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    Chemistry

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    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
    Quetiapine Hemifumarate
    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 Weight 883.1 g/mol
    Molecular Formula C46H54N6O8S2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count14
    Exact Mass882.34445505 g/mol
    Monoisotopic Mass882.34445505 g/mol
    Topological Polar Surface Area222 Ų
    Heavy Atom Count62
    Formal Charge0
    Complexity615
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameQuetiapine fumarate
    Drug LabelQuetiapine 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 IngredientQuetiapine fumarate
    Dosage FormTablet, extended release; Tablet
    Routeoral; Oral
    Strengtheq 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 StatusTentative Approval; Prescription
    CompanyMylan 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 NameSeroquel
    PubMed HealthQuetiapine (By mouth)
    Drug ClassesAntipsychotic
    Drug LabelSEROQUEL (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 IngredientQuetiapine fumarate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 200mg base; eq 300mg base; eq 400mg base; eq 25mg base
    Market StatusPrescription
    CompanyAstrazeneca

    3 of 6  
    Drug NameSeroquel xr
    Drug LabelSEROQUEL 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 IngredientQuetiapine fumarate
    Dosage FormTablet, extended release
    Routeoral; Oral
    Strength200mg; eq 50mg base; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base
    Market StatusPrescription
    CompanyAstrazeneca

    4 of 6  
    Drug NameQuetiapine fumarate
    Drug LabelQuetiapine 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 IngredientQuetiapine fumarate
    Dosage FormTablet, extended release; Tablet
    Routeoral; Oral
    Strengtheq 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 StatusTentative Approval; Prescription
    CompanyMylan 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 NameSeroquel
    PubMed HealthQuetiapine (By mouth)
    Drug ClassesAntipsychotic
    Drug LabelSEROQUEL (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 IngredientQuetiapine fumarate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 200mg base; eq 300mg base; eq 400mg base; eq 25mg base
    Market StatusPrescription
    CompanyAstrazeneca

    6 of 6  
    Drug NameSeroquel xr
    Drug LabelSEROQUEL 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 IngredientQuetiapine fumarate
    Dosage FormTablet, extended release
    Routeoral; Oral
    Strength200mg; eq 50mg base; eq 150mg base; 400mg; 300mg; eq 200mg base; 50mg; eq 300mg base; eq 400mg base
    Market StatusPrescription
    CompanyAstrazeneca

    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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EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"131.50","actualQuantity":"131.5","unit":"KGS","unitRateFc":"115","totalValueFC":"15298.9","currency":"USD","unitRateINR":"9683","date":"25-Oct-2023","totalValueINR":"1273314.5","totalValueInUsd":"15298.9","indian_port":"JNPT","hs_no":"29349990","bill_no":"8452817","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN, , SpainSDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698172200,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"165.00","actualQuantity":"165","unit":"KGS","unitRateFc":"115","totalValueFC":"19196.3","currency":"USD","unitRateINR":"9683","date":"25-Oct-2023","totalValueINR":"1597695","totalValueInUsd":"19196.3","indian_port":"JNPT","hs_no":"29349990","bill_no":"8452817","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN, , SpainSDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698172200,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"238.00","actualQuantity":"238","unit":"KGS","unitRateFc":"115","totalValueFC":"27689.2","currency":"USD","unitRateINR":"9683","date":"25-Oct-2023","totalValueINR":"2304554","totalValueInUsd":"27689.2","indian_port":"JNPT","hs_no":"29349990","bill_no":"8452817","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN, , SpainSDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704306600,"product":"QUETI-VIIA REF (QUETIAPINE INTERMEDIATE) (BATCH NO- L109272)(SAMPLES FOR RESEARCH & DEVELOPMENT PURPOSE)(FOC)","address":"SCF.287, MOTOR MARKET,","city":"CHANDIGARH.","supplier":"ORION CORPORATION","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"SAURAV CHEMICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"2","totalValueFC":"1.1","currency":"EUR","unitRateINR":"184.7","date":"04-Jan-2024","totalValueINR":"92.35","totalValueInUsd":"1.1","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"9531188","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"ORIONINTIE 102200 ESPOO, FINLAND","customerAddress":"SCF.287, MOTOR MARKET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706725800,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"342.00","actualQuantity":"342","unit":"KGS","unitRateFc":"115","totalValueFC":"39863.8","currency":"USD","unitRateINR":"9671.5","date":"01-Feb-2024","totalValueINR":"3307653","totalValueInUsd":"39863.8","indian_port":"JNPT","hs_no":"29349990","bill_no":"9931241","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN,SDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706725800,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"459.00","actualQuantity":"459","unit":"KGS","unitRateFc":"115","totalValueFC":"53501.5","currency":"USD","unitRateINR":"9671.5","date":"01-Feb-2024","totalValueINR":"4439218.5","totalValueInUsd":"53501.5","indian_port":"JNPT","hs_no":"29349990","bill_no":"9931241","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN,SDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706725800,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"115","totalValueFC":"64108.5","currency":"USD","unitRateINR":"9671.5","date":"01-Feb-2024","totalValueINR":"5319325","totalValueInUsd":"64108.5","indian_port":"JNPT","hs_no":"29349990","bill_no":"9931241","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT JOAN DESPI, BARCELONA SPAIN,SDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744741800,"product":"QUETIAPINE FUMARATE PH.EUR","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO LABS LIMITED UNIT-IX,","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"1002.71","actualQuantity":"1002.71","unit":"KGS","unitRateFc":"75.1","totalValueFC":"76138.8","currency":"USD","unitRateINR":"6500","date":"16-Apr-2025","totalValueINR":"6517615","totalValueInUsd":"76138.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29349990","bill_no":"9511459","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETEO INFRASTRUCTURE SEZ LTD, PLOT NO:2, N.NARSAPURAM (V) SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"}]
    06-Jan-2021
    24-Apr-2025
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    DOSAGE - TABLET;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 20639

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20639

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    DOSAGE - TABLET;ORAL - EQ 200MG BASE

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    USFDA APPLICATION NUMBER - 20639

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

    USFDA APPLICATION NUMBER - 22047

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE

    USFDA APPLICATION NUMBER - 22047

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 22047

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    ABOUT THIS PAGE

    Looking for 111974-72-2 / Quetiapine Fumarate API manufacturers, exporters & distributors?

    Quetiapine Fumarate manufacturers, exporters & distributors 1

    88

    PharmaCompass offers a list of Quetiapine Fumarate 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 Quetiapine Fumarate manufacturer or Quetiapine Fumarate supplier for your needs.

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

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

    API | Excipient name

    Quetiapine Fumarate

    Synonyms

    Quetiapine hemifumarate, 111974-72-2, Seroquel, Ici-204636, Seroquel xr, Ici 204,636

    Cas Number

    111974-72-2

    Unique Ingredient Identifier (UNII)

    2S3PL1B6UJ

    About Quetiapine Fumarate

    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.

    Quetiapine Hemifumarate Manufacturers

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

    Quetiapine Hemifumarate Suppliers

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

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

    Quetiapine Hemifumarate USDMF

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

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

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

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

    Quetiapine Hemifumarate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Quetiapine Hemifumarate Drug Master File in Korea (Quetiapine Hemifumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quetiapine Hemifumarate. The MFDS reviews the Quetiapine Hemifumarate KDMF as part of the drug registration process and uses the information provided in the Quetiapine Hemifumarate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Quetiapine Hemifumarate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Quetiapine Hemifumarate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Quetiapine Hemifumarate suppliers with KDMF on PharmaCompass.

    Quetiapine Hemifumarate CEP

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

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

    Quetiapine Hemifumarate WC

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

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

    Quetiapine Hemifumarate 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 Quetiapine Hemifumarate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Quetiapine Hemifumarate GMP

    Quetiapine Hemifumarate 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 Quetiapine Hemifumarate 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 Quetiapine Hemifumarate GMP manufacturer or Quetiapine Hemifumarate GMP API supplier for your needs.

    Quetiapine Hemifumarate CoA

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

    Quetiapine Hemifumarate CoA mostly includes findings from lab analyses of a specific batch. For each Quetiapine Hemifumarate 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.

    Quetiapine Hemifumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Quetiapine Hemifumarate EP), Quetiapine Hemifumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quetiapine Hemifumarate 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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