DSSTox_CID_3393 | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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DSSTox_CID_3393
South Africa

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DSSTox_CID_3393

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 8 USDMF, 10 EU WC, 3 KDMF, 10 NDC API, 22 Listed Suppliers, $ API Reference Price

32 API Suppliers
8 USDMF
10 EU WC
3 KDMF
10 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

443 FDF Dossiers, 29 FDA Orange Book, 143 Europe, 24 Canada, 94 Australia, 45 South Africa, 108 Listed Dossiers

443 FDF Dossiers
29 FDA Orange Book
143 Europe
24 Canada
94 Australia
45 South Africa
108 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TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;ORAL - 4MG, FILM;ORAL - 8MG

TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 23 SPI Pharma, 12 DKSH, 2 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Shanghai Minbiotech, 1 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 Bioplus Life Sciences, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 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, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 46 Disintegrants & Superdisintegrants, 45 Coating Systems & Additives, 39 Direct Compression, 31 Thickeners and Stabilizers, 27 Taste Masking, 26 Controlled & Modified Release, 25 Granulation, 23 Chewable & Orodispersible Aids, 23 Lubricants & Glidants, 21 Co-Processed Excipients, 20 Solubilizers, 17 Film Formers & Plasticizers, 14 Parenteral, 13 Topical, 9 Empty Capsules, 8 Rheology Modifiers, 7 API Stability Enhancers, 7 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

31 News #PharmaBuzz

31 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 130 Regulatory FDF Prices

8 US Medicaid Prescriptions
130 Regulatory FDF 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 Others

4 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,415 Xls

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45 All

01 2Accord Healthcare (Pty) Ltd

02 2Adcock Ingram Critical Care (Pty) Ltd

03 4Austell Laboratories (Pty) Ltd

04 2Austell Pharmaceuticals (Pty) Ltd

05 4Biotech Laboratories (Pty) Ltd

06 2Cipla Medpro (Pty) Ltd

07 2Mylan (Pty) Ltd

08 2Pharma Dynamics (Pty) Ltd

09 2Pharmacorp (Pty) Ltd

10 15Sandoz SA (Pty) Ltd

11 2Specpharm (Pty) Ltd

12 4Trinity Pharma (Pty) Ltd

13 2Viatris South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

45 All

01 45Ondansetron

filter Dosage Form Reset all filters

45 All

01 6DSP

02 2FCT

03 22INJ

04 4ODT

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 Mg Injection

17 1Nausetron 8 Mg Injection

18 1ONDANSETRON 4 BIOTECH

19 1ONDANSETRON 4 mg/2 mL BIOTECH

20 1ONDANSETRON 8 BIOTECH

21 1ONDANSETRON 8 mg/4 mL BIOTECH

22 1Omectron 4 ODT

23 1Omectron 8 ODT

24 1Ondansetron - Hexal 4mg Injection

25 1Ondansetron - Hexal 8mg Injection

26 1Ondansetron 4 ODT Unicorn

27 1Ondansetron 4 mg ODT Cipla

28 1Ondansetron 4mg/2 ml PharmC

29 1Ondansetron 8 ODT Unicorn

30 1Ondansetron 8 mg ODT Cipla

31 1Ondansetron 8 mg/4 ml PharmC

32 2Zofran 4mg Injection

33 1Zofran 4mg Tablets

34 2Zofran 8mg Injection

35 1Zofran 8mg Tablets

36 1Zofran zydis 4mg

37 1Zofran zydis 8mg

38 1Zofremet 4 ODT

39 1Zofremet 8 ODT

Athena Ondansetron

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

Pharmex

Not Confirmed

Accord Healthcare (Pty) Ltd

Pharmex

Not Confirmed

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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

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Product Web Link

Digital Content

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02

Accord Healthcare (Pty) Ltd

Pharmex

Not Confirmed

Accord Healthcare (Pty) Ltd

Pharmex

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

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Corporate PDF

03

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Nausetron 4 Mg Injection

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 2X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Nausetron 8 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

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Corporate PDF

05

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Zofremet 4 ODT

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

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06

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron

Brand Name : Zofremet 8 ODT

Dosage Form : ODT

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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07

Austell Laboratories (Pty) Ltd

Pharmex

Not Confirmed

Austell Laboratories (Pty) Ltd

Pharmex

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

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08

Austell Laboratories (Pty) Ltd

Pharmex

Not Confirmed

Austell Laboratories (Pty) Ltd

Pharmex

Not Confirmed

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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

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Product Web Link

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09

Austell Laboratories (Pty) Ltd

Pharmex

Not Confirmed

Austell Laboratories (Pty) Ltd

Pharmex

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

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10

Austell Laboratories (Pty) Ltd

Pharmex

Not Confirmed

Austell Laboratories (Pty) Ltd

Pharmex

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

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