List of Europe Written Confirmation (EU WC) issued for Quetiapine Fumarate Active Pharmaceutical Ingredient listed on PharmaCompass.com

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

116 API Suppliers, 58 USDMF, 40 CEP/COS, 9 JDMF, 36 EU WC, 33 KDMF, 32 NDC API, 71 Listed Suppliers, $ API Reference Price

116 API Suppliers
58 USDMF
40 CEP/COS
9 JDMF
36 EU WC
33 KDMF
32 NDC API
71 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

32 Intermediates Suppliers

32 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1365 FDF Dossiers, 198 FDA Orange Book, 700 Europe, 145 Canada, 69 Australia, 109 South Africa, 144 Listed Dossiers

1365 FDF Dossiers
198 FDA Orange Book
700 Europe
145 Canada
69 Australia
109 South Africa
144 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

drugProductComposition
TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 200MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 300MG BASE
TABLET;ORAL - EQ 400MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 11 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

relatedExcipients
4 SPI Pharma
2 Seqens
4 DKSH
2 Jai Radhe Sales
11 Boai NKY Pharmaceuticals Ltd
13 Gangwal Healthcare
6 Nanjing Well Pharmaceutical
1 ACG Worldwide
9 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
26 BASF
2 Clariant
11 Corel Pharma Chem
7 DFE Pharma
2 Finar
13 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
38 Kerry
4 Kima Chemical
6 Lonza Capsugel
13 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
4 Pharmatrans-Sanaq
5 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
18 Roquette
14 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
12 Sigachi Industries
3 The Dow Chemical Company
4 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 42 Disintegrants & Superdisintegrants, 41 Direct Compression, 35 Controlled & Modified Release, 31 Solubilizers, 28 Thickeners and Stabilizers, 27 Granulation, 20 Co-Processed Excipients, 18 Parenteral, 18 Film Formers & Plasticizers, 17 Topical, 16 Lubricants & Glidants, 10 Emulsifying Agents, 9 Chewable & Orodispersible Aids, 9 Taste Masking, 7 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 541 Finished Drug Prices, 13 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
541 Finished Drug Prices
13 Annual Reports

MARKET PLACE

12 APIs, 10 FDF Dossiers

marketPlace
12 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 Health Canada Patents

patents
14 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 4 USP , 5 JP , 29 Others

otherSolutions
2 EDQM
4 USP
5 JP
29 Others

ANALYTICAL

2 BioAnalytical Methods

otherMethods
2 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

116

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 106

MARKET PLACE

API

FDF

32INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

1365

FDF Dossiers

198

FDA Orange Book

700

Europe

145

Canada

Australia

109

South Africa

144

Listed Dossiers

13DRUGS 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)

290,097,692

Annual Reports (USD Million)

3,350

Finished Drug Prices

283 RELATED EXCIPIENT COMPANIES

486EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: Quetiapine hemifumarate, 111974-72-2, Seroquel, Ici-204636, Seroquel xr, Ici 204,636

Molecular Formula

C₄₆H₅₄N₆O₈S₂

Molecular Weight

883.1 g/mol

InChI Key

ZTHJULTYCAQOIJ-WXXKFALUSA-N

FDA UNII

2S3PL1B6UJ

A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.

1 2D Structure

Quetiapine Hemifumarate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[2-(4-benzo[b][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol;(E)-but-2-enedioic acid

2.1.2 InChI

InChI=1S/2C21H25N3O2S.C4H4O4/c2*25-14-16-26-15-13-23-9-11-24(12-10-23)21-17-5-1-3-7-19(17)27-20-8-4-2-6-18(20)22-21;5-3(6)1-2-4(7)8/h2*1-8,25H,9-16H2;1-2H,(H,5,6)(H,7,8)/b;;2-1+

2.1.3 InChI Key

ZTHJULTYCAQOIJ-WXXKFALUSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C(=CC(=O)O)C(=O)O

2.1.5 Isomeric SMILES

C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C(=C/C(=O)O)\C(=O)O

2.2 Other Identifiers

2.2.1 UNII

2S3PL1B6UJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(2-(4-dibenzo(b,f)(1,4)thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol

2. Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-, (e)-2-butenedioate (2:1) (salt)

3. Ici 204,636

4. Ici 204636

5. Ici-204636

6. Ici204636

7. Quetiapine

8. Seroquel

2.3.2 Depositor-Supplied Synonyms

1. Quetiapine Hemifumarate

2. 111974-72-2

3. Seroquel

4. Ici-204636

5. Seroquel Xr

6. Ici 204,636

7. Quetiapine Fumarate [usan]

8. Zd5077

9. Utapine

10. Zm 204,636

11. Zm 204636

12. Quetiapine (as Fumarate)

13. Quetiapine Hemifumarate Salt

14. 2s3pl1b6uj

15. Quetiapine Fumarate (seroquel)

16. Fk947e

17. Fk-947e

18. Ici 204636

19. Zd-5077

20. Zm-204636

21. Chebi:8708

22. Fk949e

23. (2e)-but-2-enedioic Acid; Bis(2-[2-(4-{2-thia-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(15),3,5,7,9,11,13-heptaen-10-yl}piperazin-1-yl)ethoxy]ethan-1-ol)

24. 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)ethanol Fumarate (2:1) (salt)

25. Unii-2s3pl1b6uj

26. Seroquel (tn)

27. 2-(2-(4-dibenzo(b,f)(1,4)thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol

28. Mfcd03423782

29. Quetiapine Fumarate Salt

30. Ethanol, 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-, (2e)-2-butenedioate (2:1)

31. D00458

32. Quetiapine Fumarate Solution

33. 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Hemifumarate

34. Dsstox_cid_24201

35. Dsstox_rid_80114

36. Dsstox_gsid_44201

37. Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-, (e)-2-butenedioate (2:1) (salt)

38. Schembl122596

39. Schembl390694

40. Chembl3188993

41. Dtxsid3044201

42. Quetiapine For System Suitability

43. Quetiapine Fumarate [jan]

44. Quetiapine Fumarate (jp17/usp)

45. Hms2089g04

46. Hms3713m10

47. Hms3884a10

48. Quetiapine Fumarate [vandf]

49. Bcp04154

50. Quetiapine Fumarate [mart.]

51. Quetiapine Hemifumarate [mi]

52. Tox21_302366

53. Quetiapine Fumarate [usp-rs]

54. Quetiapine Fumarate [who-dd]

55. S1763

56. Akos015855887

57. Ac-4236

58. Ccg-220464

59. Ks-1099

60. C21h25n3o2s.0.5c4h4o4

61. Ncgc00255945-01

62. Quetiapine Fumarate [orange Book]

63. As-12050

64. Quetiapine Fumarate [ep Monograph]

65. Quetiapine Fumarate [usp Monograph]

66. Cas-111974-72-2

67. Sw220283-1

68. Quetiapine Hemifumarate Salt, >=98% (hplc)

69. 974q697

70. J-002679

71. Q-201653

72. Q27108136

73. Quetiapine Fumarate 1.0 Mg/ml In Methanol (as Free Base)

74. Quetiapine Fumarate, European Pharmacopoeia (ep) Reference Standard

75. 2-[2-(4-dibenzo[b,f][1,4]thiazepin- 11-yl-1-piperazinyl)ethoxy]ethanol Hemifumarate

76. Bis(2-(2-(4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethan-1-ol) Fumarate

77. Quetiapine For System Suitability, European Pharmacopoeia (ep) Reference Standard

78. Quetiapine Fumarate, Pharmaceutical Secondary Standard; Certified Reference Material

79. 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)ethanol Fumarate (2:1)

80. Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-, (e)-2-butenedioate (2:1)

81. Quetiapine Fumarate Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

82. Quetiapine Fumarate, United States Pharmacopeia (usp) Reference Standard, Monograph Mol Wt. 883.09 ((c21h25n3o2s)2 ?? C4h4o4)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₄₆H₅₄N₆O₈S₂
Molecular Weight	883.1 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	14
Rotatable Bond Count	14
Exact Mass	882.34445505 g/mol
Monoisotopic Mass	882.34445505 g/mol
Topological Polar Surface Area	222 Å²
Heavy Atom Count	62
Formal Charge	0
Complexity	615
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Quetiapine fumarate
Drug Label	Quetiapine is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets...
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet, extended release; Tablet
Route	oral; Oral
Strength	eq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base; eq 25mg base
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Apotex; Accord Hlthcare; Alkem Labs; Handa Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Sun Pharma Global; Roxane; Actavis Grp Ptc; Teva Pharms; Jubilant Generics; Dr Reddys Labs

2 of 6
Drug Name	Seroquel
PubMed Health	Quetiapine (By mouth)
Drug Classes	Antipsychotic
Drug Label	SEROQUEL (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It...
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 200mg base; eq 300mg base; eq 400mg base; eq 25mg base
Market Status	Prescription
Company	Astrazeneca

3 of 6
Drug Name	Seroquel xr
Drug Label	SEROQUEL XR (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt)....
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet, extended release
Route	oral; Oral
Strength	200mg; eq 50mg base; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base
Market Status	Prescription
Company	Astrazeneca

4 of 6
Drug Name	Quetiapine fumarate
Drug Label	Quetiapine is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets...
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet, extended release; Tablet
Route	oral; Oral
Strength	eq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base; eq 25mg base
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Apotex; Accord Hlthcare; Alkem Labs; Handa Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Sun Pharma Global; Roxane; Actavis Grp Ptc; Teva Pharms; Jubilant Generics; Dr Reddys Labs

5 of 6
Drug Name	Seroquel
PubMed Health	Quetiapine (By mouth)
Drug Classes	Antipsychotic
Drug Label	SEROQUEL (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It...
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet
Route	Oral
Strength	eq 100mg base; eq 50mg base; eq 200mg base; eq 300mg base; eq 400mg base; eq 25mg base
Market Status	Prescription
Company	Astrazeneca

6 of 6
Drug Name	Seroquel xr
Drug Label	SEROQUEL XR (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt)....
Active Ingredient	Quetiapine fumarate
Dosage Form	Tablet, extended release
Route	oral; Oral
Strength	200mg; eq 50mg base; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base
Market Status	Prescription
Company	Astrazeneca

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antipsychotic Agents

Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)

Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Atypical Antipsychotic [EPC]

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Quetiapine Fumarate "alternative Process"

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Medichem Sa

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Megafine Pharma P Ltd

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Ind Swift Laboratories Ltd

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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DOSAGE - TABLET;ORAL - EQ 100MG BASE