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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

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MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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FDA (Orange Book)

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

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US Exclusivities

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Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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GLOBAL SALES INFORMATION

US Medicaid

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Chemistry

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Also known as: 848259-27-8, Pemafibrate [inn], (r)-k-13675, K-13675, (r)-, (r)-2-(3-((benzo[d]oxazol-2-yl(3-(4-methoxyphenoxy)propyl)amino)methyl)phenoxy)butanoic acid, Chembl247951
Molecular Formula
C28H30N2O6
Molecular Weight
490.5  g/mol
InChI Key
ZHKNLJLMDFQVHJ-RUZDIDTESA-N
FDA UNII
17VGG92R23

Pemafibrate
Pemafibrate is under investigation in clinical trial NCT03350165 (A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)).
1 2D Structure

Pemafibrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-[3-[[1,3-benzoxazol-2-yl-[3-(4-methoxyphenoxy)propyl]amino]methyl]phenoxy]butanoic acid
2.1.2 InChI
InChI=1S/C28H30N2O6/c1-3-25(27(31)32)35-23-9-6-8-20(18-23)19-30(28-29-24-10-4-5-11-26(24)36-28)16-7-17-34-22-14-12-21(33-2)13-15-22/h4-6,8-15,18,25H,3,7,16-17,19H2,1-2H3,(H,31,32)/t25-/m1/s1
2.1.3 InChI Key
ZHKNLJLMDFQVHJ-RUZDIDTESA-N
2.1.4 Canonical SMILES
CCC(C(=O)O)OC1=CC=CC(=C1)CN(CCCOC2=CC=C(C=C2)OC)C3=NC4=CC=CC=C4O3
2.1.5 Isomeric SMILES
CC[C@H](C(=O)O)OC1=CC=CC(=C1)CN(CCCOC2=CC=C(C=C2)OC)C3=NC4=CC=CC=C4O3
2.2 Other Identifiers
2.2.1 UNII
17VGG92R23
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (r)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) Butanoic Acid

2. K 13675

3. K-13675

4. K-13675-d11

5. K-13675-d7

6. K13675

2.3.2 Depositor-Supplied Synonyms

1. 848259-27-8

2. Pemafibrate [inn]

3. (r)-k-13675

4. K-13675, (r)-

5. (r)-2-(3-((benzo[d]oxazol-2-yl(3-(4-methoxyphenoxy)propyl)amino)methyl)phenoxy)butanoic Acid

6. Chembl247951

7. Cas#848259-27-8

8. 17vgg92r23

9. Pemafibrate (jan)

10. Pemafibrate [jan]

11. (2r)-2-[3-[[1,3-benzoxazol-2-yl-[3-(4-methoxyphenoxy)propyl]amino]methyl]phenoxy]butanoic Acid

12. (2~{r})-2-[3-[[1,3-benzoxazol-2-yl-[3-(4-methoxyphenoxy)propyl]amino]methyl]phenoxy]butanoic Acid

13. Unii-17vgg92r23

14. Parmodia (tn)

15. P7f

16. Pemafibrate [mi]

17. K-877

18. (r)-k 13675

19. Pemafibrate [who-dd]

20. Schembl2766188

21. Dtxsid00233891

22. Glxc-25532

23. Bcp20864

24. Ex-a1919

25. Yib25927

26. Bdbm50214899

27. Cs-6084

28. Db15212

29. Ac-36249

30. Hy-17618

31. D10711

32. A914970

33. (r)-k-13675(r)-k-13675

34. Q27251943

35. K-877; (r)-k 13675; Cs-2768

36. K-877; K877; K 877; (r)-k 13675; (r)-k13675; (r)k-13675

37. (r)-2-(3-((n-(benzoxazol-2-yl)-n-(3-(4-methoxyphenoxy)propyl)amino)methyl)phenoxy)butanoic Acid

38. (r)-2-[3-[n-(benzoxazol-2-yl)-n-(3-(4-methoxyphenoxy)propyl)aminomethyl]phenoxy]butyric Acid

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 490.5 g/mol
Molecular Formula C28H30N2O6
XLogP36.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count13
Exact Mass490.21038668 g/mol
Monoisotopic Mass490.21038668 g/mol
Topological Polar Surface Area94.3 Ų
Heavy Atom Count36
Formal Charge0
Complexity658
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

Prevention of cardiovascular events in patients with elevated triglycerides levels, Treatment of hypertriglyceridaemia


API SUPPLIERS

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01

Metrochem API Private Limited

India

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

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

02

Ami Lifesciences Private Limited

India

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

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

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AMI Lifesciences

03

Maithri Drugs

India

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

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04

Sichuan Renan Pharmaceutical

China

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

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05

Fujian South Pharmaceutical

China

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

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Listed Suppliers

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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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Pemafibrate

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 ...

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 BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Pemafibrate

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
AMI Lifesciences

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Pemafibrate

About the Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, ...

Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, Nanfang Pharmaceutical has grown into a major domestic manufacturer of anti-tumor raw materials and intermediates, and has expanded to non-anti-tumor drugs. Using the company's accumulated rich experience and first-class technology in plant extraction, the company's product line has been expanded to the field of plant-derived products.
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Pemafibrate

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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Pemafibrate

About the Company : Sichuan Renan Pharmaceutical Co., Ltd., founded in June 2013 with 325 acres and more than 1000 employees , located in Yuechi Pharmaceutical Industrial Park, Guangan city Sichuan pr...

Sichuan Renan Pharmaceutical Co., Ltd., founded in June 2013 with 325 acres and more than 1000 employees , located in Yuechi Pharmaceutical Industrial Park, Guangan city Sichuan province,China , is a wholly-owned subsidiary of Chengdu Brilliant Pharmaceutical Co., Ltd group. Renan Pharma is PMDA and EU approved , it is a high-tech innovative enterprise committed to the research & development, producing and sales of high-tech APIs and intermediates for global.
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FDF Dossiers

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Pemafibrate

Brand Name : Pemfibra

Dosage Form : Film Coated Tablet

Dosage Strength : 0.1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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Listed Dossiers

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Pemafibrate

Brand Name : Pemfibra

Dosage Form : Film Coated Tablet

Dosage Strength : 0.1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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Pemafibrate

Dosage : Film Coated Tablet

Dosage Strength : 0.1MG

Brand Name : Pemfibra

Approval Date :

Application Number :

Registration Country : Egypt

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ABOUT THIS PAGE

Pemafibrate Manufacturers

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

Pemafibrate Suppliers

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

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

Pemafibrate GMP

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

Pemafibrate CoA

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

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

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