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Drug Approvals by the Medicines Control Council in South Africa containing MolPort-001-944-253. Original Data : South African Medicines Price Registry

Client Email

Product

MolPort-001-944-253
South Africa

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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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MolPort-001-944-253

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 8 USDMF, 8 EU WC, 3 KDMF, 7 NDC API, 20 Listed Suppliers, $ API Reference Price

24 API Suppliers
8 USDMF
8 EU WC
3 KDMF
7 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

35 Drugs in Development

35 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

INTERMEDIATES

8 API Suppliers

8 API Suppliers

FINISHED DOSAGE FORMULATIONS

426 FDF Dossiers, 29 FDA Orange Book, 143 Europe, 26 Canada, 88 Australia, 45 South Africa, 95 Listed Dossiers

426 FDF Dossiers
29 FDA Orange Book
143 Europe
26 Canada
88 Australia
45 South Africa
95 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;ORAL - 4MG, FILM;ORAL - 8MG

TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FILM;ORAL - 4MG
FILM;ORAL - 8MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 10 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Bioplus Life Sciences, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 50 Direct Compression, 47 Coating Systems & Additives, 45 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 27 Controlled & Modified Release, 26 Taste Masking, 25 Granulation, 24 Lubricants & Glidants, 23 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 19 Solubilizers, 18 Film Formers & Plasticizers, 16 Parenteral, 12 Topical, 9 Empty Capsules, 8 API Stability Enhancers, 7 Emulsifying Agents, 6 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

90 Fillers, Diluents & Binders
50 Direct Compression
47 Coating Systems & Additives
45 Disintegrants & Superdisintegrants
32 Thickeners and Stabilizers
27 Controlled & Modified Release
26 Taste Masking
25 Granulation
24 Lubricants & Glidants
23 Chewable & Orodispersible Aids
19 Co-Processed Excipients
19 Solubilizers
18 Film Formers & Plasticizers
16 Parenteral
12 Topical
9 Empty Capsules
8 API Stability Enhancers
7 Emulsifying Agents
6 Rheology Modifiers
4 Vegetarian Capsules
4 Coloring Agents
2 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 30 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
30 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

130 Finished Drug Prices

130 Finished Drug Prices

MARKET PLACE

14 APIs, 23 FDF Dossiers

14 APIs
23 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 2 Health Canada Patents

4 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 9 Others

4 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,228 Xls

Filters

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45 All

01 2Accord Healthcare (Pty) Ltd

02 4Austell Laboratories (Pty) Ltd

03 2Brimpharm Sa (Pty) Ltd

04 2Cipla Medpro (Pty) Ltd

05 4Mylan (Pty) Ltd

06 2Pharma Dynamics (Pty) Ltd

07 2Pharmacorp (Pty) Ltd

08 15Sandoz SA (Pty) Ltd

09 2Specpharm (Pty) Ltd

10 4Trinity Pharma (Pty) Ltd

11 6Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

45 All

01 43Ondansetron

02 2Ondasetron

filter Dosage Form Reset all filters

45 All

01 6DSP

02 2FCT

03 24INJ

04 2ODT

05 11TAB

filter Brand Name Reset all filters

45 All

01 1Alepet 4

02 1Alepet 8

03 1Aspetron 4 mg

04 1Aspetron 8 mg

05 2Austell Ondansetron 4mg Tablets

06 2Austell Ondansetron 8mg Tablets

07 1Danset 4 Mg

08 1Danset 8 Mg

09 3Dantron

10 1Dantron 4 Injection

11 1Dantron 8 Injection

12 1Emistop 4 mg

13 1Emistop 8 mg

14 1Mylan Ondansetron 4 mg/2 ml

15 1Mylan Ondansetron 8 mg/4 ml

16 1Nausetron 4,0 Mg Injection

17 1Nausetron 8,0 Mg Injection

18 1Omectron 4 ODT

19 1Omectron 8 ODT

20 1Ondansetron - Hexal 4mg Injection

21 1Ondansetron - Hexal 8mg Injection

22 1Ondansetron 4 ODT Unicorn

23 1Ondansetron 4 mg ODT Cipla

24 1Ondansetron 4mg/2 ml PharmC

25 1Ondansetron 8 ODT Unicorn

26 1Ondansetron 8 mg ODT Cipla

27 1Ondansetron 8 mg/4 ml PharmC

28 1Ondansetron Cipla IV 4 mg

29 1Vomiz 4 mg Tablets

30 1Vomiz 8 mg Injection

31 1Vomiz 8 mg Tablets

32 1Vomiz Injection 4mg/ 2ml

33 2Zofran 4mg Injection

34 1Zofran 4mg Tablets

35 2Zofran 8mg Injection

36 1Zofran 8mg Tablets

37 1Zofran zydis 4mg

38 1Zofran zydis 8mg

39 1Zydus-Ondansetron 8 mg Injection

Athena Ondansetron

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

AAPS 2024

Not Confirmed

Accord Healthcare (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Alepet 4

Dosage Form : INJ

Dosage Strength : 4 mg/2ml

Packaging : 2X5 mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Accord Healthcare (Pty) Ltd

AAPS 2024

Not Confirmed

Accord Healthcare (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Alepet 8

Dosage Form : INJ

Dosage Strength : 8 mg/4ml

Packaging : 4X5 mg/4ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Austell Ondansetron 8mg Tablets

Dosage Form : TAB

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Austell Ondansetron 4mg Tablets

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Austell Ondansetron 4mg Tablets

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

Austell Laboratories (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Austell Ondansetron 8mg Tablets

Dosage Form : TAB

Dosage Strength : 8mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Brimpharm Sa (Pty) Ltd

AAPS 2024

Not Confirmed

Brimpharm Sa (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Nausetron 4,0 Mg Injection

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 2X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Brimpharm Sa (Pty) Ltd

AAPS 2024

Not Confirmed

Brimpharm Sa (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Nausetron 8,0 Mg Injection

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 4X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Cipla Medpro (Pty) Ltd

AAPS 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Ondansetron 4 mg ODT Cipla

Dosage Form : ODT

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Cipla Medpro (Pty) Ltd

AAPS 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Ondansetron 8 mg ODT Cipla

Dosage Form : ODT

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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