Area	82.2 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	907
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Eplerenone
PubMed Health	Eplerenone (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, -lactone, methyl ester, (7,11,17...
Active Ingredient	Eplerenone
Dosage Form	Tablet
Route	Oral
Strength	25mg; 50mg
Market Status	Prescription
Company	Apotex; Sandoz

2 of 4
Drug Name	Inspra
PubMed Health	Eplerenone (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, -lactone, methyl ester, (7,11,17)-. Its em...
Active Ingredient	Eplerenone
Dosage Form	Tablet
Route	Oral
Strength	25mg; 50mg
Market Status	Prescription
Company	Gd Searle

3 of 4
Drug Name	Eplerenone
PubMed Health	Eplerenone (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, -lactone, methyl ester, (7,11,17...
Active Ingredient	Eplerenone
Dosage Form	Tablet
Route	Oral
Strength	25mg; 50mg
Market Status	Prescription
Company	Apotex; Sandoz

4 of 4
Drug Name	Inspra
PubMed Health	Eplerenone (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, -lactone, methyl ester, (7,11,17)-. Its em...
Active Ingredient	Eplerenone
Dosage Form	Tablet
Route	Oral
Strength	25mg; 50mg
Market Status	Prescription
Company	Gd Searle

4.2 Therapeutic Uses

Eplerenone is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive drugs. /Included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

Inspra is indicated to improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction less than or equal to 40%) and clinical evidence of congestive heart failure after an acute myocardial infarction.

Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2537

... Eplerenone should replace spironolactone as a natriuretic and antikaliuretic in heart failure and as add-on treatment in severe systolic cardiac insufficiency, and it is indicated after an acute myocardial infarction complicated by left ventricular dysfunction and heart failure. The finding that hypertension control with diuretic-based pharmacotherapy results in better prevention of heart failure than pressure reduction with other drugs makes it pertinent to investigate whether diuretics in general, and eplerenone in particular, should constitute part of the initial pharmacotherapy for heart failure when there is no overt fluid retention and independent of the etiology. ...

PMID:15733814 Reyes AJ et al; Eur J Intern Med 16 (1): 3-11 (2005)

4.3 Drug Warning

FDA Pregnancy Risk Category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1246

... When used for hypertension, the drug is contraindicated in patients with type 2 diabetes mellitus with microalbuminuria, serum creatinine concentrations exceeding 2 or 1.8 mg/dL in males or females, respectively, creatinine clearance less than 50 mL/minute, ... .

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1979

The most serious risk associated with eplerenone therapy is hyperkalemia (serum potassium greater than 5.5 mEq/L), which may cause serious, sometimes fatal, cardiac arrhythmias. Patients with impaired renal function or diabetes mellitus and patients receiving concurrent agents affecting the renin-angiotensin-aldosterone system (e.g., angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists) are at an increased risk for developing hyperkalemia. Eplerenone should be used with caution in patients with congestive heart failure following an acute myocardial infarction, who have renal impairment (i.e., serum creatinine concentrations exceeding 2 or 1.8 mg/dL in males or females, respectively, or creatinine clearance of 50 mL/minute or less) or those with diabetes mellitus (including those with proteinuria). Serum potassium concentrations should be monitored periodically in patients receiving eplerenone. Dosage reduction has been shown to decrease serum potassium concentrations.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1979

Adverse effects reported in 1% or more of patients receiving eplerenone for the management of hypertension are dizziness, fatigue, flu-like symptoms, cough, diarrhea, abdominal pain, hyperkalemia, decreased serum sodium concentrations, abnormal vaginal bleeding, gynecomastia, hypercholesterolemia, hypertriglyceridemia, mastodynia, or albuminuria.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1979

For more Drug Warnings (Complete) data for EPLERENONE (12 total), please visit the HSDB record page.

4.4 Drug Indication

For improvement of survival of stable patients with left ventricular systolic dysfunction (ejection fraction <40%) and clinical evidence of congestive heart failure after an acute myocardial infarction.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Eplerenone, an aldosterone receptor antagonist similar to spironolactone, has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. Eplerenone selectively binds to recombinant human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.

5.2 MeSH Pharmacological Classification

Mineralocorticoid Receptor Antagonists

Drugs that bind to and block the activation of MINERALOCORTICOID RECEPTORS by MINERALOCORTICOIDS such as ALDOSTERONE. (See all compounds classified as Mineralocorticoid Receptor Antagonists.)

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

EPLERENONE

5.3.2 FDA UNII

6995V82D0B

5.3.3 Pharmacological Classes

Aldosterone Antagonists [MoA]; Aldosterone Antagonist [EPC]

5.4 ATC Code

C03DA04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

C - Cardiovascular system

C03 - Diuretics

C03D - Aldosterone antagonists and other potassium-sparing agents

C03DA - Aldosterone antagonists

C03DA04 - Eplerenone

5.5 Absorption, Distribution and Excretion

Absorption

The absolute bioavailability of eplerenone is unknown.

Volume of Distribution

43 to 90 L

Clearance

Apparent plasma cl=10 L/hr

Apparent plasma clearance: approximately 10 L/hr. Less than 5% is recovered as unchanged drug in the urine and feces. Renal: 67%. Fecal: 32%.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

Mean peak plasma concentrations of eplerenone are reached approximately 1.5 hours following oral administration. The absolute bioavailability of eplerenone is unknown. Both peak plasma levels (Cmax) and area under the curve (AUC) are dose proportional for doses of 25 to 100 mg and less than proportional at doses above 100 mg. The plasma protein binding of eplerenone is about 50% and it is primarily bound to alpha 1-acid glycoproteins. The apparent volume of distribution at steady state ranged from 43 to 90 L. Eplerenone does not preferentially bind to red blood cells.

Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2536

Eplerenone is distributed into milk in rats; ... .

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1979

... Preclinical data show that eplerenone and/or metabolites are present in rat breast milk (0.85:1 [milk:plasma] AUC ratio) obtained after a single oral dose. Peak concentrations in plasma and milk were obtained from 0.5 to 1 hour after dosing.

Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2538

5.6 Metabolism/Metabolites

Eplerenone is metabolized primarily by CYP3A4, however, no active metabolites have been identified in human plasma.

Eplerenone metabolism is primarily mediated via CYP3A4. No active metabolites have been identified in human plasma.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

Eplerenone has known human metabolites that include 21-hydroxyeplerenone and 6beta-hydroxyeplerenone.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

4-6 hours

Elimination: 4 to 6 hours.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

5.8 Mechanism of Action

Eplerenone binds to the mineralocorticoid receptor and thereby blocks the binding of aldosterone (component of the renin-angiotensin-aldosterone-system, or RAAS). Aldosterone synthesis, which occurs primarily in the adrenal gland, is modulated by multiple factors, including angiotensin II and non-RAAS mediators such as adrenocorticotropic hormone (ACTH) and potassium. Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, blood vessels, and brain) tissues and increases blood pressure through induction of sodium reabsorption and possibly other mechanisms.

Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone, and androgen receptors.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

Eplerenone has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with the inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulation levels do not overcome the effect of eplerenone on blood pressure.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system (RAAS). Aldosterone synthesis, which occurs primarily in the adrenal gland, is modulated by multiple factors, including angiotensin II and non-RAAS mediators such as adrenocorticotropic hormone (ACTH) and potassium. Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, blood vessels, brain) tissues and increases blood pressure through induction of sodium resorption and possibly other mechanisms.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 1245

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ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"102.91","actualQuantity":"102.91","unit":"KGS","unitRateFc":"3250","totalValueFC":"338643.3","currency":"USD","unitRateINR":"275762.5","date":"04-Sep-2024","totalValueINR":"28378718.88","totalValueInUsd":"338643.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5419645","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO 28 3 FLOOR MAD RID,28050, SPAIN Madrid, , Spain SDNF Spain Spain","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"EPLERENONE PH. EUR. ( ZHEJ.TIAN.AURI.) (EU). BATCH NO. EPLB-240706FC01. MFG. JUL.2024 EXP. JUN.2027","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"AURISCO PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"2000","totalValueFC":"50655.6","currency":"USD","unitRateINR":"169800","date":"11-Sep-2024","totalValueINR":"4245000","totalValueInUsd":"50655.6","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"5538923","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BADU INDUSTRIAL ZONE, TIANTAL, ZHE JIANG PROVINCE 317200, P.R. CHINA , , CHINA CHINA","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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INTERMEDIATES SUPPLIERS

01

Aurisco Pharmaceutical Co.,Ltd

China

BIO Partnering at JPM

Not Confirmed

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FDF Dossiers

01

Cohance Lifesciences

India

BIO Partnering at JPM

Not Confirmed

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Eplerenone

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Cohance Lifesciences

India

BIO Partnering at JPM

Not Confirmed

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Eplerenone

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

04

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

05

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; Bisoprolol; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 5MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

06

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; Bisoprolol; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

07

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; Bisoprolol; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 5MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

08

Egis Pharmaceuticals PLC

Hungary

BIO Partnering at JPM

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Hungary

Virtual Booth

Digital Content

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Dapagliflozin; Bisoprolol; eplerenon

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU-CTD Dossier: Q4.2026

Registration Country : Hungary

Product Web Link

09

Alfred E Tiefenbacher GmbH

Germany

BIO Partnering at JPM

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Eplerenone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Alfred E Tiefenbacher GmbH

Germany

BIO Partnering at JPM

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Eplerenone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

Only 10 entries up to this point, click to access all

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FDA Orange Book

01

BRECKENRIDGE

U.S.A

BIO Partnering at JPM

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

RLD : No

TE Code : AB

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2018-09-14

Application Number : 208283

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

BRECKENRIDGE

U.S.A

BIO Partnering at JPM

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

RLD : No

TE Code : AB

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2018-09-14

Application Number : 208283

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

CHARTWELL RX

U.S.A

BIO Partnering at JPM

Not Confirmed

04

CHARTWELL RX

BIO Partnering at JPM

Not Confirmed

08

WESTMINSTER PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

09

WESTMINSTER PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

10

ADAPTIS

Country

BIO Partnering at JPM

Not Confirmed

Only 10 entries up to this point, click to access all

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Europe

01

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

BIO Partnering at JPM

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Eplerenone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

BIO Partnering at JPM

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Eplerenone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

ACCORD HEALTHCARE SLU

United Kingdom

Country

BIO Partnering at JPM

Not Confirmed

09

Country

BIO Partnering at JPM

Not Confirmed

10

Country

BIO Partnering at JPM

Not Confirmed

Only 10 entries up to this point, click to access all

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 21437

DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 21437

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Coating Systems & Additives

Controlled & Modified Release

Direct Compression

Granulation

Thickeners and Stabilizers

Co-Processed Excipients

Solubilizers

Lubricants & Glidants

Disintegrants & Superdisintegrants

Topical

Film Formers & Plasticizers

Parenteral

Taste Masking

Empty Capsules

API Stability Enhancers

Emulsifying Agents

Rheology Modifiers

Vegetarian Capsules

Coloring Agents

Chewable & Orodispersible Aids

Surfactant & Foaming Agents

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Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Annual Reports

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Market Place

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APIs

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FDF DOSSIERS

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

Others

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ANALYTICAL

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BioAnalytical Methods

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ABOUT THIS PAGE

Eplerenone Manufacturers

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

Eplerenone Suppliers

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

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

Eplerenone USDMF

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

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

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

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

Eplerenone CEP

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

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

Eplerenone WC

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

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

Eplerenone 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 Eplerenone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Eplerenone GMP

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

Eplerenone CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

18 API Suppliers

7 USDMF

10 CEP/COS

2 JDMF

3 EU WC

11 NDC API

11 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

214 FDF Dossiers

21 FDA Orange Book

144 Europe

6 Canada

16 Australia

3 South Africa

24 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG

TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

2 Seqens

2 DKSH

4 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

10 Corel Pharma Chem

5 DFE Pharma

1 Finar

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

30 Kerry

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

11 Roquette

12 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders

45 Coating Systems & Additives

26 Controlled & Modified Release

24 Direct Compression

18 Granulation

17 Thickeners and Stabilizers

16 Co-Processed Excipients

16 Solubilizers

15 Lubricants & Glidants

15 Disintegrants & Superdisintegrants

11 Topical

10 Film Formers & Plasticizers

8 Parenteral