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Synopsis

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359EXCIPIENTS BY APPLICATIONS

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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 SUPPLIERS

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01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Flag U.S.A
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
LGM Pharma CB

02

Cohance Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Organic Process R&D
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Cohance

03

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU arrow-down AUDIT
HRV Global Life Sciences

04

Medichem S.A

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Flag Spain
Digital Content Digital Content
USDMF arrow-down CEP/COS arrow-down JDMF arrow-down EU-WC NDC arrow-down KDMF arrow-down VMF Others AUDIT
Medichem

05

Shouguang Fukang Pharmaceutical Co...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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Shouguang Fukang Pharmaceutical Co...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

06

Global Calcium

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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Global Calcium

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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07

Wuhan Shiji Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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Wuhan Shiji Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

08

SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

09

Aurore Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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Aurore Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
blank

10

Mankind Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

OPRD USA
Not Confirmed
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Mankind Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OPRD USA
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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API Reference Price

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02-Jan-2021
29-Jan-2025
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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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Direct Compression

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Looking for / Clozapine API manufacturers, exporters & distributors?

Clozapine manufacturers, exporters & distributors 1

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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.

API | Excipient name

Clozapine

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Manufacturers

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.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Suppliers

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.

click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine USDMF

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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8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 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.

click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with JDMF on PharmaCompass.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine KDMF

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.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CEP

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.

click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with CEP (COS) on PharmaCompass.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine WC

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.

click here to find a list of 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine suppliers with Written Confirmation (WC) on PharmaCompass.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine 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 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine CoA

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).

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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