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Agomelatine

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 3 USDMF, 8 EU WC, 4 KDMF, 3 NDC API, 25 Listed Suppliers, $ API Reference Price

30 API Suppliers
3 USDMF
8 EU WC
4 KDMF
3 NDC API
25 Listed Suppliers
$ API Reference Price

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

25 FDF Dossiers, 17 Europe, 1 South Africa, 7 Listed Dossiers

25 FDF Dossiers
17 Europe
1 South Africa
7 Listed Dossiers

GLOBAL SALES INFORMATION

14 Finished Drug Prices

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14 Finished Drug Prices

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5 APIs

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5 APIs

REF. STANDARDS & IMPURITIES

5 Others

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ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 138112-76-2, Thymanax, Valdoxan, N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide, N-(2-(7-methoxynaphthalen-1-yl)ethyl)acetamide, S20098

Molecular Formula

C₁₅H₁₇NO₂

Molecular Weight

243.30 g/mol

InChI Key

YJYPHIXNFHFHND-UHFFFAOYSA-N

FDA UNII

137R1N49AD

Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was developed in Europe by Servier Laboratories Ltd. and submitted to the European Medicines Agency (EMA) in 2005. The Committee for Medical Products for Human Use (CHMP) recommended refusal of marketing authorization on 27 July 2006. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis. The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.

1 2D Structure

Agomelatine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide

2.1.2 InChI

InChI=1S/C15H17NO2/c1-11(17)16-9-8-13-5-3-4-12-6-7-14(18-2)10-15(12)13/h3-7,10H,8-9H2,1-2H3,(H,16,17)

2.1.3 InChI Key

YJYPHIXNFHFHND-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(=O)NCCC1=CC=CC2=C1C=C(C=C2)OC

2.2 Other Identifiers

2.2.1 UNII

137R1N49AD

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Ago 178

2. Ago-178

3. Ago178

4. N-(2-(7-methoxy-1-naphthyl)ethyl)acetamide

5. S 20098

6. S-20098

7. S20098

8. Thymanax

9. Valdoxan

2.3.2 Depositor-Supplied Synonyms

1. 138112-76-2

2. Thymanax

3. Valdoxan

4. N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide

5. N-(2-(7-methoxynaphthalen-1-yl)ethyl)acetamide

6. S20098

7. S-20098

8. Agomelatine [inn]

9. Melitor

10. Ago-178

11. S 20098

12. Acetamide, N-[2-(7-methoxy-1-naphthalenyl)ethyl]-

13. N-(2-(7-methoxy-1-naphthyl)ethyl)acetamide

14. N-(2-(7-methoxynaphth-1-yl)ethyl)acetamide

15. N-(2-(7-methoxy-1-naphthalenyl)ethyl)acetamide

16. Chembl10878

17. 137r1n49ad

18. N-[2-(7-methoxy-1-naphthalenyl)ethyl]acetamide

19. Agomelatine (inn)

20. Ncgc00253646-01

21. N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide

22. Acetamide, N-(2-(7-methoxy-1-naphthalenyl)ethyl)-

23. N-[2-(7-methoxy-naphthalen-1-yl)-ethyl]-acetamide

24. Ago 178

25. Valdoxan (tn)

26. Unii-137r1n49ad

27. Ago178

28. N-[2-(7-methoxynaphth-1-yl)ethyl]acetamide

29. Sr-01000944938

30. Agomelatine [inn:ban]

31. Ago178c

32. Agomelatine-[d4]

33. Awy

34. Agomelatine- Bio-x

35. Mfcd00916659

36. Agomelatine [mi]

37. Agomelatine [mart.]

38. Dsstox_cid_31431

39. Dsstox_rid_97317

40. Dsstox_gsid_57642

41. Agomelatine [who-dd]

42. Gtpl198

43. Mls006011913

44. Schembl114476

45. Agomelatine [ema Epar]

46. Zinc5608

47. Dtxsid3057642

48. Agomelatine, >=98% (hplc)

49. Chebi:134990

50. Bcpp000421

51. Hms3604n09

52. Hms3648g18

53. Hms3654b07

54. Hms3884a07

55. Bcp02084

56. Tox21_113772

57. Bbl029084

58. Bdbm50035179

59. Pdsp1_001305

60. Pdsp1_001784

61. Pdsp2_001289

62. Pdsp2_001767

63. S1243

64. Stl237728

65. Akos005145681

66. Ac-3395

67. Bcp9000250

68. Ccg-221950

69. Cs-0740

70. Db06594

71. Ks-1247

72. Sb19508

73. Ncgc00253646-10

74. Ba167079

75. Hy-17038

76. Smr002530056

77. Am20090763

78. B2262

79. Cas-138112-76-2

80. Ft-0657383

81. Sw219177-1

82. A19445

83. D02578

84. Ab01274769-01

85. Ab01274769_02

86. 112a762

87. L000528

88. Q395229

89. Q-102507

90. Sr-01000944938-1

91. Sr-01000944938-3

92. F0001-2383

93. (4-chlorophenyl)-[(9h-fluoren-9-ylmethoxycarbonylamino)]-aceticacid

94. N-[2-(7-methoxy-naphthalen-1-yl)-ethyl]-acetamide(agomelatine)

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₇NO₂
Molecular Weight	243.30 g/mol
XLogP3	2.7
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	4
Exact Mass	243.125928785 g/mol
Monoisotopic Mass	243.125928785 g/mol
Topological Polar Surface Area	38.3 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	280
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

Agomelatine is indicated to treat major depressive episodes in adults.

Treatment of major depressive episodes in adults.

Treatment of major depressive episodes

5 Pharmacology and Biochemistry

5.1 Pharmacology

Agomelatine resynchronises circadian rhythms in animal models of delayed sleep phase syndrome and other circadian rhythm disruptions. It increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin. Agomelatine has shown an antidepressant-like effect in animal depression models, (learned helplessness test, despair test, and chronic mild stress) circadian rhythm desynchronisation, and in stress and anxiety models. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset. Controlled studies in humans have shown that agomelatine is as effective as the SSRI antidepressants paroxetine and sertraline in the treatment of major depression

5.2 MeSH Pharmacological Classification

Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

5.3 ATC Code

N06AX22

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

N - Nervous system

N06 - Psychoanaleptics

N06A - Antidepressants

N06AX - Other antidepressants

N06AX22 - Agomelatine

5.4 Absorption, Distribution and Excretion

Absorption

Bioavailability is less than 5%.

5.5 Metabolism/Metabolites

Hepatic (90% CYP1A2 and 10% CYP2C9).

5.6 Biological Half-Life

<2 hours

5.7 Mechanism of Action

The novel antidepressant agent, agomelatine, behaves as an agonist at melatonin receptors (MT1 and MT2) and as an antagonist at serotonin (5-HT)(2C) receptors.

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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LGM Pharma

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03

Dr. Reddy's Laboratories

India

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HRV Global Life Sciences

India

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05

MSN Laboratories

India

India

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Not Confirmed

10

Alembic Pharmaceuticals Limited

India

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Dr. Reddy's Laboratories

India

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Agomelatine Phosphoric Acid IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

02

Alembic Pharmaceuticals Limited

India

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Alembic Pharmaceuticals Limited

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Mehta API

India

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01

Biophore India Pharmaceuticals Pvt ...

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About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

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LGM Pharma

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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HRV Global Life Sciences

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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.

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Ningbo Syntame Biotech

China

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Precise Group

India

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Precise Group

India

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About the Company : Indian Pharmaceutical Company, Precise Group is emerging as a global player in several verticals in healthcare. The Mumbai based drug manufacturing company’s strength lies in a s...

Indian Pharmaceutical Company, Precise Group is emerging as a global player in several verticals in healthcare. The Mumbai based drug manufacturing company’s strength lies in a strong network of industry professionals who care capable of handling the development of APIs, several Ready-to-fill Pellets and other intermediates, and chemicals. The company’s influence has a universal reach coordinating with multi-levels of global healthcare service providers for generic drugs. It holds a valued equity in niche pharma sectors in USA, Europe and Africa. Precise Group’s business encompasses the protection of the interest of their shareholders, is complaint with international regulatory bodies and meets the protocol favored in any region as a pharma suppler spanning developed and new markets. The technologically advanced manufacturing hub near Mumbai conducts manufacturing programs to sustain quality drugs at cost effect prices.

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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Europe

01

Helvepharm AG

France

Medlab Asia & Asia Health

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Agomelatine

Brand Name : Agomelatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

02

Helvepharm AG

France

Medlab Asia & Asia Health

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Agomelatine

Brand Name : Agomelatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

03

Les Laboratoires Servier,

Canada

Medlab Asia & Asia Health

Not Confirmed

04

Les Laboratoires a Server, Neuilly Sur S...

Medlab Asia & Asia Health

Not Confirmed

08

Spirig HealthCare AG

Switzerland

Medlab Asia & Asia Health

Not Confirmed

09

Spirig HealthCare AG

Switzerland

Medlab Asia & Asia Health

Not Confirmed

10

Country

Medlab Asia & Asia Health

Not Confirmed

Only 10 entries up to this point, click to access all

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South Africa

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Listed Dossiers

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Global Sales Information

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Finished Drug Prices

01

Brand Name : Agomelatin Zentiva

France

Antibody Engineering

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Agomelatine

Dosage Form : Filmtabl

Dosage Strength : 25mg

Price Per Pack (Euro) : 26.2

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

02

Brand Name : Agomelatin Zentiva

France

Antibody Engineering

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Agomelatine

Dosage Form : Filmtabl

Dosage Strength : 25mg

Price Per Pack (Euro) : 88.95

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

03

Brand Name : Valdoxan

Canada

Country

Antibody Engineering

Not Confirmed

Only 10 entries up to this point, click to access all

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Market Place

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APIs

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REF. STANDARDS & IMPURITIES

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Others

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ANALYTICAL

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BioAnalytical Methods

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers

3 USDMF

8 EU WC

4 KDMF

3 NDC API

25 Listed Suppliers

$ API Reference Price

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

25 FDF Dossiers

17 Europe

1 South Africa

7 Listed Dossiers

GLOBAL SALES INFORMATION

14 Finished Drug Prices

MARKET PLACE

5 APIs

REF. STANDARDS & IMPURITIES

5 Others

ANALYTICAL

1 BioAnalytical Methods

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 3,161

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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