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Chemistry

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Also known as:
Molecular Formula
C18H19ClN4
Molecular Weight
326.8  g/mol
InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N

Clozapine
1 2D Structure

Clozapine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-chloro-6-(4-methylpiperazin-1-yl)-5H-benzo[b][1,4]benzodiazepine
2.1.2 InChI
InChI=1S/C18H19ClN4/c1-22-8-10-23(11-9-22)18-14-4-2-3-5-15(14)20-16-7-6-13(19)12-17(16)21-18/h2-7,12,21H,8-11H2,1H3
2.1.3 InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.1.5 Isomeric SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.2 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 326.8 g/mol
Molecular Formula C18H19ClN4
XLogP33.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count1
Exact Mass326.1298243 g/mol
Monoisotopic Mass326.1298243 g/mol
Topological Polar Surface Area30.9 A^2
Heavy Atom Count23
Formal Charge0
Complexity584
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, 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 IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

2 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (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 IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

4 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, 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 IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

5 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (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 IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

API Reference Price

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12-Jan-2022
31-Jul-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - SUSPENSION;ORAL - 50MG/ML

USFDA APPLICATION NUMBER - 203479

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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ABOUT THIS PAGE

Looking for / Clozapine API manufacturers, exporters & distributors?

Clozapine manufacturers, exporters & distributors 1

51

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.

API | Excipient name

Clozapine

Clozapine Manufacturers

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

Clozapine Suppliers

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

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

Clozapine USDMF

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

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

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

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

Clozapine KDMF

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

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

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

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

Clozapine CEP

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

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

Clozapine WC

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

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

Clozapine 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 Clozapine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Clozapine GMP

Clozapine 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 Clozapine 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 Clozapine GMP manufacturer or Clozapine GMP API supplier for your needs.

Clozapine CoA

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

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

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