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Molecular Weight | 326.8 g/mol |
---|---|
Molecular Formula | C18H19ClN4 |
XLogP3 | 3.2 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 1 |
Exact Mass | 326.1298243 g/mol |
Monoisotopic Mass | 326.1298243 g/mol |
Topological Polar Surface Area | 30.9 A^2 |
Heavy Atom Count | 23 |
Formal Charge | 0 |
Complexity | 584 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 6 | |
---|---|
Drug Name | Clozapine |
PubMed Health | Clozapine (By mouth) |
Drug Classes | Antipsychotic |
Drug Label | VERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c... |
Active Ingredient | Clozapine |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 100mg; 25mg; 50mg; 12.5mg |
Market Status | Prescription |
Company | Ivax Sub Teva Pharms; Sun Pharm Inds; Mylan |
2 of 6 | |
---|---|
Drug Name | Clozaril |
PubMed Health | Clozapine (By mouth) |
Drug Classes | Antipsychotic |
Drug Label | CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg... |
Active Ingredient | Clozapine |
Dosage Form | Tablet |
Route | Oral |
Strength | 100mg; 25mg |
Market Status | Prescription |
Company | Novartis |
3 of 6 | |
---|---|
Drug Name | Fazaclo odt |
Active Ingredient | Clozapine |
Dosage Form | Tablet, orally disintegrating |
Route | Oral |
Strength | 200mg; 100mg; 25mg; 150mg; 12.5mg |
Market Status | Prescription |
Company | Jazz Pharms Iii |
4 of 6 | |
---|---|
Drug Name | Clozapine |
PubMed Health | Clozapine (By mouth) |
Drug Classes | Antipsychotic |
Drug Label | VERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c... |
Active Ingredient | Clozapine |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 100mg; 25mg; 50mg; 12.5mg |
Market Status | Prescription |
Company | Ivax Sub Teva Pharms; Sun Pharm Inds; Mylan |
5 of 6 | |
---|---|
Drug Name | Clozaril |
PubMed Health | Clozapine (By mouth) |
Drug Classes | Antipsychotic |
Drug Label | CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg... |
Active Ingredient | Clozapine |
Dosage Form | Tablet |
Route | Oral |
Strength | 100mg; 25mg |
Market Status | Prescription |
Company | Novartis |
6 of 6 | |
---|---|
Drug Name | Fazaclo odt |
Active Ingredient | Clozapine |
Dosage Form | Tablet, orally disintegrating |
Route | Oral |
Strength | 200mg; 100mg; 25mg; 150mg; 12.5mg |
Market Status | Prescription |
Company | Jazz Pharms Iii |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status : Active
Type : II
Certificate Number : R0-CEP 2018-192 - Rev 01
Issue Date : 2021-02-12
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1010
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2015-01-26
DMF Number : 10534
Submission : 1993-10-21
Status : Active
Type : II
Certificate Number : R1-CEP 2008-151 - Rev 00
Issue Date : 2015-07-13
Type : Chemical
Substance Number : 1191
Status : Valid
Registration Number : 301MF10021
Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona) Spain
Initial Date of Registration : 2019-06-25
Latest Date of Registration :
NDC Package Code : 53296-0033
Start Marketing Date : 2010-03-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2020-05-04
Registration Number : 20180903-209-J-157(2)
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-29
Pay. Date : 2013-09-25
DMF Number : 25182
Submission : 2011-08-03
Status : Active
Type : II
Certificate Number : R1-CEP 2012-006 - Rev 00
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1191
Status : Valid
NDC Package Code : 64374-004
Start Marketing Date : 2016-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36869
Submission : 2022-03-23
Status : Active
Type : II
Certificate Number : CEP 2022-328 - Rev 00
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19822
Submission : 2006-10-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11195
Submission : 1994-11-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-26
Pay. Date : 2022-12-12
DMF Number : 36645
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2023-444 - Rev 00
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37540
Submission : 2023-02-01
Status : Active
Type : II
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PharmaCompass offers a list of Clozapine 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 Clozapine manufacturer or Clozapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clozapine manufacturer or Clozapine supplier.
PharmaCompass also assists you with knowing the Clozapine API Price utilized in the formulation of products. Clozapine API Price is not always fixed or binding as the Clozapine Price is obtained through a variety of data sources. The Clozapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine, including repackagers and relabelers. The FDA regulates 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine supplier is an individual or a company that provides 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine active pharmaceutical ingredient (API) or 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine finished formulations upon request. The 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers may include 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine API manufacturers, exporters, distributors and traders.
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A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine DMF (Drug Master File) is a document detailing the whole manufacturing process of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine active pharmaceutical ingredient (API) in detail. Different forms of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine DMFs exist exist since differing nations have different regulations, such as 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine DMF submitted to regulatory agencies in the US is known as a USDMF. 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine USDMF includes data on 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Drug Master File in Japan (8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine JDMF) empowers 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine JDMF during the approval evaluation for pharmaceutical products. At the time of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Drug Master File in Korea (8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine. The MFDS reviews the 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine KDMF as part of the drug registration process and uses the information provided in the 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine KDMF to evaluate the safety and efficacy of the drug.
After submitting a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with KDMF on PharmaCompass.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP of the European Pharmacopoeia monograph is often referred to as a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Certificate of Suitability (COS). The purpose of a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine to their clients by showing that a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP has been issued for it. The manufacturer submits a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP (COS) as part of the market authorization procedure, and it takes on the role of a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP holder for the record. Additionally, the data presented in the 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine DMF.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine written confirmation (8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine WC) is an official document issued by a regulatory agency to a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine manufacturer, verifying that the manufacturing facility of a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine APIs or 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine finished pharmaceutical products to another nation, regulatory agencies frequently require a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with NDC on PharmaCompass.
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine GMP manufacturer or 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine GMP API supplier for your needs.
A 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CoA (Certificate of Analysis) is a formal document that attests to 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine's compliance with 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine specifications and serves as a tool for batch-level quality control.
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CoA mostly includes findings from lab analyses of a specific batch. For each 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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.
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine may be tested according to a variety of international standards, such as European Pharmacopoeia (8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine EP), 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine USP).