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Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

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JDMF

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EDQM

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Europe

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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

USDMF

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40592

Submission : 2024-09-27

Status : Active

Type : II

Moehs Iberica
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NDC API

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FEZOLINETANT

NDC Package Code : 59361-004

Start Marketing Date : 2023-05-12

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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

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Fezolinetant

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
Moehs Iberica

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Fezolinetant

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Fezolinetant

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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

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Fezolinetant

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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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 Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
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Fezolinetant

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Fezolinetant

About the Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial...

Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial Park in Heshan District, Hebi City, the company spans 146,200 square meters, with a planned construction area of 80,300 square meters and a total investment of CNY 750 million. Our facilities include production plants, warehouses, office buildings, fire safety infrastructure, and waste treatment systems.
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Fezolinetant

About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...

Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical company in 1995. Today, we have 11,000 employees and are heading towards a turnover of INR 50000 million. Our vast network includes 50 C&F agents and 7500+ stockists. We provide a wide range of products – Antibiotic, Antifungal, NSAIDs, Gastrointestinal, Anthelmintic, Cardiovascular, Dermal, Erectile Dysfunction, and several other categories – across the nation.
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ABOUT THIS PAGE

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

Fezolinetant manufacturers, exporters & distributors 1

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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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