Clozapine | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Clozapine
South Africa

Evonik

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Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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xyz-pharma-m-2024-10-07

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-10-07

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Clozapine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 9 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 9 NDC API, 14 Listed Suppliers, $ API Reference Price

26 API Suppliers
15 USDMF
9 CEP/COS
1 JDMF
5 EU WC
3 KDMF
9 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

198 FDF Dossiers, 55 FDA Orange Book, 60 Europe, 12 Canada, 36 Australia, 9 South Africa, 26 Listed Dossiers

198 FDF Dossiers
55 FDA Orange Book
60 Europe
12 Canada
36 Australia
9 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, SUSPENSION;ORAL - 50MG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG
TABLET;ORAL - 200MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
SUSPENSION;ORAL - 50MG/ML
TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 28 Kerry, 13 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 41 Direct Compression, 24 Disintegrants & Superdisintegrants, 24 Taste Masking, 23 Lubricants & Glidants, 22 Granulation, 21 Co-Processed Excipients, 21 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 14 Controlled & Modified Release, 12 Parenteral, 8 Solubilizers, 5 API Stability Enhancers, 5 Topical, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

88 Fillers, Diluents & Binders
41 Direct Compression
24 Disintegrants & Superdisintegrants
24 Taste Masking
23 Lubricants & Glidants
22 Granulation
21 Co-Processed Excipients
21 Thickeners and Stabilizers
20 Chewable & Orodispersible Aids
17 Coating Systems & Additives
16 Film Formers & Plasticizers
14 Controlled & Modified Release
12 Parenteral
8 Solubilizers
5 API Stability Enhancers
5 Topical
3 Rheology Modifiers
3 Emulsifying Agents
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Finished Drug Prices

3 US Medicaid Prescriptions
57 Finished Drug Prices

MARKET PLACE

5 APIs, 7 FDF Dossiers, 1 Intermediates

5 APIs
7 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 7 Others

2 EDQM
2 USP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 198 Xls

Filters

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filter Applicant Reset all filters

9 All

01 2Pharmacare Limited, Woodmead

02 2Acino Pharma (Pty) Ltd

03 2Mylan (Pty) Ltd

04 3Oethmaan Biosims (Pty) Ltd

filter Active Ingredients Reset all filters

9 All

01 9Clozapine

filter Dosage Form Reset all filters

9 All

01 9TAB

filter Brand Name Reset all filters

9 All

01 1Aspen Clozapine 100 Mg

02 1Aspen Clozapine 25 Mg

03 1Cloment 100

04 1Cloment 25

05 1Clozapine 100 Oethmaan

06 1Clozapine 25 Oethmaan

07 1Clozapine 50 Oethmaan

08 1Leponex 100mg

09 1Leponex 25mg

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Aspen Clozapine 25 Mg

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Pharmacare Limited, Woodmead

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Aspen Clozapine 100 Mg

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Clozapine 50 Oethmaan

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Clozapine 25 Oethmaan

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

Oethmaan Biosims (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Clozapine 100 Oethmaan

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Leponex 100mg

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Leponex 25mg

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Acino Pharma (Pty) Ltd

Country

2024 ACI Convention

Not Confirmed

Acino Pharma (Pty) Ltd

Country

2024 ACI Convention

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Country

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Cloment 25

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Acino Pharma (Pty) Ltd

Country

2024 ACI Convention

Not Confirmed

Acino Pharma (Pty) Ltd

Country

2024 ACI Convention

Not Confirmed

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Country

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Cloment 100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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