ondansetron (Zofran) | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ondansetron (Zofran)
South Africa

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ondansetron (Zofran)

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 8 USDMF, 9 EU WC, 3 KDMF, 10 NDC API, 22 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

87 Drugs in Development

87 Drugs in Development

INTERMEDIATES

11 Intermediate Suppliers

11 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

539 FDF Dossiers, 29 FDA Orange Book, 242 Europe, 24 Canada, 88 Australia, 51 South Africa, 105 Listed Dossiers

539 FDF Dossiers
29 FDA Orange Book
242 Europe
24 Canada
88 Australia
51 South Africa
105 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TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;ORAL - 4MG, FILM;ORAL - 8MG

TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 4 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Shanghai Minbiotech, 1 Pfanstiehl, 5 Kirsch Pharma, 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, 2 CD Formulation, 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, 24 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

71 Fillers, Diluents & Binders, 46 Disintegrants & Superdisintegrants, 45 Direct Compression, 42 Coating Systems & Additives, 33 Thickeners and Stabilizers, 30 Granulation, 28 Taste Masking, 25 Chewable & Orodispersible Aids, 23 Lubricants & Glidants, 22 Controlled & Modified Release, 20 Solubilizers, 19 Parenteral, 17 Film Formers & Plasticizers, 13 Co-Processed Excipients, 13 Topical, 9 Empty Capsules, 9 Rheology Modifiers, 7 API Stability Enhancers, 7 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

71 Fillers, Diluents & Binders
46 Disintegrants & Superdisintegrants
45 Direct Compression
42 Coating Systems & Additives
33 Thickeners and Stabilizers
30 Granulation
28 Taste Masking
25 Chewable & Orodispersible Aids
23 Lubricants & Glidants
22 Controlled & Modified Release
20 Solubilizers
19 Parenteral
17 Film Formers & Plasticizers
13 Co-Processed Excipients
13 Topical
9 Empty Capsules
9 Rheology Modifiers
7 API Stability Enhancers
7 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring Agents
3 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

32 News #PharmaBuzz

32 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 69 Regulatory FDF Prices

8 US Medicaid Prescriptions
69 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

12 Others

12 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,386 Xls

Filters

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51 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 2Fresenius Kabi South Africa (Pty) Ltd

08 2Mylan (Pty) Ltd

09 2Pharma Dynamics (Pty) Ltd

10 2Pharmacorp (Pty) Ltd

11 15Sandoz SA (Pty) Ltd

12 2Specpharm (Pty) Ltd

13 4Trinity Pharma (Pty) Ltd

14 2Viatris South Africa (Pty) Ltd

15 4Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

51 All

01 49Ondansetron

02 2Ondansetron hydrochloride dihydrate

filter Dosage Form Reset all filters

51 All

01 6DSP

02 2FCT

03 28INJ

04 4ODT

05 11TAB

filter Brand Name Reset all filters

51 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 1Ondansetron Cipla IV 4 mg

33 1Ondansetron Fresenius 2mg/ml (4mg/2ml)

34 1Ondansetron Fresenius 2mg/ml (8mg/4ml)

35 1Vomiz 8 mg Injection

36 1Vomiz Injection 4mg/ 2ml

37 2Zofran 4mg Injection

38 1Zofran 4mg Tablets

39 2Zofran 8mg Injection

40 1Zofran 8mg Tablets

41 1Zofran zydis 4mg

42 1Zofran zydis 8mg

43 1Zofremet 4 ODT

44 1Zofremet 8 ODT

45 1Zydus-Ondansetron 8 mg Injection

Athena Ondansetron

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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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

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02

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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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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03

Adcock Ingram Critical Care (Pty) Ltd

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Adcock Ingram Critical Care (Pty) Ltd

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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

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Adcock Ingram Critical Care (Pty) Ltd

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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

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Corporate PDF

05

Austell Pharmaceuticals (Pty) Ltd

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Austell Pharmaceuticals (Pty) Ltd

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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

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06

Austell Pharmaceuticals (Pty) Ltd

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Austell Pharmaceuticals (Pty) Ltd

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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

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07

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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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

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08

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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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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09

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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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 : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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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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