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Drug Approvals by the Medicines Control Council in South Africa containing CID2818. Original Data : South African Medicines Price Registry

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Product

CID2818
South Africa

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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CID2818

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 9 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

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TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or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 Thickeners and Stabilizers, 21 Co-Processed Excipients, 20 Chewable & Orodispersible Aids, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 14 Controlled & Modified Release, 12 Parenteral, 8 Solubilizers, 5 Topical, 5 API Stability Enhancers, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

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

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

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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

FDF Dossiers
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Listed Dossiers

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01

Pharmacare Limited, Woodmead

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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

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Product Web Link

Digital Content

Corporate PDF

02

Pharmacare Limited, Woodmead

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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

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03

Oethmaan Biosims (Pty) Ltd

Fall Technical Meeting

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Oethmaan Biosims (Pty) Ltd

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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

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04

Oethmaan Biosims (Pty) Ltd

Fall Technical Meeting

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Oethmaan Biosims (Pty) Ltd

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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

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05

Oethmaan Biosims (Pty) Ltd

Fall Technical Meeting

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Oethmaan Biosims (Pty) Ltd

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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

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06

Mylan (Pty) Ltd

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Mylan (Pty) Ltd

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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

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07

Mylan (Pty) Ltd

Fall Technical Meeting

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Mylan (Pty) Ltd

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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

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08

Acino Pharma (Pty) Ltd

Country

Fall Technical Meeting

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Acino Pharma (Pty) Ltd

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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

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Product Web Link

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09

Acino Pharma (Pty) Ltd

Country

Fall Technical Meeting

Not Confirmed

Acino Pharma (Pty) Ltd

Country

Fall Technical Meeting

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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

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