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

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Ondansetron Hydrochloride
South Africa

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Ondansetron Hydrochloride

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 7 EU WC, 14 KDMF, 22 NDC API, 30 Listed Suppliers, $ API Reference Price

64 API Suppliers
20 USDMF
18 CEP/COS
6 JDMF
7 EU WC
14 KDMF
22 NDC API
30 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers, 102 FDA Orange Book, 39 Canada, 8 South Africa, 21 Listed Dossiers

170 FDF Dossiers
102 FDA Orange Book
39 Canada
8 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INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 5 Rochem International Inc, 19 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 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, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 32 Disintegrants & Superdisintegrants, 31 Direct Compression, 30 Controlled & Modified Release, 28 Taste Masking, 28 Thickeners and Stabilizers, 24 Granulation, 23 Parenteral, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 19 Film Formers & Plasticizers, 19 Chewable & Orodispersible Aids, 17 Topical, 16 Solubilizers, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

84 Fillers, Diluents & Binders
53 Coating Systems & Additives
32 Disintegrants & Superdisintegrants
31 Direct Compression
30 Controlled & Modified Release
28 Taste Masking
28 Thickeners and Stabilizers
24 Granulation
23 Parenteral
22 Lubricants & Glidants
21 Co-Processed Excipients
19 Film Formers & Plasticizers
19 Chewable & Orodispersible Aids
17 Topical
16 Solubilizers
9 Empty Capsules
7 Emulsifying Agents
7 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

5 News #PharmaBuzz

5 News #PharmaBuzz

GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 16 Regulatory FDF Prices

40 US Medicaid Prescriptions
16 Regulatory FDF Prices

MARKET PLACE

18 APIs, 2 FDF Dossiers

18 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP

8 EDQM
1 USP

$ API Ref.Price (USD/KG) : 1,209 Xls

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8 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 6Ranbaxy Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 2Ondansetron (as hydrochloride)

02 6Ondansetron Hydrochloride

filter Dosage Form Reset all filters

8 All

01 2DSP

02 2FCT

03 4INJ

filter Brand Name Reset all filters

8 All

01 1Sabax Ondansetron injection 4mg/2ml

02 1Sabax Ondansetron injection 8mg/4ml

03 1Zofer 4 Mg Injection

04 1Zofer 4 Mg Tablets

05 1Zofer 8 Mg Injection

06 1Zofer 8 Mg Tablets

07 1Zofer Rapitab 4

08 1Zofer Rapitab 8

List of Suppliers

Product Main Page

01

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 (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

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmex

Not Confirmed

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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

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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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

Portfolio PDF

Product Web Link

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Corporate PDF

04

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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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

Digital Content

Corporate PDF

05

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

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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

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06

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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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

Digital Content

Corporate PDF

07

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

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

Product Web Link

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Corporate PDF

08

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Pharmex

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

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Product Web Link

Digital Content

Corporate PDF

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