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Also known as: 1050477-31-0, Kerendia, Bay 94-8862, Bay94-8862, Finerenone (bay 94-8862), (4s)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide
Molecular Formula
C21H22N4O3
Molecular Weight
378.4  g/mol
InChI Key
BTBHLEZXCOBLCY-QGZVFWFLSA-N
FDA UNII
DE2O63YV8R

Finerenone
Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. Patients with kidney disease, would originally be given [spironolactone] or [eplerenone] to antagonize the mineraclocorticoid receptor. Spironolactone has low selectivity and affinity for the receptor; it dissociates quickly and can also have effects at the androgen, progesterone, and glucocorticoid receptors. Eplerenone is more selective and has longer lasting effects. More selective nonsteroidal mineralocorticoid antagonists such as [apararenone], [esaxerenone], and finerenone were later developed. So far, finerenone is the only nonsteroidal mineralocorticoid receptor antagonist to be FDA approved. Finerenone was granted FDA approval on 9 July 2021.
Finerenone is a Nonsteroidal Mineralocorticoid-Receptor Antagonist. The mechanism of action of finerenone is as a Mineralocorticoid Receptor Antagonist.
1 2D Structure

Finerenone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide
2.1.2 InChI
InChI=1S/C21H22N4O3/c1-5-28-21-18-17(14-7-6-13(9-22)8-15(14)27-4)16(20(23)26)12(3)25-19(18)11(2)10-24-21/h6-8,10,17,25H,5H2,1-4H3,(H2,23,26)/t17-/m1/s1
2.1.3 InChI Key
BTBHLEZXCOBLCY-QGZVFWFLSA-N
2.1.4 Canonical SMILES
CCOC1=NC=C(C2=C1C(C(=C(N2)C)C(=O)N)C3=C(C=C(C=C3)C#N)OC)C
2.1.5 Isomeric SMILES
CCOC1=NC=C(C2=C1[C@@H](C(=C(N2)C)C(=O)N)C3=C(C=C(C=C3)C#N)OC)C
2.2 Other Identifiers
2.2.1 UNII
DE2O63YV8R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bay 94-8862

2. Kerendia

2.3.2 Depositor-Supplied Synonyms

1. 1050477-31-0

2. Kerendia

3. Bay 94-8862

4. Bay94-8862

5. Finerenone (bay 94-8862)

6. (4s)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide

7. Bay-94-8862

8. De2o63yv8r

9. 1,6-naphthyridine-3-carboxamide, 4-(4-cyano-2-methoxyphenyl)-5-ethoxy-1,4-dihydro-2,8-dimethyl-, (4s)-

10. Finerenone [usan:inn]

11. Unii-de2o63yv8r

12. Finerenone [inn]

13. Finerenone [jan]

14. Finerenone [usan]

15. Finerenone [who-dd]

16. Finerenone (jan/usan/inn)

17. Gtpl8678

18. Schembl8157011

19. Finerenone [orange Book]

20. Amy9115

21. Dtxsid10146928

22. Bcp24177

23. Ex-a2845

24. Bay948862

25. Bay 948862

26. Bay-948862

27. Ac-30916

28. Hy-111372

29. Cs-0040097

30. J3.584.878i

31. D10633

32. F53302

33. Q21099046

34. Bay94-8862; Bay 94-8862; Bay-94-8862; Bay948862; Bay 948862; Bay-948862

2.4 Create Date
2012-09-10
3 Chemical and Physical Properties
Molecular Weight 378.4 g/mol
Molecular Formula C21H22N4O3
XLogP32.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass378.16919058 g/mol
Monoisotopic Mass378.16919058 g/mol
Topological Polar Surface Area110 Ų
Heavy Atom Count28
Formal Charge0
Complexity670
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Finerenone is indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus.


Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.


Treatment of chronic kidney disease


Treatment of heart failure


5 Pharmacology and Biochemistry
5.1 Pharmacology

Finerenone is a non-steroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. It has a moderate duration of action as it is taken once daily, and a wide therapeutic window as patients were given doses from 1.25 mg to 80 mg in clinical trials. Patients should be counselled regarding the risk of hyperkalemia.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
FINERENONE
5.2.2 FDA UNII
DE2O63YV8R
5.2.3 Pharmacological Classes
Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC]; Mineralocorticoid Receptor Antagonists [MoA]
5.3 ATC Code

C09


C - Cardiovascular system

C03 - Diuretics

C03D - Aldosterone antagonists and other potassium-sparing agents

C03DA - Aldosterone antagonists

C03DA05 - Finerenone


5.4 Absorption, Distribution and Excretion

Absorption

A 10 mg oral dose of finerenone reaches a Cmax of 351 g/L, with a Tmax of 1.5 hours, and an AUC of 2820 g\*h/L in plasma. The same dose of finerenone reaches a Cmax of 226 g/L, with a Tmax of 1.5 hours, and an AUC of 1840 g\*h/L in whole blood. Regular doses of 20 mg of finerenone reach a geometric mean steady state Cmax of 160 g/L with an AUC of 686 g\*h/L.


Route of Elimination

The majority of the dose recovered in urine was in the form of the M2, M3 (47.8%), and M4 metabolites; <1.3% of the dose recovered in the urine was as the unchanged parent compound. The majority of the dose recovered in the feces was as the M5 metabolite, with only 0.2% eliminated as the unchanged parent compound. The M1 metabolite made up <1.5% of the recovered dose in urine and feces. Finerenone is not expected to be metabolized by the intestinal microflora.


Volume of Distribution

The volume of distribution of finerenone as steady state is 52.6L.


Clearance

The systemic clearance of finerenone is approximately 25 L/h.


5.5 Metabolism/Metabolites

Finerenone is approximately 90% metabolized by CYP3A4, and 10% metabolized by CYP2C8. There is a minor contribution to metabolism by CYP1A1. Finerenone has no active metabolites. Finerenone is aromatized to the M1 metabolite by CYP3A4 and CYP2C8, which is further hydroxylated by CYP3A4 to the M2 metabolite, and finally oxidized bye CYP3A4 to the M3 metabolite. Alternatively, finerenone can undergo epoxidation and possibly hydrolysis by CYP3A4 and CYP2C8 to form the M4 metabolite, which is hydroxylated again by CYP3A4 to the M5 metabolite, and oxidized to the M8 metabolite. Finerenone can also be hydroxylated by CYP2C8 to the M7 metabolite, and further oxidized to the M9 metabolite. The M10 metabolite is formed by the demethylation, oxidation, and ring opening of finerenone. The M13 metabolite is formed through de-ethylation of finerenone by CYP1A1, and the M14 metabolite is formed through an undefined multi-step process involving CYP2C8 and CYP3A4.


5.6 Biological Half-Life

The half life of a 10 mg dose of finerenone in 4 healthy men was 17.4 hours in plasma and 12.3 hours in whole blood. The terminal half life of finerenone is approximately 2-3 hours.


5.7 Mechanism of Action

Finerenone is a non-steroidal selective mineralocorticoid receptor (MR) antagonist with no significant affinity or activity at androgen, progesterone, estrogen, and glucocorticoid receptors. Animal studies have shown that finerenone binding to the MR reduces inflammation and fibrosis, and phase 2 clinical trials showed a reduction in albuminuria. Aldosterone is a mineralocorticoid hormone involved in the regulation of blood pressure, sodium reabsorption, and potassium excretion. In 1943, agonism of the MR along with increased salt was shown to be associated with malignant hypertension, which could progress to inflammation and fibrosis of organs. Binding of aldosterone, an MR agonist, to the MR causes a conformational change, which dissociates the receptor from inactivating chaperone proteins. The active MR translocates to the nucleus along with a complex of other coactivators to induce transcription of a number of genes. Finerenone's binding to the MR prevents binding of MR coactivators, which in turn prevents pro-inflammatory and pro-fibrotic gene transcription. Clinical trial data shows that blocking the mineralocorticoid receptor reduces mortality and morbidity in patients with chronic severe congestive heart failure with an ejection fraction 35%. Patients taking finerenone developed new onset atrial fibrillation or flutter (AFF) with a hazard ratio of 0.71. Finerenone lowered the risk of first onset of kidney failure, a sustained eGFR decrease of 40%, or death from a renal cause to a hazard ratio of 0.82. Cardiovascular outcomes including cardiovascular death, nonfatal heart attacks, nonfatal strokes, and hospitalization for heart failure in patients taking finerenone had a hazard ratio of 0.86 in patients with a history of AFF and 0.85 in patients without a history of AFF.


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BILLION CTR 1 WAN G KWONG RD KOWLOON BAY KL, HONG KON G, CHINA China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"FINERENONE (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5-ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1,6 (QTY:1 KGS, VALUE:USD 7250)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"HONG KONG AURISCO TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7250","totalValueFC":"7321","currency":"USD","unitRateINR":"615162.5","date":"16-Oct-2024","totalValueINR":"615162.5","totalValueInUsd":"7321","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6143507","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM D 10\/F TOWER A BILLION CTR 1 WAN G KWONG RD KOWLOON BAY KL, HONG KON G, CHINA China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"FINERENONE (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5-ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1,6 (QTY:1 KG, VALUE:USD 7250)FINERENONE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"HONG KONG AURISCO TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7250","totalValueFC":"7349","currency":"USD","unitRateINR":"636550","date":"07-Mar-2025","totalValueINR":"636550","totalValueInUsd":"7349","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8758394","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM D 10\/F TOWER A BILLION CTR 1 WAN G KWONG RD KOWLOON BAY KL, HONG KON G, CHINA China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
25-Dec-2022
04-Apr-2025
KGS
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Number of Transactions

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

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 21962-45-8

End Use API : Finerenone

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 95306-64-2

End Use API : Finerenone

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 65193-87-5

End Use API : Finerenone

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 79055-62-2

End Use API : Finerenone

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

05

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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CAS Number : 95306-64-2

End Use API : Finerenone

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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06

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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CAS Number : 79055-62-2

End Use API : Finerenone

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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07

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
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CAS Number : 21962-45-8

End Use API : Finerenone

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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08

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed
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CAS Number : 65193-87-5

End Use API : Finerenone

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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FDF Dossiers

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01

Bayer AG

Germany
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Bayer AG

Germany
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Specialty & Agro Chemical
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FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-07-09

Application Number : 215341

Regulatory Info : RX

Registration Country : USA

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02

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
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FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2021-07-09

Application Number : 215341

Regulatory Info : RX

Registration Country : USA

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03

Bayer AG

Germany
Specialty & Agro Chemical
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Bayer AG

Germany
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Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
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Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
Not Confirmed

Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2531917

Regulatory Info :

Registration Country : Canada

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07

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2531925

Regulatory Info :

Registration Country : Canada

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08

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Kerendia

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Bayer AG

Germany
Specialty & Agro Chemical
Not Confirmed
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Bayer AG

Germany
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Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Kerendia

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

EP Pharma

Egypt
Specialty & Agro Chemical
Not Confirmed
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EP Pharma

Egypt
arrow
Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Ckdneo

Dosage Form : FC Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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FDA Orange Book

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01

BAYER HLTHCARE

Germany
Specialty & Agro Chemical
Not Confirmed
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BAYER HLTHCARE

Germany
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Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2021-07-09

Application Number : 215341

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

BAYER HLTHCARE

Germany
Specialty & Agro Chemical
Not Confirmed
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BAYER HLTHCARE

Germany
arrow
Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2021-07-09

Application Number : 215341

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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01

Specialty & Agro Chemical
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Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Finerenonum

Brand Name : Kerendia

Dosage Form : Filmtablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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BAYER INC

Germany
Specialty & Agro Chemical
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BAYER INC

Germany
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Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2531917

Regulatory Info :

Registration Country : Canada

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02

BAYER INC

Germany
Specialty & Agro Chemical
Not Confirmed
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BAYER INC

Germany
arrow
Specialty & Agro Chemical
Not Confirmed

FINERENONE

Brand Name : KERENDIA

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2531925

Regulatory Info :

Registration Country : Canada

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Australia

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01

Specialty & Agro Chemical
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Finerenone

Brand Name : Kerendia

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Kerendia

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Listed Dossiers

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01

EP Pharma

Egypt
Specialty & Agro Chemical
Not Confirmed
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EP Pharma

Egypt
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Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Ckdneo

Dosage Form : FC Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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01

EP Pharma

Egypt
Specialty & Agro Chemical
Not Confirmed
arrow

EP Pharma

Egypt
arrow
Specialty & Agro Chemical
Not Confirmed

Finerenone

Dosage : FC Tablet

Dosage Strength : 20MG

Brand Name : Ckdneo

Approval Date :

Application Number :

Registration Country : Egypt

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02

EP Pharma

Egypt
Specialty & Agro Chemical
Not Confirmed
arrow

EP Pharma

Egypt
arrow
Specialty & Agro Chemical
Not Confirmed

Finerenone

Brand Name : Ckdneo

Dosage Form : FC Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

blank

02

EP Pharma

Egypt
Specialty & Agro Chemical
Not Confirmed
arrow

EP Pharma

Egypt
arrow
Specialty & Agro Chemical
Not Confirmed

Finerenone

Dosage : FC Tablet

Dosage Strength : 10MG

Brand Name : Ckdneo

Approval Date :

Application Number :

Registration Country : Egypt

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APIs

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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Discovery Europe
Not Confirmed

BAYER HLTHCARE

Germany
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Discovery Europe
Not Confirmed

FINERENONE

US Patent Number : RE49826

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 215341

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-07-29

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02

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Discovery Europe
Not Confirmed

BAYER HLTHCARE

Germany
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Discovery Europe
Not Confirmed

FINERENONE

US Patent Number : 8436180

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 215341

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-12

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03

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Discovery Europe
Not Confirmed

BAYER HLTHCARE

Germany
arrow
Discovery Europe
Not Confirmed

FINERENONE

US Patent Number : RE49826

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 215341

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-07-29

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04

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Discovery Europe
Not Confirmed

BAYER HLTHCARE

Germany
arrow
Discovery Europe
Not Confirmed

FINERENONE

US Patent Number : 8436180

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 215341

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-12

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ABOUT THIS PAGE

Looking for 1050477-31-0 / Finerenone API manufacturers, exporters & distributors?

Finerenone manufacturers, exporters & distributors 1

52

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

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

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

API | Excipient name

Finerenone

Synonyms

1050477-31-0, Kerendia, Bay 94-8862, Bay94-8862, Finerenone (bay 94-8862), (4s)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide

Cas Number

1050477-31-0

Unique Ingredient Identifier (UNII)

DE2O63YV8R

About Finerenone

Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. Patients with kidney disease, would originally be given [spironolactone] or [eplerenone] to antagonize the mineraclocorticoid receptor. Spironolactone has low selectivity and affinity for the receptor; it dissociates quickly and can also have effects at the androgen, progesterone, and glucocorticoid receptors. Eplerenone is more selective and has longer lasting effects. More selective nonsteroidal mineralocorticoid antagonists such as [apararenone], [esaxerenone], and finerenone were later developed. So far, finerenone is the only nonsteroidal mineralocorticoid receptor antagonist to be FDA approved. Finerenone was granted FDA approval on 9 July 2021.

Finerenone Manufacturers

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

Finerenone Suppliers

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

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

Finerenone USDMF

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

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

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

Finerenone KDMF

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

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

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

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

Finerenone 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 Finerenone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Finerenone GMP

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

Finerenone CoA

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

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

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