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Chemistry

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Also known as: 286930-03-8, Toviaz, (r)-fesoterodine fumarate, Spm 907, Spm 8272, Spm-907
Molecular Formula
C30H41NO7
Molecular Weight
527.6  g/mol
InChI Key
MWHXMIASLKXGBU-RNCYCKTQSA-N
FDA UNII
EOS72165S7

Fesoterodine
Fesoterodine Fumarate is the fumarate salt form of fesoterodine, a competitive muscarinic receptor antagonist with muscle relaxant and urinary antispasmodic properties. Fesoterodine is rapidly hydrolyzed in vivo into its active metabolite 5-hydroxy methyl tolterodine, which binds and inhibits muscarinic receptors on the bladder detrusor muscle, thereby preventing bladder contractions or spasms caused by acetylcholine. This results in the relaxation of bladder smooth muscle and greater bladder capacity, in addition to a reduction in involuntary muscle contractions and involuntary loss of urine. The active metabolite does not interact with alpha-adrenergic, serotonergic, histaminergic and excitatory amino acid receptors and is eliminated via renal excretion.
1 2D Structure

Fesoterodine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate
2.1.2 InChI
InChI=1S/C26H37NO3.C4H4O4/c1-18(2)26(29)30-25-13-12-21(17-28)16-24(25)23(22-10-8-7-9-11-22)14-15-27(19(3)4)20(5)6;5-3(6)1-2-4(7)8/h7-13,16,18-20,23,28H,14-15,17H2,1-6H3;1-2H,(H,5,6)(H,7,8)/b;2-1+/t23-;/m1./s1
2.1.3 InChI Key
MWHXMIASLKXGBU-RNCYCKTQSA-N
2.1.4 Canonical SMILES
CC(C)C(=O)OC1=C(C=C(C=C1)CO)C(CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC(C)C(=O)OC1=C(C=C(C=C1)CO)[C@H](CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
EOS72165S7
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fesoterodine

2. Toviaz

2.3.2 Depositor-Supplied Synonyms

1. 286930-03-8

2. Toviaz

3. (r)-fesoterodine Fumarate

4. Spm 907

5. Spm 8272

6. Spm-907

7. Spm-8272

8. Fesoterodine Maleate

9. Fesoterodine (fumarate)

10. Eos72165s7

11. (e)-but-2-enedioic Acid;[2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

12. Propanoic Acid, 2-methyl-, 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester, (2e)-2-butenedioate (1:1)

13. 286930-03-8 (fumarate); 286930-02-7 (free Base)

14. Fesoterodine Fumarate [usan]

15. Unii-eos72165s7

16. Fesoterodine Fumarate [usan:jan]

17. (e)-but-2-enedioic Acid,[2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

18. Toviaz (tn)

19. (r)-fesoterodinefumarate

20. Mls003915638

21. Schembl814971

22. Fesoterodine Fumarate - Toviaz

23. Schembl1993632

24. Chembl1201765

25. Dtxsid00904655

26. Bcpp000231

27. Fesoterodine Fumarate (jan/usan)

28. Fesoterodine Fumarate [mi]

29. Hms3884d11

30. Fesoterodine Fumarate [jan]

31. Amy37611

32. Hy-a0030

33. Bdbm50248002

34. Fesoterodine Fumarate [vandf]

35. Mfcd12756004

36. S2240

37. Fesoterodine Fumarate [mart.]

38. Akos005146248

39. Akos015855886

40. Fesoterodine Fumarate [who-dd]

41. Ac-3486

42. Bcp9000682

43. Ccg-269901

44. Cs-0822

45. Ks-1298

46. 2-((1r)-3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Isobutyrate

47. Fesoterodine Fumarate [ema Epar]

48. 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate Hydrogen (2e)-butenedioate (salt)

49. Propanoic Acid, 2-methyl-, 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Ester, (2e)-2-butenedioate (1:1) (salt)

50. Smr002544691

51. Fesoterodine Fumarate [orange Book]

52. Pf-00695838

53. D08923

54. 930f038

55. A846296

56. Q27277274

57. 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate Hydrogen(2e)-butenedioate (salt)

58. Fesoterodinefumarate;(r)-fesoterodine Fumarate;2-methylpropanoic Acid 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester (2e)-2-butenedioate

59. Propanoic Acid,2-methyl ,2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl Ester,(2e)-2-butenedioate (1:1)(salt)

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 527.6 g/mol
Molecular Formula C30H41NO7
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count13
Exact Mass527.28830265 g/mol
Monoisotopic Mass527.28830265 g/mol
Topological Polar Surface Area124 Ų
Heavy Atom Count38
Formal Charge0
Complexity610
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameToviaz
PubMed HealthFesoterodine (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelToviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a musca...
Active IngredientFesoterodine fumarate
Dosage FormTablet, extended release
RouteOral
Strength8mg; 4mg
Market StatusPrescription
CompanyPfizer

2 of 2  
Drug NameToviaz
PubMed HealthFesoterodine (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelToviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a musca...
Active IngredientFesoterodine fumarate
Dosage FormTablet, extended release
RouteOral
Strength8mg; 4mg
Market StatusPrescription
CompanyPfizer

4.2 Drug Indication

Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)


Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)


5.2 ATC Code

G04BD11


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Hetero Drugs

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Fesoterodine Fumarate IH

Date of Issue : 2022-09-30

Valid Till : 2025-08-08

Written Confirmation Number : WC-0066

Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...

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Fesoterodine Fumarate IH

Date of Issue : 2022-07-11

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Fesoterodine fumarate

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2016-04-29

Registration Number : 4579-12-ND

Manufacturer Name : Alembic Pharmaceuticals Limi...

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Hetero Drugs

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Fesoterodine fumarate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2018-05-31

Registration Number : Su331-16-ND

Manufacturer Name : Hetero Drugs Limited

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Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2017-12-05

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Pfizer Inc

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Fesoterodine fumarate

Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

Registration Date : 2009-06-17

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FESOTERODINE FUMARATE

NDC Package Code : 66005-0035

Start Marketing Date : 2011-01-10

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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NDC Package Code : 66005-0035

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End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FESOTERODINE FUMARATE

NDC Package Code : 65977-0093

Start Marketing Date : 2008-10-31

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FESOTERODINE FUMARATE

NDC Package Code : 71666-005

Start Marketing Date : 2018-09-29

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

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FESOTERODINE

NDC Package Code : 50370-0047

Start Marketing Date : 2014-07-10

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FESOTERODINE FUMARATE

NDC Package Code : 50370-0031

Start Marketing Date : 2012-06-21

End Marketing Date : 2025-12-31

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FESOTERODINE FUMARATE

NDC Package Code : 47621-025

Start Marketing Date : 2012-08-16

End Marketing Date : 2025-12-31

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LGM Pharma

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Fesoterodine

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LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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HRV Pharma

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Fesoterodine

About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Pharma effectively promote projects and products. HRV Pharma represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Pharma has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Fesoterodine

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Fesoterodine

About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...

Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. At Aurore, we aim to push the boundaries to manufacture and deliver high quality products that can be relied upon by both customers and regulators. Our thrust on rapidly adding capabilities have led us to acquire, integrate and expand our reach across the geographies.
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05

World Drug Safety EU
Not Confirmed
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World Drug Safety EU
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Fesoterodine

About the Company : Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren no...

Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren now has 3 pharmaceutical R&D centers, 1 clinical R&D center, 4 API production bases and 1 preparation production base, forming an end-to-end CDMO service system that can provide customers with drug R&D and production. The development of high-end formulations is a major advantage of Fukangren. Among them, multiple platform projects such as sustained and controlled release formulations.
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06

World Drug Safety EU
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World Drug Safety EU
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fesoterodine fumarate

About the Company : Boryung Pharmaceutical, aiming at the best not the biggest, started from the pharmacy since 1957 and has put a strong presence in Korean market as one of TOP leading pharmaceutical...

Boryung Pharmaceutical, aiming at the best not the biggest, started from the pharmacy since 1957 and has put a strong presence in Korean market as one of TOP leading pharmaceutical companies. Boryung has invested continually on research and development and made continuous efforts to produce high-quality products. Lately by developing new drug of Fimasartan(new chemical entity by Boryung's technology) with its own R&D, Boryung is accelerating its R&D activity to become global health care company. Also, synthetic API's & oncology formulation are core competence and have been attractive to many customers in regulated & non-regulated markets.
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07

Dipharma

Italy
World Drug Safety EU
Not Confirmed
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Dipharma

Italy
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World Drug Safety EU
Not Confirmed

Fesoterodine Fumarate

About the Company : Dipharma is a leading European manufacturer of Active Pharmaceutical Ingredients that has been developing innovative and proprietary processes since 1949. We support our custome...

Dipharma is a leading European manufacturer of Active Pharmaceutical Ingredients that has been developing innovative and proprietary processes since 1949. We support our customers worldwide with a strong and well resourced R&D team, three cGMP facilities in Europe, and offer world-renowned expertise in handling hazardous chemical processes. Our customers can benefit from our broad portfolio of generic Active Pharmaceutical Ingredients and a wide range of advanced technologies available for custom synthesis. They can rely on the highest quality standards, but it does not stop there, they can count on our experience in innovation.
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08

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World Drug Safety EU
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Fesoterodine

About the Company : Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk...

Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk drugs and intermediates at competitive price. Our objective of providing the critical India advantage to both the innovator and generic pharmaceutical players in both domestic and international markets including the regulated markets.
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09

World Drug Safety EU
Not Confirmed
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World Drug Safety EU
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fesoterodine fumarate

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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10

Raks Pharma

India
World Drug Safety EU
Not Confirmed
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Raks Pharma

India
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Fesoterodine

About the Company : Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuti...

Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuticals Ingredients and their intermediates. Till date the company has invested around US $ 50M and has filed 23 US DMFs and 1 CEP with US and European Authority's respectively. The manufacturing facility is also approved by USFDA and WHO. We at Raks are dedicated to develop and manufacture active pharmaceutical ingredients and intermediates. We are committed to create value through intellectual property, quality systems and customer relation across the globe.
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API Reference Price

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Italy SDNF Italy","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743618600,"product":"FESOTERODINE FUMARATE MICRO FESOTERODINE FUMARATE MICRO","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"12.27","actualQuantity":"12.27","unit":"KGS","unitRateFc":"13202.7","totalValueFC":"165211.5","currency":"EURO","unitRateINR":"1152600","date":"03-Apr-2025","totalValueINR":"14142402","totalValueInUsd":"165211.5","indian_port":"Hyderabad Air","hs_no":"29225090","bill_no":"9267774","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Micronized","supplierPort":"MALTA","supplierAddress":"Via Bissone, 5 20021 Baranzate (MI) ? Italy SDNF Italy","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
08-Apr-2022
01-Jul-2025
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Drugs in Development

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Details:

Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Urology Brand Name: Fesoterodine Fumarate-Generic

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 07, 2022

Dr Reddy Company Banner

01

Lead Product(s) : Fesoterodine,Inapplicable

Therapeutic Area : Urology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.

Product Name : Fesoterodine Fumarate-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 07, 2022

Dr Reddy Company Banner

Details:

Alembic Fesoterodine Fumarate-Generic is therapeutically equivalent to Pfizer Fesoterodine Fumarate Extended-Release Tablets indicated for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency.


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Urology Brand Name: Fesoterodine Fumarate-Generic

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 02, 2022

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02

World Drug Safety EU
Not Confirmed
World Drug Safety EU
Not Confirmed

Details : Alembic Fesoterodine Fumarate-Generic is therapeutically equivalent to Pfizer Fesoterodine Fumarate Extended-Release Tablets indicated for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency.

Product Name : Fesoterodine Fumarate-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 02, 2022

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03

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 20, 2020

blank

04

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 01, 2020

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Urology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: Pfizer Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 10, 2019

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05

University of Pennsylvania

Country
arrow
World Drug Safety EU
Not Confirmed

University of Pennsylvania

Country
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 10, 2019

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Pfizer Inc | International Collaboration on Repair Discoveries | Vancouver Coastal Health

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 08, 2016

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06

University of British Columbia

Country
arrow
World Drug Safety EU
Not Confirmed

University of British Columbia

Country
arrow
World Drug Safety EU
Not Confirmed

Lead Product(s) : Fesoterodine,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Pfizer Inc | International Collaboration on Repair Discoveries | Vancouver Coastal Health

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 08, 2016

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Urology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Pfizer Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 25, 2015

blank

07

Stéphane Bolduc

Country
arrow
World Drug Safety EU
Not Confirmed

Stéphane Bolduc

Country
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 25, 2015

blank

08

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Pfizer Inc

U.S.A
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 17, 2015

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Fesoterodine,Inapplicable

Therapeutic Area: Urology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Pfizer Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 31, 2014

blank

09

Stéphane Bolduc

Country
arrow
World Drug Safety EU
Not Confirmed

Stéphane Bolduc

Country
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 31, 2014

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Fesoterodine,Oxybutynin

Therapeutic Area: Urology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Pfizer Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2014

blank

10

University of Alberta

Country
arrow
World Drug Safety EU
Not Confirmed

University of Alberta

Country
arrow
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 15, 2014

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INTERMEDIATE SUPPLIERS

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  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 156755-23-6

End Use API : Fesoterodine

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 156755-24-7

End Use API : Fesoterodine

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 156755-25-8

End Use API : Fesoterodine

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 156755-35-0

End Use API : Fesoterodine

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG

USFDA APPLICATION NUMBER - 22030

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG

USFDA APPLICATION NUMBER - 22030

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ABOUT THIS PAGE

Looking for 286930-03-8 / Fesoterodine API manufacturers, exporters & distributors?

Fesoterodine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fesoterodine

Synonyms

286930-03-8, Toviaz, (r)-fesoterodine fumarate, Spm 907, Spm 8272, Spm-907

Cas Number

286930-03-8

Unique Ingredient Identifier (UNII)

EOS72165S7

About Fesoterodine

Fesoterodine Fumarate is the fumarate salt form of fesoterodine, a competitive muscarinic receptor antagonist with muscle relaxant and urinary antispasmodic properties. Fesoterodine is rapidly hydrolyzed in vivo into its active metabolite 5-hydroxy methyl tolterodine, which binds and inhibits muscarinic receptors on the bladder detrusor muscle, thereby preventing bladder contractions or spasms caused by acetylcholine. This results in the relaxation of bladder smooth muscle and greater bladder capacity, in addition to a reduction in involuntary muscle contractions and involuntary loss of urine. The active metabolite does not interact with alpha-adrenergic, serotonergic, histaminergic and excitatory amino acid receptors and is eliminated via renal excretion.

Fesoterodine Fumarate Manufacturers

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

Fesoterodine Fumarate Suppliers

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

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

Fesoterodine Fumarate USDMF

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

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

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

Fesoterodine Fumarate KDMF

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

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

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

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

Fesoterodine Fumarate WC

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

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

Fesoterodine Fumarate 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 Fesoterodine Fumarate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fesoterodine Fumarate GMP

Fesoterodine Fumarate 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 Fesoterodine Fumarate 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 Fesoterodine Fumarate GMP manufacturer or Fesoterodine Fumarate GMP API supplier for your needs.

Fesoterodine Fumarate CoA

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

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

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