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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
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)
| Molecular Weight | 883.1 g/mol |
|---|---|
| Molecular Formula | C46H54N6O8S2 |
| 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 Ų |
| 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 |
| 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 |
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.)
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 20639
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
DOSAGE - TABLET;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 22047
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PharmaCompass offers a list of Quetiapine Hemifumarate 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 Hemifumarate manufacturer or Quetiapine Hemifumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quetiapine Hemifumarate manufacturer or Quetiapine Hemifumarate supplier.
PharmaCompass also assists you with knowing the Quetiapine Hemifumarate API Price utilized in the formulation of products. Quetiapine Hemifumarate API Price is not always fixed or binding as the Quetiapine Hemifumarate Price is obtained through a variety of data sources. The Quetiapine Hemifumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Quetiapine fumarate [USAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quetiapine fumarate [USAN], including repackagers and relabelers. The FDA regulates Quetiapine fumarate [USAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quetiapine fumarate [USAN] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Quetiapine fumarate [USAN] supplier is an individual or a company that provides Quetiapine fumarate [USAN] active pharmaceutical ingredient (API) or Quetiapine fumarate [USAN] finished formulations upon request. The Quetiapine fumarate [USAN] suppliers may include Quetiapine fumarate [USAN] API manufacturers, exporters, distributors and traders.
click here to find a list of Quetiapine fumarate [USAN] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quetiapine fumarate [USAN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Quetiapine fumarate [USAN] active pharmaceutical ingredient (API) in detail. Different forms of Quetiapine fumarate [USAN] DMFs exist exist since differing nations have different regulations, such as Quetiapine fumarate [USAN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quetiapine fumarate [USAN] DMF submitted to regulatory agencies in the US is known as a USDMF. Quetiapine fumarate [USAN] USDMF includes data on Quetiapine fumarate [USAN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quetiapine fumarate [USAN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 [USAN] Drug Master File in Japan (Quetiapine fumarate [USAN] JDMF) empowers Quetiapine fumarate [USAN] 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 [USAN] JDMF during the approval evaluation for pharmaceutical products. At the time of Quetiapine fumarate [USAN] JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 [USAN] Drug Master File in Korea (Quetiapine fumarate [USAN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quetiapine fumarate [USAN]. The MFDS reviews the Quetiapine fumarate [USAN] KDMF as part of the drug registration process and uses the information provided in the Quetiapine fumarate [USAN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Quetiapine fumarate [USAN] 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 [USAN] API can apply through the Korea Drug Master File (KDMF).
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A Quetiapine fumarate [USAN] CEP of the European Pharmacopoeia monograph is often referred to as a Quetiapine fumarate [USAN] Certificate of Suitability (COS). The purpose of a Quetiapine fumarate [USAN] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quetiapine fumarate [USAN] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quetiapine fumarate [USAN] to their clients by showing that a Quetiapine fumarate [USAN] CEP has been issued for it. The manufacturer submits a Quetiapine fumarate [USAN] CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quetiapine fumarate [USAN] CEP holder for the record. Additionally, the data presented in the Quetiapine fumarate [USAN] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quetiapine fumarate [USAN] DMF.
A Quetiapine fumarate [USAN] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quetiapine fumarate [USAN] CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Quetiapine fumarate [USAN] written confirmation (Quetiapine fumarate [USAN] WC) is an official document issued by a regulatory agency to a Quetiapine fumarate [USAN] manufacturer, verifying that the manufacturing facility of a Quetiapine fumarate [USAN] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Quetiapine fumarate [USAN] APIs or Quetiapine fumarate [USAN] finished pharmaceutical products to another nation, regulatory agencies frequently require a Quetiapine fumarate [USAN] WC (written confirmation) as part of the regulatory process.
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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 [USAN] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quetiapine fumarate [USAN] API and other APIs are published in this directory by the FDA.
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 [USAN] 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.
The NDC directory also contains data on finished compounded human drug products that contain Quetiapine fumarate [USAN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quetiapine fumarate [USAN] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quetiapine fumarate [USAN] suppliers with NDC on PharmaCompass.
Quetiapine fumarate [USAN] 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 [USAN] 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 [USAN] GMP manufacturer or Quetiapine fumarate [USAN] GMP API supplier for your needs.
A Quetiapine fumarate [USAN] CoA (Certificate of Analysis) is a formal document that attests to Quetiapine fumarate [USAN]'s compliance with Quetiapine fumarate [USAN] specifications and serves as a tool for batch-level quality control.
Quetiapine fumarate [USAN] CoA mostly includes findings from lab analyses of a specific batch. For each Quetiapine fumarate [USAN] 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 [USAN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Quetiapine fumarate [USAN] EP), Quetiapine fumarate [USAN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quetiapine fumarate [USAN] USP).
