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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":"458.00","actualQuantity":"458","unit":"KGS","unitRateFc":"115","totalValueFC":"53212.1","currency":"USD","unitRateINR":"9671.5","date":"05-Dec-2023","totalValueINR":"4429547","totalValueInUsd":"53212.1","indian_port":"JNPT","hs_no":"29349990","bill_no":"9075322","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":1706725800,"product":"QUETIAPINE FUMARATE EP\/BP\/IP\/USP\/PH. EUR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","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":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"}]
02-Jan-2021
31-Mar-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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USFDA APPLICATION NUMBER - 20639

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DOSAGE - TABLET;ORAL - EQ 25MG BASE

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USFDA APPLICATION NUMBER - 20639

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DOSAGE - TABLET;ORAL - EQ 400MG BASE

USFDA APPLICATION NUMBER - 20639

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DOSAGE - TABLET;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 20639

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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

USFDA APPLICATION NUMBER - 22047

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

USFDA APPLICATION NUMBER - 22047

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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

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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 Fumarate Manufacturers

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

Quetiapine Fumarate Suppliers

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

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

Quetiapine Fumarate USDMF

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

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

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

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

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

After submitting a Quetiapine Fumarate 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 Fumarate API can apply through the Korea Drug Master File (KDMF).

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

Quetiapine Fumarate CEP

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

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

Quetiapine Fumarate WC

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

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

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

Finished drug products

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

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

Quetiapine Fumarate GMP

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

Quetiapine Fumarate CoA

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

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