Ondansetron Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ondansetron Hydrochloride
South Africa

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Ondansetron Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 18 CEP/COS, 4 JDMF, 13 EU WC, 11 KDMF, 21 NDC API, 28 Listed Suppliers, $ API Reference Price

41 API Suppliers
20 USDMF
18 CEP/COS
4 JDMF
13 EU WC
11 KDMF
21 NDC API
28 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

169 FDF Dossiers, 102 FDA Orange Book, 36 Canada, 10 South Africa, 21 Listed Dossiers

169 FDF Dossiers
102 FDA Orange Book
36 Canada
10 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - EQ 4MG BASE/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 9 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 32 Disintegrants & Superdisintegrants, 31 Controlled & Modified Release, 29 Thickeners and Stabilizers, 27 Taste Masking, 24 Parenteral, 24 Granulation, 23 Lubricants & Glidants, 20 Film Formers & Plasticizers, 19 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 15 Solubilizers, 15 Topical, 9 Empty Capsules, 7 API Stability Enhancers, 7 Emulsifying Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

88 Fillers, Diluents & Binders
56 Coating Systems & Additives
41 Direct Compression
32 Disintegrants & Superdisintegrants
31 Controlled & Modified Release
29 Thickeners and Stabilizers
27 Taste Masking
24 Parenteral
24 Granulation
23 Lubricants & Glidants
20 Film Formers & Plasticizers
19 Co-Processed Excipients
19 Chewable & Orodispersible Aids
15 Solubilizers
15 Topical
9 Empty Capsules
7 API Stability Enhancers
7 Emulsifying Agents
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

5 NEWS #PharmaBuzz

5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Finished Drug Prices

2 US Medicaid Prescriptions
16 Finished Drug Prices

MARKET PLACE

16 APIs, 1 FDF Dossiers

16 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP, 1 Others

8 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 1,298 Xls

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10 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 6Ranbaxy Pharmaceuticals (Pty) Ltd

03 2Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 2Ondansetron (as hydrochloride)

02 8Ondansetron Hydrochloride

filter Dosage Form Reset all filters

10 All

01 4DSP

02 2FCT

03 4INJ

filter Brand Name Reset all filters

10 All

01 1Sabax Ondansetron injection 4mg/2ml

02 1Sabax Ondansetron injection 8mg/4ml

03 1Vomiz D 4mg

04 1Vomiz D 8mg

05 1Zofer 4 Mg Injection

06 1Zofer 4 Mg Tablets

07 1Zofer 8 Mg Injection

08 1Zofer 8 Mg Tablets

09 1Zofer Rapitab 4

10 1Zofer Rapitab 8

Athena Ondansetron Hydrochloride

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

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Adcock Ingram Critical Care (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron (as hydrochloride)

Brand Name : Sabax Ondansetron injection 4mg/2ml

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X2mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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02

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

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Adcock Ingram Critical Care (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron (as hydrochloride)

Brand Name : Sabax Ondansetron injection 8mg/4ml

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X4mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

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Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 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

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 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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05

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 4 Mg Tablets

Dosage Form : FCT

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

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 8 Mg Tablets

Dosage Form : FCT

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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Corporate PDF

07

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer Rapitab 4

Dosage Form : DSP

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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08

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer Rapitab 8

Dosage Form : DSP

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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09

Zydus Healthcare SA (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Zydus Healthcare SA (Pty) Ltd

Pharmtech & Ingredients

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Vomiz D 4mg

Dosage Form : DSP

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

Zydus Healthcare SA (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Zydus Healthcare SA (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Vomiz D 8mg

Dosage Form : DSP

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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