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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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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 Intermediates Suppliers

5 Intermediates 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CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

15 NEWS #PharmaBuzz

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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

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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)

$ 422

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

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API Reference Price

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ISLAMABA","customer":"MEEZAN BANK LTD.","customerCountry":"PAKISTAN","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"210","totalValueFC":"3078.2","currency":"USD","unitRateINR":17243.607333333333,"date":"30-Oct-2024","totalValueINR":"258654.11","totalValueInUsd":"3078.2","indian_port":"Bombay Air","hs_no":"29280090","bill_no":"5294131","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"11, AJANTA SEA BREEZE, PLOT NO. 8,, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731004200,"product":"PHARMA INGREDIENTS - FLUVOXAMINE MALEATEUSP","address":"15, SATYAM APARTMENTS, JAGABHAI","city":"AHMEDABAD","supplier":"GREENCROSS EXPORT PRIVATE ","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"TO THE ORDER","customerCountry":"RUSSIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"58800","totalValueFC":"137175.6","currency":"INR","unitRateINR":57880,"date":"08-Nov-2024","totalValueINR":"11576000","totalValueInUsd":"137175.6","indian_port":"Ahmedabad Air","hs_no":"29252990","bill_no":"5458578","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"15, SATYAM APARTMENTS, JAGABHAI, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731004200,"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":"857.22","actualQuantity":"857.22","unit":"KGS","unitRateFc":"375","totalValueFC":"306337.5","currency":"USD","unitRateINR":30157.096404656913,"date":"08-Nov-2024","totalValueINR":"25851266.18","totalValueInUsd":"306337.5","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"5448844","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":1731263400,"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":"340.60","actualQuantity":"340.6","unit":"KGS","unitRateFc":"375","totalValueFC":"121715.1","currency":"USD","unitRateINR":30156.539166177332,"date":"11-Nov-2024","totalValueINR":"10271317.24","totalValueInUsd":"121715.1","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"5504066","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":1732559400,"product":"TAX INVOICE NO. IN2400000698 DT. 22.11.2024 ACTIVE PHARMA INGREDIENTS FLUVOXAMINE MALEATE","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"SHANGHAI - PU DONG","customer":"TO","customerCountry":"CHINA","quantity":"585.00","actualQuantity":"585","unit":"KGS","unitRateFc":"320","totalValueFC":"184398.8","currency":"USD","unitRateINR":26600.136905982905,"date":"26-Nov-2024","totalValueINR":"15561080.09","totalValueInUsd":"184398.8","indian_port":"Bombay Air","hs_no":"29252990","bill_no":"5921861","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"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":"344.78","actualQuantity":"344.78","unit":"KGS","unitRateFc":"375","totalValueFC":"123445.8","currency":"USD","unitRateINR":30214.537995243347,"date":"29-Nov-2024","totalValueINR":"10417368.41","totalValueInUsd":"123445.8","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"6039425","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":"2024","qtr":"Q2","strtotime":1712514600,"product":"FLUVOXAMINE MALEATE","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"HARMAN FINOCHEM","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"900","totalValueFC":"909.1","currency":"USD","unitRateINR":"75915","date":"08-Apr-2024","totalValueINR":"75915","totalValueInUsd":"909.1","indian_port":"Bombay Air","hs_no":"29280090","bill_no":"2929579","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"Fructu?s Gelabert, 6-8, planta 8 08970, Sant Joan Desp?, Barcelona, Spain Spain","customerAddress":"107A,VINAY BHAVYA COMPLEX"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"FLUVOXAMINE MALEATE USP (RE-IMP)(EXP VIDE SB NO.7807100\/28.01.2022)","address":"TYPE-C,PLOT NO.10,ROAD NO.8","city":"HYD-A.P.","supplier":"APOTEX INC","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"SRINI PHARMACEUTICALS","customerCountry":"INDIA","quantity":"106.22","actualQuantity":"106.22","unit":"KGS","unitRateFc":"475","totalValueFC":"51884.6","currency":"USD","unitRateINR":"40831.2","date":"22-Jul-2024","totalValueINR":"4337090.59","totalValueInUsd":"51884.6","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"4643523","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"50 STEINWAY DRIVE ETOBICOKE-ONTARIOCANADA MSW 6Y3SDNF Canada","customerAddress":"TYPE-C,PLOT NO.10,ROAD NO.8"}]

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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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 Manufacturers

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

Fluvoxamine Suppliers

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

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

Fluvoxamine USDMF

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

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

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

Fluvoxamine 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 Drug Master File in Japan (Fluvoxamine JDMF) empowers Fluvoxamine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Fluvoxamine 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 suppliers with JDMF on PharmaCompass.

Fluvoxamine CEP

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

A Fluvoxamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluvoxamine 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 suppliers with CEP (COS) on PharmaCompass.

Fluvoxamine WC

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

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

Fluvoxamine 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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fluvoxamine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluvoxamine NDC to their finished compounded human drug products, they may choose to do so.

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

Fluvoxamine GMP

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

Fluvoxamine CoA

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

Fluvoxamine CoA mostly includes findings from lab analyses of a specific batch. For each Fluvoxamine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluvoxamine EP), Fluvoxamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluvoxamine 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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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