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

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Topotecan Hydrochloride
South Africa

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Topotecan Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 8 USDMF, 1 EU WC, 4 KDMF, 3 NDC API, 11 Listed Suppliers, $ API Reference Price

17 API Suppliers
8 USDMF
1 EU WC
4 KDMF
3 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

72 FDF Dossiers, 22 FDA Orange Book, 31 Europe, 5 Canada, 4 Australia, 4 South Africa, 6 Listed Dossiers

72 FDF Dossiers
22 FDA Orange Book
31 Europe
5 Canada
4 Australia
4 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ 0.25MG BASE, CAPSULE;ORAL - EQ 1MG BASE

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
INJECTABLE;INJECTION - EQ 4MG BASE/VIAL
CAPSULE;ORAL - EQ 0.25MG BASE
CAPSULE;ORAL - EQ 1MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 6 DKSH, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 1 Actylis, 2 BASF, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 2 Microlex e.U, 1 Pluviaendo, 1 Qualicaps, 5 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

1 Rochem International Inc
14 SPI Pharma
6 DKSH
1 Faran Shimi Pharmaceutical
1 Gangwal Healthcare
1 Pfanstiehl
1 Capital Farma
4 ACG Worldwide
1 Actylis
2 BASF
3 Gangwal Chemicals
1 Ingredion Pharma Solutions
6 Kerry
3 Lonza Capsugel
2 Microlex e.U
1 Pluviaendo
1 Qualicaps
5 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 11 Chewable & Orodispersible Aids, 11 Taste Masking, 10 Direct Compression, 9 Co-Processed Excipients, 8 Empty Capsules, 7 Disintegrants & Superdisintegrants, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 5 Parenteral, 4 Solubilizers, 3 Granulation, 2 Film Formers & Plasticizers, 2 Coloring Agents, 1 Topical

21 Fillers, Diluents & Binders
11 Chewable & Orodispersible Aids
11 Taste Masking
10 Direct Compression
9 Co-Processed Excipients
8 Empty Capsules
7 Disintegrants & Superdisintegrants
6 Coating Systems & Additives
5 Thickeners and Stabilizers
5 Parenteral
4 Solubilizers
3 Granulation
2 Film Formers & Plasticizers
2 Coloring Agents
1 Topical

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices

1 US Medicaid Prescriptions
20 Finished Drug Prices

MARKET PLACE

4 APIs, 5 FDF Dossiers

4 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

2 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 4 Others

2 USP
4 Others

$ API Ref.Price (USD/KG) : 757,305 Xls

Filters

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01 1Glaxosmithkline South Africa (Pty) Ltd - Cape Town

02 1Medivision (Pty) Ltd

03 2Novartis South Africa (Pty) Ltd

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4 All

01 1Topotecan HCl

02 3Topotecan Hydrochloride

filter Dosage Form Reset all filters

4 All

01 2CAP

02 2INJ

filter Brand Name Reset all filters

4 All

01 1Hycamtin 0.25mg

02 1Hycamtin 1mg

03 1Hycamtin 5Ml

04 1Meditop 4 mg

Topotecan Hydrochloride

List of Suppliers

Product Main Page

01

Glaxosmithkline South Africa (Pty) Ltd -...

The Generic Rx Session

Not Confirmed

Glaxosmithkline South Africa (Pty) Ltd -...

The Generic Rx Session

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Regulatory Info : Originator

Registration Country : South Africa

Topotecan Hydrochloride

Brand Name : Hycamtin 5Ml

Dosage Form : INJ

Dosage Strength : 4mg/4ml

Packaging : 4X2mg/4ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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02

Medivision (Pty) Ltd

The Generic Rx Session

Not Confirmed

Medivision (Pty) Ltd

The Generic Rx Session

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Regulatory Info : Generic

Registration Country : South Africa

Topotecan HCl

Brand Name : Meditop 4 mg

Dosage Form : INJ

Dosage Strength : 4mg/4 ml

Packaging : 4 mlX1mg/4 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Novartis South Africa (Pty) Ltd

Country

The Generic Rx Session

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

The Generic Rx Session

Not Confirmed

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Country

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Regulatory Info : Originator

Registration Country : South Africa

Topotecan Hydrochloride

Brand Name : Hycamtin 1mg

Dosage Form : CAP

Dosage Strength : 1mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Virtual Booth

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04

Novartis South Africa (Pty) Ltd

Country

The Generic Rx Session

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

The Generic Rx Session

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Topotecan Hydrochloride

Brand Name : Hycamtin 0.25mg

Dosage Form : CAP

Dosage Strength : 122mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Virtual Booth

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Website

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