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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

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USP

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JP

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Europe

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MARKET PLACE

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Chemistry

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Also known as: 1629229-37-3, Esn364, Esn-364, Fezolinetant [usan], 83vne45kxx, A2693
Molecular Formula
C16H15FN6OS
Molecular Weight
358.4  g/mol
InChI Key
PPSNFPASKFYPMN-SECBINFHSA-N
FDA UNII
83VNE45KXX

Fezolinetant
Fezolinetant is under investigation in clinical trial NCT04234204 (A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause).
1 2D Structure

Fezolinetant

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4-fluorophenyl)-[(8R)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]methanone
2.1.2 InChI
InChI=1S/C16H15FN6OS/c1-9-13-19-20-14(15-18-10(2)21-25-15)23(13)8-7-22(9)16(24)11-3-5-12(17)6-4-11/h3-6,9H,7-8H2,1-2H3/t9-/m1/s1
2.1.3 InChI Key
PPSNFPASKFYPMN-SECBINFHSA-N
2.1.4 Canonical SMILES
CC1C2=NN=C(N2CCN1C(=O)C3=CC=C(C=C3)F)C4=NC(=NS4)C
2.1.5 Isomeric SMILES
C[C@@H]1C2=NN=C(N2CCN1C(=O)C3=CC=C(C=C3)F)C4=NC(=NS4)C
2.2 Other Identifiers
2.2.1 UNII
83VNE45KXX
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Esn364

2.3.2 Depositor-Supplied Synonyms

1. 1629229-37-3

2. Esn364

3. Esn-364

4. Fezolinetant [usan]

5. 83vne45kxx

6. A2693

7. Chembl3608680

8. As3472693-00

9. (4-fluorophenyl)-[(8r)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]methanone

10. Es-256364

11. A-2693

12. As-3472693-00

13. (r)-(4-fluorophenyl)(8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl)methanone

14. Methanone, ((8r)-5,6-dihydro-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-1,2,4-triazolo(4,3-a)pyrazin-7(8h)-yl)(4-fluorophenyl)-

15. Fezolinetant [inn]

16. Unii-83vne45kxx

17. Fezolinetant [who-dd]

18. Schembl16114810

19. Gtpl10422

20. Esn-364esn-364

21. Dtxsid601103615

22. Ex-a6226

23. Bdbm50112244

24. Who 10205

25. Compound 3 [pmid:26191358]

26. Cs-7952

27. Ac-36697

28. Hy-19632

29. D87169

30. Q27269455

31. ((8r)-5,6-dihydro-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-1,2,4-triazolo(4,3-a)pyrazin-7(8h)-yl)(4-fluorophenyl)methanone

32. (4-fluorophenyl)((8r)-5,6-dihydro-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)methanone

33. (4-fluorophenyl)((8r)-8-methyl-3-(3-methyl-1,2,4- Thiadiazol-5-yl)-5,6-dihydro-1,2,4-triazolo(4,3-a)pyrazin- 7(8h)-yl)methanone

2.4 Create Date
2016-02-23
3 Chemical and Physical Properties
Molecular Weight 358.4 g/mol
Molecular Formula C16H15FN6OS
XLogP31.6
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count2
Exact Mass358.10120846 g/mol
Monoisotopic Mass358.10120846 g/mol
Topological Polar Surface Area105 Ų
Heavy Atom Count25
Formal Charge0
Complexity505
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Moehs Iberica

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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02

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Neuland

03

Mankind Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

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Ami Lifesciences Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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AMI Lifesciences

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Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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HRV Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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  • EDQM
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Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

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Beijing Sjar Technology Developmen...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hebi Xinhe Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Coatings Trends
Not Confirmed
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Hebi Xinhe Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Drugs in Development

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01

Shehzad Basaria, M.D.

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ESCRS
Not Confirmed

Shehzad Basaria, M.D.

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ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 04, 2025

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02

Yale University

Country
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ESCRS
Not Confirmed

Yale University

Country
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ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 08, 2025

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03

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 06, 2025

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Details:

Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist being investigated for the treatment of vasomotor symptoms in patients with breast cancer.


Lead Product(s): Fezolinetant,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 27, 2024

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04

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist being investigated for the treatment of vasomotor symptoms in patients with breast cancer.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 27, 2024

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05

ESCRS
Not Confirmed

Details:

Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.


Lead Product(s): Fezolinetant,Inapplicable

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 03, 2024

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06

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 03, 2024

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07

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 16, 2024

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08

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 16, 2024

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Details:

Veoza (fezolinetant), an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.


Lead Product(s): Fezolinetant,Inapplicable

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 13, 2023

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09

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Veoza (fezolinetant), an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 13, 2023

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Details:

Veozah (fezolinetant) works by blocking NKB binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the hypothalamus to reduce the frequency and severity of moderate to severe VMS due to menopause.


Lead Product(s): Fezolinetant,Inapplicable

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 12, 2023

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10

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : Veozah (fezolinetant) works by blocking NKB binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the hypothalamus to reduce the frequency and severity of moderate to severe VMS due to menopause.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 12, 2023

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INTERMEDIATE SUPPLIERS

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 1375066-73-1

End Use API : Fezolinetant

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 922178-61-8

End Use API : Fezolinetant

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

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03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 76162-56-6

End Use API : Fezolinetant

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

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04

ESCRS
Not Confirmed
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ESCRS
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CAS Number : 17452-74-3

End Use API : Fezolinetant

About The Company : Cubane Pharmaceuticals is a science-led company engaged in the manufacturing of Pharmaceutical intermediates. Led by zealous youth, we are building on a 50-year...

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ESCRS
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ESCRS
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CAS Number : 2757-23-5

End Use API : Fezolinetant

About The Company : Cubane Pharmaceuticals is a science-led company engaged in the manufacturing of Pharmaceutical intermediates. Led by zealous youth, we are building on a 50-year...

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06

ESCRS
Not Confirmed
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ESCRS
Not Confirmed
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CAS Number : 1375066-73-1

End Use API : Fezolinetant

About The Company : Cubane Pharmaceuticals is a science-led company engaged in the manufacturing of Pharmaceutical intermediates. Led by zealous youth, we are building on a 50-year...

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FDF Dossiers

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01

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FEZOLINETANT

Brand Name : VEOZAH

Dosage Form : TABLET;ORAL

Dosage Strength : 45MG

Packaging :

Approval Date : 2023-05-12

Application Number : 216578

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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01

ASTELLAS

Japan
ESCRS
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ASTELLAS

Japan
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ESCRS
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FEZOLINETANT

Brand Name : VEOZAH

Dosage Form : TABLET;ORAL

Dosage Strength : 45MG

Approval Date : 2023-05-12

Application Number : 216578

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Patents & EXCLUSIVITIES

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US Patents

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01

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ASTELLAS

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FEZOLINETANT

US Patent Number : 8871761

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216578

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-04-04

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02

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ASTELLAS

Japan
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ESCRS
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FEZOLINETANT

US Patent Number : 9422299

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216578

Patent Use Code : U-3622

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-03-28

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03

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ESCRS
Not Confirmed

ASTELLAS

Japan
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ESCRS
Not Confirmed

FEZOLINETANT

US Patent Number : 9987274

Drug Substance Claim :

Drug Product Claim :

Application Number : 216578

Patent Use Code : U-3622

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-03-28

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04

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ESCRS
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ASTELLAS

Japan
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ESCRS
Not Confirmed

FEZOLINETANT

US Patent Number : 10836768

Drug Substance Claim :

Drug Product Claim :

Application Number : 216578

Patent Use Code : U-3621

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-03-28

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ABOUT THIS PAGE

Looking for 1629229-37-3 / Fezolinetant API manufacturers, exporters & distributors?

Fezolinetant manufacturers, exporters & distributors 1

17

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

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

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

API | Excipient name

Fezolinetant

Synonyms

1629229-37-3, Esn364, Esn-364, Fezolinetant [usan], 83vne45kxx, A2693

Cas Number

1629229-37-3

Unique Ingredient Identifier (UNII)

83VNE45KXX

About Fezolinetant

Fezolinetant is under investigation in clinical trial NCT04234204 (A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause).

Fezolinetant Manufacturers

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

Fezolinetant Suppliers

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

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

Fezolinetant USDMF

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

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

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

Fezolinetant 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 Fezolinetant as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fezolinetant GMP

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

Fezolinetant CoA

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

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

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