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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

8 API Suppliers, 3 USDMF, 1 EU WC, 5 NDC API, 6 Listed Suppliers, $ API Reference Price

8 API Suppliers
3 USDMF
1 EU WC
5 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

FINISHED DOSAGE FORMULATIONS

8 FDF Dossiers, 3 FDA Orange Book, 3 Europe, 1 Canada, 1 Listed Dossiers

8 FDF Dossiers
3 FDA Orange Book
3 Europe
1 Canada
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Nanjing Well Pharmaceutical, 2 Actylis, 7 BASF, 5 Kerry, 1 Seppic

relatedExcipients
1 SPI Pharma
2 Nanjing Well Pharmaceutical
2 Actylis
7 BASF
5 Kerry
1 Seppic

EXCIPIENTS BY APPLICATIONS

10 Topical, 5 Co-Processed Excipients, 3 Solubilizers, 2 Emulsifying Agents, 2 Thickeners and Stabilizers, 2 Direct Compression, 1 Coating Systems & Additives, 1 Surfactant & Foaming Agents, 1 Lubricants & Glidants, 1 Granulation

excipientsByApplications
10 Topical
5 Co-Processed Excipients
3 Solubilizers
2 Emulsifying Agents
2 Thickeners and Stabilizers
2 Direct Compression
1 Coating Systems & Additives
1 Surfactant & Foaming Agents
1 Lubricants & Glidants
1 Granulation

DIGITAL CONTENT

14 NEWS #PharmaBuzz

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14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 Finished Drug Prices

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MARKET PLACE

5 APIs

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5 APIs

PATENTS & EXCLUSIVITIES

2 US Exclusivities, 2 Health Canada Patents

patents
2 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

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1 USP
1 Others

Eflornithine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,389

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

24DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

18 RELATED EXCIPIENT COMPANIES

28EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 68278-23-9, Eflornithine hcl, Dfmo, Dl-alpha-difluoromethylornithine hydrochloride, Eflornithinehydrochloride, 2-(difluoromethyl)-dl-ornithine monohydrochloride

Molecular Formula

C₆H₁₃ClF₂N₂O₂

Molecular Weight

218.63 g/mol

InChI Key

VKDGNNYJFSHYKD-UHFFFAOYSA-N

FDA UNII

UO07O10TCJ

An inhibitor of ornithine decarboxylase, the rate limiting enzyme of the polyamine biosynthetic pathway.

1 2D Structure

Eflornithine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2,5-diamino-2-(difluoromethyl)pentanoic acid;hydrochloride

2.1.2 InChI

InChI=1S/C6H12F2N2O2.ClH/c7-4(8)6(10,5(11)12)2-1-3-9;/h4H,1-3,9-10H2,(H,11,12);1H

2.1.3 InChI Key

VKDGNNYJFSHYKD-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C(CC(C(F)F)(C(=O)O)N)CN.Cl

2.2 Other Identifiers

2.2.1 UNII

UO07O10TCJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Alpha Difluoromethyl Ornithine

2. Alpha Difluoromethylornithine

3. Alpha-difluoromethyl Ornithine

4. Alpha-difluoromethylornithine

5. Difluoromethylornithine

6. Dl Alpha Difluoromethylornithine

7. Dl-alpha-difluoromethylornithine

8. Eflornithine

9. Eflornithine Monohydrochloride, Monohydrate

10. Mdl 71,782 A

11. Mdl-71,782 A

12. Mdl71,782 A

13. Ornidyl

14. Ornithine, Alpha-difluoromethyl

15. Rmi 71782

16. Vaniqa

2.3.2 Depositor-Supplied Synonyms

1. 68278-23-9

2. Eflornithine Hcl

3. Dfmo

4. Dl-alpha-difluoromethylornithine Hydrochloride

5. Eflornithinehydrochloride

6. 2-(difluoromethyl)-dl-ornithine Monohydrochloride

7. Eflornithine Hydrochloride Anhydrous

8. Dfmo Hcl

9. Eflornithine (hydrochloride)

10. Dfmo Hydrochloride

11. 2,5-diamino-2-(difluoromethyl)pentanoic Acid Hydrochloride

12. Vaniqa

13. Dfmo Hcl;eflornithine Hcl

14. Uo07o10tcj

15. Mls000069341

16. 2,5-diamino-2-(difluoromethyl)pentanoic Acid;hydrochloride

17. D,l-alpha-difluoromethylornithine Hydrochloride

18. Nsc-270295

19. H-alpha-difluoro-me-dl-orn-oh Hcl Ho

20. Ncgc00093850-01

21. Smr000058442

22. .alpha.-dfmo Hcl

23. Dsstox_cid_25765

24. Dsstox_rid_81107

25. Eflornithine . Hcl . Ho;dfmo . Hcl . Ho;alpha-difluoromethylornithine . Hcl . Ho

26. Dsstox_gsid_45765

27. Dfmo;mdl71782;rmi71782;alpha-difluoromethylornithine

28. Dl-ornithine, Monohydrochloride

29. Cas-96020-91-6

30. Ccris 5805

31. Nsc-337250

32. Einecs 269-532-0

33. Unii-uo07o10tcj

34. Sr-01000076229

35. 2-(difluoromethyl)-dl-ornithine Hydrochloride

36. 2-(difluoromethyl)-dl-ornithine Hcl

37. Dl-ornithine, 2-(difluoromethyl)-, Monohydrochloride

38. Nsc 270295

39. Nsc 337250

40. Opera_id_46

41. Eflornithine Hydrocloride

42. Ornithine, 2-(difluoromethyl)-, Monohydrochloride

43. Mls001332583

44. Chembl536971

45. Schembl3022583

46. (rs)-eflornithine Hydrochloride

47. Hy-b0744a

48. Dtxsid601019072

49. L-eflornithine Hydrochloride

50. Bcp11748

51. Dl-alpha-difluoromethylornithine Hcl

52. Tox21_111224

53. Tox21_500429

54. Ac-388

55. Mfcd00274036

56. Nsc270295

57. Akos015895186

58. Tox21_111224_1

59. Ccg-221733

60. Eflornithine Hydrochloride [mi]

61. Ks-1261

62. Lp00429

63. 2-(difluoromethyl)ornithine Hydrochloride

64. Ncgc00015316-05

65. Ncgc00261114-01

66. Dl-

67. A-difluoromethylornithine Hydrochloride

68. E0947

69. Eu-0100429

70. Ft-0630774

71. Dl-2-(difluoromethyl)-ornithine Hydrochloride

72. H-alpha-difluoro-me-dl-orn-oh . Hcl . Ho

73. Dl- Alpha -difluoromethylornithine Hydrochloride

74. 278e239

75. A836071

76. A836749

77. Dl--difluoromethylornithine Hydrochloride Monohydrate

78. Sr-01000076229-1

79. Dl-alpha-difluoromethylornithine Hydrochloride Hydrate

80. Q27291165

81. 2,5-diamino-2-(difluoromethyl)pentanoic Acid,hydrochloride

82. 2,5-bis(azanyl)-2-[bis(fluoranyl)methyl]pentanoic Acid Hydrochloride

83. 2,5-diamino-2-(difluoromethyl)pentanoic Acid Hydrochloride;eflornithine Hcl

84. 2,5-diamino-2-(difluoromethyl)pentanoic Acid, Monohydrochloride

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₆H₁₃ClF₂N₂O₂
Molecular Weight	218.63 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	218.0633617 g/mol
Monoisotopic Mass	218.0633617 g/mol
Topological Polar Surface Area	89.3 Å²
Heavy Atom Count	13
Formal Charge	0
Complexity	166
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Indication

Treatment of facial hirsutism in women.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Trypanocidal Agents

Agents destructive to the protozoal organisms belonging to the suborder TRYPANOSOMATINA. (See all compounds classified as Trypanocidal Agents.)

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

Ornithine Decarboxylase Inhibitors

Substances and drugs that inhibit or block the activity of ORNITHINE DECARBOXYLASE. (See all compounds classified as Ornithine Decarboxylase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Decarboxylase Inhibitor [EPC]; Decarboxylase Inhibitors [MoA]; Antiprotozoal [EPC]

5.3 ATC Code

D11AX

API SUPPLIERS

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USDMF

01

Rusan Pharma Ltd

India

Cosmoprof India

Not Confirmed

Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Contact Supplier

India

Virtual Booth

Digital Content

Eflornithine Hydrochloride Monohydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31780

Submission : 2017-06-29

Status : Active

Type : II

02

Lonza Ag

Switzerland

Cosmoprof India

Not Confirmed

03

Scinopharm Taiwan Ltd

Taiwan

Cosmoprof India

Not Confirmed

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EU WC

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NDC API

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Listed Suppliers

01

Rusan Pharma

India

Medlab Asia & Asia Health

Not Confirmed

Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Contact Supplier

India

Virtual Booth

Digital Content

Eflornithine Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.

02

EUROAPI

France

DDL Conference

Attending

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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France

Virtual Booth

Digital Content

Eflornithine

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.

03

HRV Global Life Sciences

India

CPHI Middle east

Attending

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

Eflornithine Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

04

Biotechnica DWC

Algeria

Medlab Asia & Asia Health

Not Confirmed

05

Micro Orgo Chem

India

Medlab Asia & Asia Health

Not Confirmed

06

OmnisMed Pharmaceuticals

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

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API Reference Price

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