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Eliglustat Tartrate

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4 EU WC
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8 NDC API
9 Listed Suppliers
$ API Reference Price

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1 Drugs in Development

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6 FDA Orange Book
4 Europe
1 Canada
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 DKSH, 1 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 4 DFE Pharma, 5 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 5 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

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Synopsis

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1,878

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118 RELATED EXCIPIENT COMPANIES

193EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Eliglustat hemitartrate, Cerdelga, 928659-70-5, Agalsidase beta, Eliglustat (hemitartrate), Genz-112638

Molecular Formula

C₅₀H₇₈N₄O₁₄

Molecular Weight

959.2 g/mol

InChI Key

KUBARPMUNHKBIQ-VTHUDJRQSA-N

FDA UNII

N0493335P3

Agalsidase beta is a recombinant human -galactosidase A similar to [agalsidase alfa]. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009. Agalsidase beta was granted FDA approval on 24 April 2003.

1 2D Structure

Eliglustat

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[(1R,2R)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-pyrrolidin-1-ylpropan-2-yl]octanamide;(2R,3R)-2,3-dihydroxybutanedioic acid

2.1.2 InChI

InChI=1S/2C23H36N2O4.C4H6O6/c2*1-2-3-4-5-6-9-22(26)24-19(17-25-12-7-8-13-25)23(27)18-10-11-20-21(16-18)29-15-14-28-20;5-1(3(7)8)2(6)4(9)10/h2*10-11,16,19,23,27H,2-9,12-15,17H2,1H3,(H,24,26);1-2,5-6H,(H,7,8)(H,9,10)/t2*19-,23-;1-,2-/m111/s1

2.1.3 InChI Key

KUBARPMUNHKBIQ-VTHUDJRQSA-N

2.1.4 Canonical SMILES

CCCCCCCC(=O)NC(CN1CCCC1)C(C2=CC3=C(C=C2)OCCO3)O.CCCCCCCC(=O)NC(CN1CCCC1)C(C2=CC3=C(C=C2)OCCO3)O.C(C(C(=O)O)O)(C(=O)O)O

2.1.5 Isomeric SMILES

CCCCCCCC(=O)N[C@H](CN1CCCC1)[C@@H](C2=CC3=C(C=C2)OCCO3)O.CCCCCCCC(=O)N[C@H](CN1CCCC1)[C@@H](C2=CC3=C(C=C2)OCCO3)O.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

N0493335P3

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cerdelga

2. Eliglustat

3. Genz-112638

2.3.2 Depositor-Supplied Synonyms

1. Eliglustat Hemitartrate

2. Cerdelga

3. 928659-70-5

4. Agalsidase Beta

5. Eliglustat (hemitartrate)

6. Genz-112638

7. 104138-64-9

8. Eliglustat Tartrate [usan]

9. Eliglustat (tartrate)

10. Genz 112638

11. 928659-70-5 (tartrate)

12. N0493335p3

13. N-[(1r,2r)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-pyrrolidin-1-ylpropan-2-yl]octanamide;(2r,3r)-2,3-dihydroxybutanedioic Acid

14. N-((1r,2r)-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl)octanamide Hemi((2r,3r)-2,3-dihydroxysuccinate)

15. Unii-n0493335p3

16. Cerdelga (tn)

17. Eliglustat L-tartrate

18. Eliglustat Tartrate [mi]

19. Chebi:83353

20. Eliglustat Tartrate (jan/usan)

21. Dtxsid50239166

22. Eliglustat Tartrate [jan]

23. Eliglustat Tartrategenz-112638

24. Eliglustat Tartrate [who-dd]

25. Hy-14885a

26. Genz-112638;eliglustat Hemitartrate

27. Cs-5423

28. Ex-a2301-1

29. Eliglustat Hemitartrate (genz-112638)

30. Eliglustat Tartrate [orange Book]

31. Ac-35333

32. Bis(n-((1r,2r)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(pyrrolidin-1- Ylmethyl)ethyl)octanamide) (2r,3r)-2,3-dihydroxybutanedioate

33. Octanamide, N-((1r,2r)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(1- Pyrrolidinylmethyl)ethyl)-, (2r,3r)-2,3-dihydroxybutanedioate (2:1)

34. Cerdelga Component Eliglustat Tartrate

35. S4433

36. C16736

37. D09894

38. Eliglustat Tartrate Component Of Cerdelga

39. Q27156779

40. (1r,2r)-octanoic Acid(2-(2',3'-dihydro-benzo(1,4) Dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl)-amide-l-tartaric Acid Salt

41. Bis{1-[(2r,3r)-3-(2,3-dihydro-1,4-benzodioxin-6-yl)-3-hydroxy-2-(octanoylamino)propyl]pyrrolidinium} (2r,3r)-2,3-dihydroxysuccinate

42. Bis{n-[(1r,2r)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl]octanamide} (2r,3r)-2,3-dihydroxysuccinic Acid

43. N-((1r,2r)-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl)octanamide ((2r,3r)-2,3-dihydroxysuccinate)(2:1)

44. Octanamide, N-((1r,2r)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(1-pyrrolidinylmethyl)ethyl)-, (2r,3r)-2,3-dihydroxybutanedioate (2:1)

2.4 Create Date

2011-06-02

3 Chemical and Physical Properties

Molecular Formula	C₅₀H₇₈N₄O₁₄
Molecular Weight	959.2 g/mol
Hydrogen Bond Donor Count	8
Hydrogen Bond Acceptor Count	16
Rotatable Bond Count	25
Exact Mass	958.55145317 g/mol
Monoisotopic Mass	958.55145317 g/mol
Topological Polar Surface Area	257 Å²
Heavy Atom Count	68
Formal Charge	0
Complexity	617
Isotope Atom Count	0
Defined Atom Stereocenter Count	6
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Indication

Agalsidase beta is indicated in the treatment of Fabry disease.

FDA Label

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).

Treatment of Gaucher disease Type 1 and Type 3, Treatment of Gaucher disease Type 2

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (-galactosidase-A deficiency).

5 Pharmacology and Biochemistry

5.1 Pharmacology

Agalsidase beta is a recombinant human -galactosidase A used as enzyme replacement therapy in the treatment of Fabry disease. It has a long duration of action and a wide therapeutic index. Patients should be counselled regarding the risk of infusion related reactions and hypersensitivity.

5.2 MeSH Pharmacological Classification

Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

alpha-Glucosidases [CS]; Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]

5.4 ATC Code

A16AX10

A16AB04

A - Alimentary tract and metabolism

A16 - Other alimentary tract and metabolism products

A16A - Other alimentary tract and metabolism products

A16AB - Enzymes

A16AB04 - Agalsidase beta

5.5 Absorption, Distribution and Excretion

Absorption

A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes reaches a C_max 5.0 1.1 g/mL with an AUC of 496 137 g\*min/mL.

Route of Elimination

After nonspecific proteolysis, the amino acids from protein drugs are reused for protein synthesis or further broken down and eliminated by the kidneys.

Volume of Distribution

A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes has a V_SS of 112 13 mL/kg.

Clearance

A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes has a clearance of 2.1 0.7 mL/min/kg.

5.6 Metabolism/Metabolites

Data regarding the metabolism of agalsidase beta is not readily available. However, protein drugs are expected to be degraded by proteases and other catalytic enzymes to smaller peptides and amino acids.

5.7 Biological Half-Life

agalsidase beta has a half like of 67 12 min for a 1 mg/kg dose with a mean infusion length of 115 minutes.

5.8 Mechanism of Action

-galactosidase A is uptaken by cells via the mannose 6 phosphate receptor. Agalsidase beta hydrolyzes globotriaosylceramide and other glycosphingolipids that would normally be hydrolyzed by endogenous -galactosidase A. Preventing the accumulation of glycosphingolipids prevents or reduces the severity of manifestations of Fabry disease such as renal failure, cardiomyopathy, or cerebrovascular events.

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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

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02

Metrochem API Private Limited

India

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

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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03

Dr. Reddy's Laboratories

India

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

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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KDMF VMF Others AUDIT

04

Biophore India Pharmaceuticals Pvt...

India

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

CPhI India 2024

Booth #1.A01

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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USDMF

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05

Cipla

India

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euroPLX 86 Munich

Not Confirmed

06

Raks Pharma

India

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

euroPLX 86 Munich

Not Confirmed

07

Apotex Pharmachem

Canada

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

euroPLX 86 Munich

Not Confirmed

08

Maithri Drugs

India

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euroPLX 86 Munich

Not Confirmed

09

Maithri Drugs

India

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

euroPLX 86 Munich

Not Confirmed

10

Azico Biophore India Pvt. Ltd

India

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

euroPLX 86 Munich

Not Confirmed

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API Reference Price

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15 API Suppliers

8 USDMF

4 EU WC

1 KDMF

8 NDC API

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$ API Reference Price

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1 Drugs in Development

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12 FDF Dossiers

6 FDA Orange Book

4 Europe

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RELATED EXCIPIENT COMPANIES

1 SPI Pharma

2 DKSH

1 Faran Shimi Pharmaceutical

8 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

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2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

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5 Ideal Cures Pvt Ltd

29 Kerry

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6 Lonza Capsugel

5 Microlex e.U

1 Novo Excipients

1 Pharmatrans-Sanaq

1 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

6 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 The Dow Chemical Company

1 Vasa Pharmachem

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43 Coating Systems & Additives

37 Fillers, Diluents & Binders

20 Controlled & Modified Release

19 Direct Compression

11 Co-Processed Excipients

10 Granulation

10 Thickeners and Stabilizers

7 Film Formers & Plasticizers

6 Disintegrants & Superdisintegrants

5 Empty Capsules

4 Vegetarian Capsules

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4 Coloring Agents

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2 Rheology Modifiers

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10 Annual Reports

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