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ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 1 CEP/COS, 6 JDMF, 4 EU WC, 7 NDC API, 25 Listed Suppliers, $ API Reference Price

38 API Suppliers
13 USDMF
1 CEP/COS
6 JDMF
4 EU WC
7 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

135 FDF Dossiers, 63 FDA Orange Book, 30 Europe, 8 Canada, 20 Australia, 4 South Africa, 10 Listed Dossiers

135 FDF Dossiers
63 FDA Orange Book
30 Europe
8 Canada
20 Australia
4 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 1 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 8 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 17 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 17 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

relatedExcipients
1 Minakem
2 Evonik
1 Rochem International Inc
17 SPI Pharma
2 Seqens
8 DKSH
5 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
12 Gangwal Healthcare
4 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
6 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
26 BASF
1 Clariant
17 Corel Pharma Chem
3 DFE Pharma
2 Finar
10 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
17 Kerry
4 Kima Chemical
6 Lonza Capsugel
11 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
2 Novo Excipients
4 Pharmatrans-Sanaq
5 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
20 Roquette
14 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
3 The Dow Chemical Company
1 Valens Pharmachem
3 Vasa Pharmachem
2 Vertellus

EXCIPIENTS BY APPLICATIONS

67 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 41 Controlled & Modified Release, 36 Direct Compression, 31 Thickeners and Stabilizers, 25 Solubilizers, 24 Disintegrants & Superdisintegrants, 23 Granulation, 22 Lubricants & Glidants, 21 Taste Masking, 18 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 16 Parenteral, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 5 Surfactant & Foaming Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

15 NEWS #PharmaBuzz

media
15 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 36 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
36 Finished Drug Prices

MARKET PLACE

15 APIs, 1 Intermediates

marketPlace
15 APIs
1 Intermediates

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 4 JP , 1 Others

otherSolutions
1 EDQM
1 USP
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 420

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

135

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

19,797,462

Annual Reports (USD Million)

Finished Drug Prices

262 RELATED EXCIPIENT COMPANIES

467EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Luvox, 61718-82-9, Fevarin, Faverin, Luvox cr, Du23000

Molecular Formula

C₁₉H₂₅F₃N₂O₆

Molecular Weight

434.4 g/mol

InChI Key

LFMYNZPAVPMEGP-PIDGMYBPSA-N

FDA UNII

5LGN83G74V

A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS.

1 2D Structure

Fluvoxamine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(Z)-but-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

2.1.2 InChI

InChI=1S/C15H21F3N2O2.C4H4O4/c1-21-10-3-2-4-14(20-22-11-9-19)12-5-7-13(8-6-12)15(16,17)18;5-3(6)1-2-4(7)8/h5-8H,2-4,9-11,19H2,1H3;1-2H,(H,5,6)(H,7,8)/b20-14+;2-1-

2.1.3 InChI Key

LFMYNZPAVPMEGP-PIDGMYBPSA-N

2.1.4 Canonical SMILES

COCCCCC(=NOCCN)C1=CC=C(C=C1)C(F)(F)F.C(=CC(=O)O)C(=O)O

2.1.5 Isomeric SMILES

COCCCC/C(=N\OCCN)/C1=CC=C(C=C1)C(F)(F)F.C(=C\C(=O)O)\C(=O)O

2.2 Other Identifiers

2.2.1 UNII

5LGN83G74V

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Desiflu

2. Du 23000

3. Du-23000

4. Du23000

5. Dumirox

6. Faverin

7. Fevarin

8. Floxyfral

9. Fluvoxadura

10. Fluvoxamin Al

11. Fluvoxamin Beta

12. Fluvoxamin Neuraxpharm

13. Fluvoxamin Ratiopharm

14. Fluvoxamin Stada

15. Fluvoxamin-neuraxpharm

16. Fluvoxamin-ratiopharm

17. Fluvoxamina Geminis

18. Fluvoxamine

19. Fluvoxamine Maleate, (e)-isomer

20. Fluvoxamine, (z)-isomer

21. Geminis, Fluvoxamina

22. Luvox

23. Novo Fluvoxamine

24. Novo-fluvoxamine

25. Nu Fluvoxamine

26. Nu-fluvoxamine

27. Pms Fluvoxamine

28. Pms-fluvoxamine

29. Ratio Fluvoxamine

30. Ratio-fluvoxamine

2.3.2 Depositor-Supplied Synonyms

1. Luvox

2. 61718-82-9

3. Fevarin

4. Faverin

5. Luvox Cr

6. Du23000

7. Fluvoxamine (maleate)

8. Du-23000

9. Fluvoxamine Hydrogenmaleate

10. 54739-20-7

11. Nsc-759602

12. 5lgn83g74v

13. (z)-but-2-enedioic Acid;2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

14. 1-pentanone, 5-methoxy-1-(4-(trifluoromethyl)phenyl)-, O-(2-aminoethyl)oxime, (e)-, (z)-2-butenedioate (1:1)

15. Fluvoxaminemaleate

16. Floxyfral

17. (e)-5-methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-one O-(2-aminoethyl) Oxime Maleate

18. Mk-264

19. (e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-o-(2-aminoethyl)oxime Maleate

20. Fluvoxamine Maleate [usan]

21. (2z)-but-2-enedioic Acid; (e)-(2-aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine

22. Smr000466268

23. Smr000653482

24. Sr-01000075613

25. Sme 3110

26. Unii-5lgn83g74v

27. Depromel

28. Fluvoxamine Maleate [usan:usp]

29. Luvox (tn)

30. Nsc 309469

31. Fluvoxamine Maleate, Solid

32. 5-methoxy-4'-trifluoromethylvalerophenone (e)-o-2-aminoethyloxime Monomaleate

33. Fluvoxamine Maleate- Bio-x

34. 5-methoxy-4'-(trifluoromethyl)valerophenone (e)-o-(2-aminoethyl)oxime, Maleate (1:1)

35. Chembl1409

36. Schembl35225

37. Mls000028469

38. Mls000758271

39. Mls001076285

40. Mls001304717

41. Mls001401391

42. Chebi:5139

43. Dtxsid3042558

44. Fluvoxamine Maleate [mi]

45. Hy-b0103a

46. Fluvoxamine Maleate [jan]

47. Fluvoxamine Maleate (jp17/usp)

48. Hms1571g11

49. Hms2098g11

50. Hms3261d11

51. Hms3412a13

52. Hms3676a13

53. Hms3715g11

54. Hms3884k11

55. Pharmakon1600-01505604

56. Fluvoxamine Maleate [vandf]

57. (2-aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine; But-2-enedioic Acid

58. Fluvoxamine Maleate [mart.]

59. Sme-3110

60. Tox21_500495

61. Fluvoxamine Maleate [usp-rs]

62. Fluvoxamine Maleate [who-dd]

63. Mfcd00269809

64. Nsc309469

65. Nsc759602

66. S1336

67. Akos015961142

68. Ac-9541

69. Ccg-213494

70. Cs-1839

71. Nsc 759602

72. Nsc-309469

73. Fluvoxamine Maleate [orange Book]

74. Ncgc00093897-01

75. Ncgc00093897-02

76. Ncgc00261180-01

77. (e)-5-methoxy-1-(4-(trifluoromethyl)phenyl)-1-pentanone O-(2-aminoethyl)oxime (z)-2-butenedioate (1:1)

78. As-11790

79. Bf164482

80. Fluvoxamine Maleate [ep Monograph]

81. Smr000058449

82. Fluvoxamine Maleate [usp Monograph]

83. Eu-0100495

84. F0858

85. D00824

86. F 2802

87. 739f183

88. A833394

89. Sr-01000075613-1

90. Sr-01000075613-3

91. Sr-01000075613-4

92. Sr-01000075613-6

93. Fluvoxamine Maleate, British Pharmacopoeia (bp) Reference Standard

94. Fluvoxamine Maleate, European Pharmacopoeia (ep) Reference Standard

95. Fluvoxamine Maleate, United States Pharmacopeia (usp) Reference Standard

96. (e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-(2-aminoethyl)oxime Maleate

97. 5-methoxy-1-(4-trifluoromethyl-phenyl)-pentan-1-one O-(2-amino-ethyl)-oxime Maleate

98. Fluvoxamine For System Suitability, European Pharmacopoeia (ep) Reference Standard

99. Fluvoxamine Maleate, 1.0 Mg/ml In Methanol ((as Free Base)), Certified Reference Material

100. Fluvoxamine Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

101. (z)-2-butenedioic Acid; 2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

102. (z)-but-2-enedioic Acid; 2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

103. 1-pentanone, 5-methoxy-1-[4-(trifluoromethyl)phenyl]-,o-(2-aminoethyl)oxime, (1e)-, (2z)-2-butenedioate (1:1)

104. 2-[({(1e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene}amino)oxy]ethanamine (2z)-but-2-enedioate

105. 5-methoxy-4'-(trifluoromethyl)valerophenone-(e)-o-(2-aminoethyl)oxime Maleate (1:1)

2.4 Create Date

2006-10-23

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₅F₃N₂O₆
Molecular Weight	434.4 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	11
Rotatable Bond Count	11
Exact Mass	434.16647101 g/mol
Monoisotopic Mass	434.16647101 g/mol
Topological Polar Surface Area	131 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	446
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	2
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Fluvoxamine maleate
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet; Capsule, extended release
Route	Oral
Strength	25mg; 150mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

2 of 6
Drug Name	Luvox
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet
Route	oral; Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Ani Pharms; Jazz

3 of 6
Drug Name	Luvox cr
Drug Label	LUVOX CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones....
Active Ingredient	Fluvoxamine maleate
Dosage Form	Capsule, extended release
Route	Oral
Strength	150mg; 100mg
Market Status	Prescription
Company	Jazz Pharms

4 of 6
Drug Name	Fluvoxamine maleate
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet; Capsule, extended release
Route	Oral
Strength	25mg; 150mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

5 of 6
Drug Name	Luvox
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet
Route	oral; Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Ani Pharms; Jazz

6 of 6
Drug Name	Luvox cr
Drug Label	LUVOX CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones....
Active Ingredient	Fluvoxamine maleate
Dosage Form	Capsule, extended release
Route	Oral
Strength	150mg; 100mg
Market Status	Prescription
Company	Jazz Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

Antidepressive Agents, Second-Generation

A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)

Cytochrome P-450 CYP1A2 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inhibitors.)

Cytochrome P-450 CYP2C19 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2C19. (See all compounds classified as Cytochrome P-450 CYP2C19 Inhibitors.)

Selective Serotonin Reuptake Inhibitors

Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin Uptake Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]

API SUPPLIERS

01

LGM Pharma

U.S.A

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

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Veranova

U.S.A

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Temad Co

Iran

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Cohance Lifesciences

India

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Jai Radhe Sales

India

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HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Medichem S.A

Spain

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TAPI Technology & API Services

Israel

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Jewim Pharmaceutical

China

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Dasami Lab

India

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Listed Suppliers

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LGM Pharma

U.S.A

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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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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Temad Co

Iran

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About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.

03

Cohance Lifesciences

India

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India

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Fluvoxamine

About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.

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Jai Radhe Sales

India

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India

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Fluvoxamine

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

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05

HRV Global Life Sciences

India

VMX

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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Digital Content

Fluvoxamine

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.

06

Medichem S.A

Spain

VMX

Not Confirmed

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

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Fluvoxamine

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

07

Dasami Lab

India

VMX

Not Confirmed

08

Dasami Lab

India

VMX

Not Confirmed

09

Hetero Drugs

India

VMX

Not Confirmed

10

Olon S.p.A

Italy

VMX

Not Confirmed

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API Reference Price

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INC","customerCountry":"CANADA","quantity":"515.46","actualQuantity":"515.46","unit":"KGS","unitRateFc":"375","totalValueFC":"184558","currency":"USD","unitRateINR":30214.795813448181,"date":"26-Nov-2024","totalValueINR":"15574518.65","totalValueInUsd":"184558","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"5926325","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"TYPE-C,PLOT NO.10,ROAD NO.8, HYD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"FLUVOXAMINE MALEATE","address":"TYPE-C,PLOT NO.10,ROAD NO.8","city":"HYD-A.P.","supplier":"SRINI PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"BIOLAB SANUS FARMACEUTICA LTDA","customerCountry":"BRAZIL","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"800","totalValueFC":"193518.6","currency":"USD","unitRateINR":65772.308000000005,"date":"05-Dec-2024","totalValueINR":"16443077","totalValueInUsd":"193518.6","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"6190548","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"TYPE-C,PLOT NO.10,ROAD NO.8, HYD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"FLUVOXAMINE MALEATE","address":"TYPE-C,PLOT NO.10,ROAD NO.8","city":"HYD-A.P.","supplier":"SRINI PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"CANADA","quantity":"293.87","actualQuantity":"293.87","unit":"KGS","unitRateFc":"375","totalValueFC":"105303.2","currency":"USD","unitRateINR":30447.165038962808,"date":"27-Dec-2024","totalValueINR":"8947508.39","totalValueInUsd":"105303.2","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"6806091","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"TYPE-C,PLOT NO.10,ROAD NO.8, HYD-A.P.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689273000,"product":"REIMPORT OF REJECTED GOODS-FLUVOXAMINE MALEATE BATCH NO:862022005B","address":"PRESTIGE ATRIUM,6TH LEVEL UNIT NO. 6,03, NO.1, CENTRAL STREET,OPP EMPI","city":"HOTEL SHIVAJINAGAR BANGALORE,KARNAT","supplier":"CHONG DAH PHARMACEUTICAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"LAKE CHEMICALS PRIVATE ","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"575","totalValueFC":"29606.7","currency":"USD","unitRateINR":"48667.2","date":"14-Jul-2023","totalValueINR":"2433363.765","totalValueInUsd":"29606.7","indian_port":"BANGALORE AIR","hs_no":"29280090","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PRESTIGE ATRIUM,6TH LEVEL UNIT NO. 6,03, NO.1, CENTRAL STREET,OPP EMPI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697740200,"product":"(RE-IMPORT OF REJECTED GOODS) FLUVOXAMINE MALEATE BATCH 862023001B","address":"5TH FLOOR,LAXMINARAYAN COMPLEX","city":"BANGALORE, KARNATAKA","supplier":"CHONG DAH PHARMACEUTICAL ","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"LAKE CHEMICALS PRIVATE ","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"575","totalValueFC":"29676.9","currency":"USD","unitRateINR":"49399.7","date":"20-Oct-2023","totalValueINR":"2469983.44","totalValueInUsd":"29676.9","indian_port":"Bangalore Air","hs_no":"29280090","bill_no":"8385870","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"3F, NO 158 SECTOR 2, MIN CHUAN ROAD, WEST CENTRAL DIST. TAINAN CITY 70042 ., , TAIWAN TAIWAN","customerAddress":"5TH FLOOR,LAXMINARAYAN COMPLEX"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720549800,"product":"FLUVOXAMINE MALEATE USP BATCH NO : 610513","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"ENDO OPERATIONS (GX\/SI SUPPLY)","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"334.00","actualQuantity":"334","unit":"KGS","unitRateFc":"480","totalValueFC":"162507.8","currency":"USD","unitRateINR":"40671.3","date":"10-Jul-2024","totalValueINR":"13584204.75","totalValueInUsd":"162507.8","indian_port":"Madras Air","hs_no":"29349990","bill_no":"4425884","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"1ST FLOOR MINERVA HOUSESIM MONS COURTS ROADBALLS BRIDGE, DUBLIN 4 IRELAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]

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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Drugs in Development

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Europe

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BGP Products BV

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02

BGP PRODUCTS Srl(GRUPPO MYLAN)

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03

BGP Products B.V.

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04

VIATRIS ITALIA SRL

U.S.A

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05

VIATRIS ITALIA SRL

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06

Viatris Pharma GmbH

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07

Viatris Pharma GmbH

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08

EG SpA

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09

EG SpA

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22033

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22033

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ABOUT THIS PAGE

Fluvoxamine Maleate Manufacturers

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

Fluvoxamine Maleate Suppliers

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

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

Fluvoxamine Maleate USDMF

A Fluvoxamine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluvoxamine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Fluvoxamine Maleate DMFs exist exist since differing nations have different regulations, such as Fluvoxamine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Fluvoxamine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Fluvoxamine Maleate USDMF includes data on Fluvoxamine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluvoxamine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Fluvoxamine Maleate suppliers with USDMF on PharmaCompass.

Fluvoxamine Maleate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Fluvoxamine Maleate Drug Master File in Japan (Fluvoxamine Maleate JDMF) empowers Fluvoxamine Maleate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Fluvoxamine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Fluvoxamine Maleate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Fluvoxamine Maleate suppliers with JDMF on PharmaCompass.

Fluvoxamine Maleate CEP

A Fluvoxamine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Fluvoxamine Maleate Certificate of Suitability (COS). The purpose of a Fluvoxamine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluvoxamine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluvoxamine Maleate to their clients by showing that a Fluvoxamine Maleate CEP has been issued for it. The manufacturer submits a Fluvoxamine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluvoxamine Maleate CEP holder for the record. Additionally, the data presented in the Fluvoxamine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluvoxamine Maleate DMF.

A Fluvoxamine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluvoxamine Maleate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Fluvoxamine Maleate suppliers with CEP (COS) on PharmaCompass.

Fluvoxamine Maleate WC

A Fluvoxamine Maleate written confirmation (Fluvoxamine Maleate WC) is an official document issued by a regulatory agency to a Fluvoxamine Maleate manufacturer, verifying that the manufacturing facility of a Fluvoxamine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fluvoxamine Maleate APIs or Fluvoxamine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fluvoxamine Maleate WC (written confirmation) as part of the regulatory process.

click here to find a list of Fluvoxamine Maleate suppliers with Written Confirmation (WC) on PharmaCompass.

Fluvoxamine Maleate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Fluvoxamine Maleate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fluvoxamine Maleate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Fluvoxamine Maleate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fluvoxamine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluvoxamine Maleate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fluvoxamine Maleate suppliers with NDC on PharmaCompass.

Fluvoxamine Maleate GMP

Fluvoxamine Maleate 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 Fluvoxamine Maleate 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 Fluvoxamine Maleate GMP manufacturer or Fluvoxamine Maleate GMP API supplier for your needs.

Fluvoxamine Maleate CoA

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

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

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

38 API Suppliers

13 USDMF

1 CEP/COS

6 JDMF

4 EU WC

7 NDC API

25 Listed Suppliers

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DEVELOPMENTS

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DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons