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24 API Suppliers, 3 USDMF, 1 EU WC, 1 KDMF, 3 NDC API, 23 Listed Suppliers, $ API Reference Price

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3 USDMF
1 EU WC
1 KDMF
3 NDC API
23 Listed Suppliers
$ API Reference Price

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ACTIVE PHARMA INGREDIENTS

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Also known as: Fg-4592, 808118-40-3, Fg4592, Roxadustat (fg-4592), Asp1517, N-[(4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl]glycine

Molecular Formula

C₁₉H₁₆N₂O₅

Molecular Weight

352.3 g/mol

InChI Key

YOZBGTLTNGAVFU-UHFFFAOYSA-N

FDA UNII

X3O30D9YMX

Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PHI, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.

1 2D Structure

Roxadustat

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[(4-hydroxy-1-methyl-7-phenoxyisoquinoline-3-carbonyl)amino]acetic acid

2.1.2 InChI

InChI=1S/C19H16N2O5/c1-11-15-9-13(26-12-5-3-2-4-6-12)7-8-14(15)18(24)17(21-11)19(25)20-10-16(22)23/h2-9,24H,10H2,1H3,(H,20,25)(H,22,23)

2.1.3 InChI Key

YOZBGTLTNGAVFU-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C2C=C(C=CC2=C(C(=N1)C(=O)NCC(=O)O)O)OC3=CC=CC=C3

2.2 Other Identifiers

2.2.1 UNII

X3O30D9YMX

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Fg-4592

2. Fg4592

2.3.2 Depositor-Supplied Synonyms

1. Fg-4592

2. 808118-40-3

3. Fg4592

4. Roxadustat (fg-4592)

5. Asp1517

6. N-[(4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl]glycine

7. Asp 1517

8. 2-[(4-hydroxy-1-methyl-7-phenoxyisoquinoline-3-carbonyl)amino]acetic Acid

9. Glycine, N-[(4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl]-

10. Asp-1517

11. X3o30d9ymx

12. Fg-4592 (asp1517)

13. Chembl2338329

14. Fg 4592

15. (4-hydroxy-1-methyl-7-phenoxyisoquinoline-3-carbonyl)glycine

16. (((4-hydroxy-1-methyl-7-phenoxyisoquinolin-3-yl)carbonyl)amino)acetic Acid

17. Evrenzo

18. 2-(4-hydroxy-1-methyl-7-phenoxyisoquinoline-3-carboxamido)acetic Acid

19. N-((4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl)glycine

20. N-[(4-hydroxy-1-methyl-7-phenoxyisoquinolin-3-yl)carbonyl]glycine

21. 2-[(1-methyl-4-oxidanyl-7-phenoxy-isoquinolin-3-yl)carbonylamino]ethanoic Acid

22. Roxadustat [usan:inn]

23. Unii-x3o30d9ymx

24. Roxadustatum

25. N-((4-hydroxy-1-methyl-7-phenoxyisoquinolin-3-yl)carbonyl)glycine

26. Glycine, N-((4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl)-

27. 8ho

28. Evrenzo (tn)

29. Fg-4592[roxadustat]

30. Roxadustat [inn]

31. Roxadustat [jan]

32. Roxadustat [usan]

33. Roxadustat(fg-4592)

34. Roxadustat [who-dd]

35. Mls006010023

36. Roxadustat (jan/usan/inn)

37. Schembl523705

38. Gtpl8454

39. Dtxsid60230644

40. Ex-a390

41. Chebi:132774

42. Bcpp000230

43. Hms3654m03

44. Amy16514

45. Bcp02523

46. Bdbm50431015

47. Fg-4592,asp1517

48. Mfcd20040519

49. S1007

50. Zinc71257465

51. Akos026674331

52. Bcp9000684

53. Ccg-268052

54. Cs-1094

55. Db04847

56. Sb16615

57. Ncgc00346527-01

58. Ncgc00346527-07

59. Ac-31003

60. As-17052

61. Hy-13426

62. Smr004701207

63. Db-075703

64. Sw219900-1

65. D10593

66. J-522733

67. Q27088611

68. 2-[[4-hydroxy-1-methyl-7-(phenoxy)isoquinoline-3-carbonyl]amino]acetic Acid

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₁₆N₂O₅
Molecular Weight	352.3 g/mol
XLogP3	3.4
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	352.10592162 g/mol
Monoisotopic Mass	352.10592162 g/mol
Topological Polar Surface Area	109 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	508
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

In clinical development for the treatment of anemia of chronic inflammatory disease.

Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

5 Pharmacology and Biochemistry

5.1 Pharmacology

FG-4592 represents one of several next generation PHI that has been optimized for multiple pharmacokinetic and pharmacodynamic parameters related to erythropoiesis, including selective inhibition of HIF prolyl and asparaginyl hydroxylases, potency, iron utilization, and ADME. FG-4592 represents one of several next generation HIF-PH inhibitors designed to selectively induce the expression of genes that mediate erythropoiesis for the treatment of anemia.

5.2 ATC Code

B03XA05

B - Blood and blood forming organs

B03 - Antianemic preparations

B03X - Other antianemic preparations

B03XA - Other antianemic preparations

B03XA05 - Roxadustat

5.3 Absorption, Distribution and Excretion

Absorption

Orally active

5.4 Mechanism of Action

FG-4592 is an orally active second generation HIF-PH inhibitor. Preclinical studies show that FG-4592 increases production of endogenous erythropoietin (EPO), increases iron mobilization and utilization, and overcomes the suppressive effects of inflammation on red blood cell production.

API SUPPLIERS

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Listed Suppliers

01

Metrochem API Private Limited

India

Pharmtech & Ingredients

Exhibiting

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

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India

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Roxadustat

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

02

Dr. Reddy's Laboratories

India

CPhI India 2024

Booth #RH.E02

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

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India

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Roxadustat

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

03

Faran Shimi Pharmaceutical

Iran

Pharma Manufacturing 2024

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Contact Supplier

Iran

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Roxadustat

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.

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04

Zhejiang Hengkang Pharmaceutical

China

Pharma Manufacturing 2024

Not Confirmed

Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

Contact Supplier

China

Virtual Booth

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Roxadustat

About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises.

05

Ami Lifesciences Private Limited

India

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

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India

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Digital Content

Roxadustat

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.

06

Bal Pharma

India

CPhI India 2024

Booth #5.I21

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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India

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Roxadustat

About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...

Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk actives. We are dedicated to enhancing patients' quality of life by offering products that are safe, effective, high-quality, and affordable. Bal Pharma's APIs and FDFs are produced at world-class manufacturing facilities. Our APIs are widely exported to Europe, the Far East, Latin America, Africa, the Middle East, and other global markets. Our FDFs are exported to semi-regulated and non-regulated markets, and we are now entering regulated markets.

Product Web Link

07

Beijing Sjar Technology Development

China

Pharma Manufacturing 2024

Not Confirmed

08

Hangzhou Longshine Bio-Tech

China

Pharma Manufacturing 2024

Not Confirmed

09

Hetero Drugs

India

Pharma Manufacturing 2024

Not Confirmed

10

Parsian Pharamceutical

Iran

Pharma Manufacturing 2024

Not Confirmed

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API Reference Price

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