8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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

Axplora- The partner of choice for complex APIs.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 10 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 9 NDC API, 15 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

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

203 FDF Dossiers
60 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TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or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

2 EUROAPI, 1 Minakem, 5 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 3 Actylis, 1 Aeon Procare, 6 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, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders, 30 Direct Compression, 29 Taste Masking, 24 Disintegrants & Superdisintegrants, 22 Granulation, 21 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 20 Thickeners and Stabilizers, 20 Coating Systems & Additives, 19 Film Formers & Plasticizers, 18 Co-Processed Excipients, 13 Controlled & Modified Release, 13 Parenteral, 8 Solubilizers, 6 Topical, 4 API Stability Enhancers, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

84 Fillers, Diluents & Binders
30 Direct Compression
29 Taste Masking
24 Disintegrants & Superdisintegrants
22 Granulation
21 Lubricants & Glidants
20 Chewable & Orodispersible Aids
20 Thickeners and Stabilizers
20 Coating Systems & Additives
19 Film Formers & Plasticizers
18 Co-Processed Excipients
13 Controlled & Modified Release
13 Parenteral
8 Solubilizers
6 Topical
4 API Stability Enhancers
3 Rheology Modifiers
3 Emulsifying Agents
1 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

29 News #PharmaBuzz

29 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Regulatory FDF Prices

3 US Medicaid Prescriptions
57 Regulatory FDF 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) : 215 Xls

Filters

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filter Applicant Reset all filters

9 All

01 2Pharmacare Limited, Woodmead

02 2Litha 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

Bio-Europe Spring

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

DCAT Week

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

Litha Pharma (Pty) Ltd

DCAT Week

Not Confirmed

Litha Pharma (Pty) Ltd

DCAT Week

Not Confirmed

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Digital Content

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

Digital Content

Corporate PDF

04

Litha Pharma (Pty) Ltd

DCAT Week

Not Confirmed

Litha Pharma (Pty) Ltd

DCAT Week

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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

Digital Content

Corporate PDF

05

Oethmaan Biosims (Pty) Ltd

Battery Seminar

Not Confirmed

Oethmaan Biosims (Pty) Ltd

Battery Seminar

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

06

Oethmaan Biosims (Pty) Ltd

Battery Seminar

Not Confirmed

Oethmaan Biosims (Pty) Ltd

Battery Seminar

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

07

Oethmaan Biosims (Pty) Ltd

Battery Seminar

Not Confirmed

Oethmaan Biosims (Pty) Ltd

Battery Seminar

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

08

Mylan (Pty) Ltd

DCAT Week

Not Confirmed

Mylan (Pty) Ltd

DCAT Week

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

09

Mylan (Pty) Ltd

DCAT Week

Not Confirmed

Mylan (Pty) Ltd

DCAT Week

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

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