Drug Product Composition data of MolPort-001-728-041 on PharmaCompass.com

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

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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

  • fda
  • EDQM
  • WHO-GMP

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

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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.

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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

  • fda
  • EDQM
  • WHO-GMP

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

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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

26th North American ISSX
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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26th North American ISSX
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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06

Aurore Life Sciences

India

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

26th North American ISSX
Not Confirmed
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Aurore Life Sciences

India

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

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26th North American ISSX
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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07

SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

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

26th North American ISSX
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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26th North American ISSX
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

08

Sandoz B2B

Switzerland

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

26th North American ISSX
Not Confirmed
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Sandoz B2B

Switzerland

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

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26th North American ISSX
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

Global Calcium

India

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

26th North American ISSX
Not Confirmed
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Global Calcium

India

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

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26th North American ISSX
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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10

Wuhan Shiji Pharmaceutical

China

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

26th North American ISSX
Not Confirmed
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Wuhan Shiji Pharmaceutical

China

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

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26th North American ISSX
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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EU WC

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01

  • 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

Clozapine BP/USP/EP

Date of Issue : 2022-08-25

Valid Till : 2025-07-02

Written Confirmation Number : WC-0195

Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...

Cohance

02

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Clozapine Ph.Eur

Date of Issue : 2022-09-19

Valid Till : 2025-07-02

Written Confirmation Number : WC-0119

Address of the Firm : Plot No. 35, 36, 38, 39,40,49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal- Malk...

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03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Clozapine EP

Date of Issue : 2021-10-13

Valid Till : 2022-07-02

Written Confirmation Number : WC-0119A10

Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50, & 51, Phase IV, IDA, Jeedimetla, Medchal-Ma...

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Clozapine IP/EP/USP

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0104

Address of the Firm : #125 & 126, Sipcot Industrial Complex, Hosur-635 126, Tamilnadu

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05

Viatris

U.S.A
26th North American ISSX
Not Confirmed
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Viatris

U.S.A
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26th North American ISSX
Not Confirmed

Clozapine USP/EP

Date of Issue : 2019-06-03

Valid Till : 2022-06-02

Written Confirmation Number : WC-0015

Address of the Firm : Unit VIII, G Chodevaram (V), Pusapatirega (Mandal), Vizianagaram Dist.,-535204, ...

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API Reference Price

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MAHARASHTRA","supplier":"AASTRID INTERNATIONAL PVT. LTD","supplierCountry":"INDIA","foreign_port":"BEIRUT","customer":"MLLT","customerCountry":"LEBANON","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"94.5","totalValueFC":"18351.3","currency":"USD","unitRateINR":6805.3318500000005,"date":"30-Aug-2021","totalValueINR":"1361066.37","totalValueInUsd":"18351.3","indian_port":"BOMBAY AIR","hs_no":"29335990","bill_no":"4223253","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"LEBANON","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"247 & 248, UDYOG BHAVAN, SONAWALAROAD, GOREGAON EAST,, MUMBAI. MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1633285800,"product":"BULK DRUGS : CLOZAPINE USP","address":"112,, MARINE CHAMBERS,11, NEW MARINE LINES,","city":"MUMBAI. 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04-Jan-2021
26-Aug-2024
KGS
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Average Price (USD/KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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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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