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Drug Approvals by the Medicines Control Council in South Africa containing Tox21_202441. Original Data : South African Medicines Price Registry

Client Email

Product

Tox21_202441
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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Tox21_202441

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 1 USDMF, 3 CEP/COS, 3 JDMF, 6 Listed Suppliers, $ API Reference Price

10 API Suppliers
1 USDMF
3 CEP/COS
3 JDMF
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

124 FDF Dossiers, 18 FDA Orange Book, 19 Europe, 6 Canada, 27 South Africa, 54 Listed Dossiers

124 FDF Dossiers
18 FDA Orange Book
19 Europe
6 Canada
27 South Africa
54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL, INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL, INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

RELATED EXCIPIENT COMPANIES

12 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 15 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 1 Bioplus Life Sciences, 11 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 21 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 11 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 45 Thickeners and Stabilizers, 39 Direct Compression, 38 Solubilizers, 36 Taste Masking, 35 Controlled & Modified Release, 30 Parenteral, 26 Granulation, 26 Topical, 24 Film Formers & Plasticizers, 23 Disintegrants & Superdisintegrants, 20 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 12 Emulsifying Agents, 12 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

87 Fillers, Diluents & Binders
60 Coating Systems & Additives
45 Thickeners and Stabilizers
39 Direct Compression
38 Solubilizers
36 Taste Masking
35 Controlled & Modified Release
30 Parenteral
26 Granulation
26 Topical
24 Film Formers & Plasticizers
23 Disintegrants & Superdisintegrants
20 Co-Processed Excipients
19 Chewable & Orodispersible Aids
19 Lubricants & Glidants
12 Emulsifying Agents
12 Rheology Modifiers
10 API Stability Enhancers
9 Empty Capsules
5 Surfactant & Foaming Agents
4 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 9 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

13 Finished Drug Prices

13 Finished Drug Prices

MARKET PLACE

15 APIs, 1 FDF Dossiers

15 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 2 Others

1 EDQM
1 USP
2 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 55 Xls

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01 1Pharmacare Limited, Woodmead

02 1Fresenius Kabi SA (Pty) Ltd

03 20Fresenius Kabi South Africa (Pty) Ltd

04 2Ingelheim Pharmaceuticals (Pty) Ltd

05 3Pharmaceutical Enterprises (Pty) Ltd

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27 All

01 27Vitamin A

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27 All

01 4CAP

02 1INF

03 4INJ

04 2TAB

05 16TPN

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01 1Complenatal FF

02 1Filibon

03 2Gericomplex

04 1ITN5501XA

05 1ITN66A

06 1ITN8801A

07 2ITN8801XA

08 1ITN8807XA

09 1ITN8811A

10 1ITNBABY 100

11 1ITNBABY 101

12 1ITNBABY 102

13 1ITNBABY 103

14 1ITNBABY 104

15 1ITNBABY105

16 2ITNPAED106

17 1ITNPAED108

18 1Intramed Dextrose 20%/500ml

19 2Menoflush

20 2Vitalipid Novum Adult

21 2Vitalipid Novum Infant

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 : Filibon

Dosage Form : CAP

Dosage Strength : 4000u

Packaging : 30X1u

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

Fresenius Kabi SA (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi SA (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Intramed Dextrose 20%/500ml

Dosage Form : INF

Dosage Strength : 3300IU

Packaging : 500X18g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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03

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNBABY 101

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 150X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNBABY 102

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 150X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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05

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNBABY 103

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 235X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNPAED106

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 750X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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07

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNPAED106

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 750X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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08

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNPAED108

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 1400X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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09

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITN66A

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 510X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : ITNBABY 100

Dosage Form : TPN

Dosage Strength : 3mg

Packaging : 150X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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