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Drug Approvals by the Medicines Control Council in South Africa containing NCGC00024596-07. Original Data : South African Medicines Price Registry

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Product

NCGC00024596-07
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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NCGC00024596-07

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 20 USDMF, 17 CEP/COS, 8 JDMF, 1 EU WC, 7 KDMF, 14 NDC API, 18 Listed Suppliers, $ API Reference Price

39 API Suppliers
20 USDMF
17 CEP/COS
8 JDMF
1 EU WC
7 KDMF
14 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

FINISHED DOSAGE FORMULATIONS

343 FDF Dossiers, 118 FDA Orange Book, 167 Europe, 17 Canada, 12 South Africa, 29 Listed Dossiers

343 FDF Dossiers
118 FDA Orange Book
167 Europe
17 Canada
12 South Africa
29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET;ORAL - 25MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG, CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG, CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG, CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

TABLET;ORAL - 10MG;100MG
TABLET;ORAL - 25MG;100MG
TABLET;ORAL - 25MG;250MG
TABLET;ORAL - 25MG
TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG
CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG
CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG
CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG
TABLET;ORAL - 12.5MG;200MG;50MG
TABLET;ORAL - 18.75MG;200MG;75MG
TABLET;ORAL - 25MG;200MG;100MG
TABLET;ORAL - 31.25MG;200MG;125MG
TABLET;ORAL - 37.5MG;200MG;150MG
TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 3 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 47 Direct Compression, 46 Disintegrants & Superdisintegrants, 39 Controlled & Modified Release, 32 Thickeners and Stabilizers, 31 Solubilizers, 31 Granulation, 25 Taste Masking, 23 Lubricants & Glidants, 23 Film Formers & Plasticizers, 22 Parenteral, 21 Chewable & Orodispersible Aids, 20 Co-Processed Excipients, 13 Topical, 9 API Stability Enhancers, 8 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

92 Fillers, Diluents & Binders
65 Coating Systems & Additives
47 Direct Compression
46 Disintegrants & Superdisintegrants
39 Controlled & Modified Release
32 Thickeners and Stabilizers
31 Solubilizers
31 Granulation
25 Taste Masking
23 Lubricants & Glidants
23 Film Formers & Plasticizers
22 Parenteral
21 Chewable & Orodispersible Aids
20 Co-Processed Excipients
13 Topical
9 API Stability Enhancers
8 Emulsifying Agents
7 Rheology Modifiers
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 11 Annual Reports

9 US Medicaid Prescriptions
150 Finished Drug Prices
11 Annual Reports

MARKET PLACE

10 APIs, 9 FDF Dossiers

10 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

105 US Patents, 4 US Exclusivities

105 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 1 JP, 7 Others

3 EDQM
2 USP
1 JP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 360 Xls

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12 All

01 2Pharmacare Limited, Woodmead

02 3Equity Pharmaceuticals (Pty) Ltd

03 3Organon South Africa (Pty) Ltd

04 2Ranbaxy Pharmaceuticals (Pty) Ltd

05 2Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

12 All

01 12Carbidopa

filter Dosage Form Reset all filters

12 All

01 1SRT

02 11TAB

filter Brand Name Reset all filters

12 All

01 1Carbilev 25/100

02 1Carbilev 25/250

03 1Lecardop 25/100

04 1Lecardop 25/250

05 1Sinemet 25/100

06 1Sinemet 25/250

07 1Sinemet CR

08 1Stalevo 100/25

09 1Stalevo 150/37.5

10 1Stalevo 50/12.5

11 1Teva Carbi-Levo 25/100

12 1Teva Carbi-Levo 25/250

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Carbilev 25/100

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

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02

Pharmacare Limited, Woodmead

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Carbilev 25/250

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

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03

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Stalevo 50/12.5

Dosage Form : TAB

Dosage Strength : 12.5mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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04

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Stalevo 100/25

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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05

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Stalevo 150/37.5

Dosage Form : TAB

Dosage Strength : 37.5mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

Ranbaxy Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lecardop 25/100

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

07

Ranbaxy Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

AAPS 2024

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lecardop 25/250

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

08

Organon South Africa (Pty) Ltd

Country

AAPS 2024

Not Confirmed

Organon South Africa (Pty) Ltd

Country

AAPS 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sinemet 25/100

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

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Website

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09

Organon South Africa (Pty) Ltd

Country

AAPS 2024

Not Confirmed

Organon South Africa (Pty) Ltd

Country

AAPS 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sinemet 25/250

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Organon South Africa (Pty) Ltd

Country

AAPS 2024

Not Confirmed

Organon South Africa (Pty) Ltd

Country

AAPS 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sinemet CR

Dosage Form : SRT

Dosage Strength : 50mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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