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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

Fluvoxamine
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 Weight 434.4 g/mol
Molecular Formula C19H25F3N2O6
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count11
Rotatable Bond Count11
Exact Mass434.16647101 g/mol
Monoisotopic Mass434.16647101 g/mol
Topological Polar Surface Area131 Ų
Heavy Atom Count30
Formal Charge0
Complexity446
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameFluvoxamine maleate
PubMed HealthFluvoxamine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent
Drug LabelFluvoxamine 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 IngredientFluvoxamine maleate
Dosage FormTablet; Capsule, extended release
RouteOral
Strength25mg; 150mg; 100mg; 50mg
Market StatusPrescription
CompanyAnchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

2 of 6  
Drug NameLuvox
PubMed HealthFluvoxamine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent
Drug LabelFluvoxamine 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 IngredientFluvoxamine maleate
Dosage FormTablet
Routeoral; Oral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyAni Pharms; Jazz

3 of 6  
Drug NameLuvox cr
Drug LabelLUVOX 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 IngredientFluvoxamine maleate
Dosage FormCapsule, extended release
RouteOral
Strength150mg; 100mg
Market StatusPrescription
CompanyJazz Pharms

4 of 6  
Drug NameFluvoxamine maleate
PubMed HealthFluvoxamine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent
Drug LabelFluvoxamine 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 IngredientFluvoxamine maleate
Dosage FormTablet; Capsule, extended release
RouteOral
Strength25mg; 150mg; 100mg; 50mg
Market StatusPrescription
CompanyAnchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

5 of 6  
Drug NameLuvox
PubMed HealthFluvoxamine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent
Drug LabelFluvoxamine 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 IngredientFluvoxamine maleate
Dosage FormTablet
Routeoral; Oral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyAni Pharms; Jazz

6 of 6  
Drug NameLuvox cr
Drug LabelLUVOX 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 IngredientFluvoxamine maleate
Dosage FormCapsule, extended release
RouteOral
Strength150mg; 100mg
Market StatusPrescription
CompanyJazz 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]

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OF,.","customerCountry":"RUSSIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"54860","totalValueFC":"31369.1","currency":"INR","unitRateINR":54098.57,"date":"20-Jan-2025","totalValueINR":"2704928.5","totalValueInUsd":"31369.1","indian_port":"Bangalore Air","hs_no":"29280090","bill_no":"7426779","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"5TH FLOOR,LAXMINARAYAN COMPLEX, BANGALORE, KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738089000,"product":"PHARMACEUTICAL RAW MATERIAL TAX INVNO. 2425\/APM00001 FLUVOXAMINEMALEATE USP","address":"315-318,JANKI CENTRE,PL NO.29,SHAH","city":"MUMBAI, MAHARASHTRA","supplier":"MEHTA API","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"NATIONAL CREDIT","customerCountry":"BANGLADESH","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"500","totalValueFC":"4863.7","currency":"USD","unitRateINR":41939,"date":"29-Jan-2025","totalValueINR":"419390","totalValueInUsd":"4863.7","indian_port":"Bombay Air","hs_no":"29280090","bill_no":"7714162","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"315-318,JANKI CENTRE,PL NO.29,SHAH, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738261800,"product":"TAX INVOICE NO. IN2400000994 DATE.30.01.2025 ACTIVE PHARMA INGREDIENTS FLUVOXAMINE MALEATE EP, ALONG WITH THE TWO DATA L","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"TO","customerCountry":"NETHERLANDS","quantity":"1600.00","actualQuantity":"1600","unit":"KGS","unitRateFc":"335","totalValueFC":"530845.7","currency":"USD","unitRateINR":28609,"date":"31-Jan-2025","totalValueINR":"45774400","totalValueInUsd":"530845.7","indian_port":"Ahmedabad Air","hs_no":"29252990","bill_no":"7757212","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Import","activeIngredients":"FLUVOXAMINE MALEATE","year":"2021","qtr":"Q2","strtotime":1617215400,"product":"REIMPORT OF PHARMACEUTICAL RAW MATERIAL(ALLOPATHIC)FOR PHARMACEUTICAL INDUSTRY FLUVOXAMINE MALEATE USPBATCH NO.MDD230101","address":"806\/807,8TH FLOOR, 215 ATRIUM,CHAKALA, ANDHERI KURLA RD.","city":"ANDHERI (E) MUMBAI, MAHARASHTRA.","supplier":"PHARMEVO (PRIVATE) LIMITED.,","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"COHANCE LIFESCIENCES","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"260","totalValueFC":"19212.1","currency":"USD","unitRateINR":"19071","date":"01-Apr-2021","totalValueINR":"1430325","totalValueInUsd":"19212.1","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3398119","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KARACHI -","supplierAddress":"","customerAddress":"806\/807,8TH FLOOR, 215 ATRIUM,CHAKALA, ANDHERI KURLA RD."},{"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"}]
02-Jan-2021
31-Jan-2025
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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

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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

Looking for 61718-82-9 / Fluvoxamine API manufacturers, exporters & distributors?

Fluvoxamine manufacturers, exporters & distributors 1

44

PharmaCompass offers a list of Fluvoxamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fluvoxamine manufacturer or Fluvoxamine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluvoxamine manufacturer or Fluvoxamine supplier.

PharmaCompass also assists you with knowing the Fluvoxamine API Price utilized in the formulation of products. Fluvoxamine API Price is not always fixed or binding as the Fluvoxamine Price is obtained through a variety of data sources. The Fluvoxamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fluvoxamine

Synonyms

Luvox, 61718-82-9, Fevarin, Faverin, Luvox cr, Du23000

Cas Number

61718-82-9

Unique Ingredient Identifier (UNII)

5LGN83G74V

About Fluvoxamine

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

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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