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Drug Approvals by the Medicines Control Council in South Africa containing Topotecan. Original Data : South African Medicines Price Registry

Client Email

Product

Topotecan
Camptothecine
South Africa

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Topotecan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 8 USDMF, 1 EU WC, 4 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

18 API Suppliers
8 USDMF
1 EU WC
4 KDMF
3 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

3 API Suppliers

3 API 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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 13 SPI Pharma, 6 DKSH, 1 Pfanstiehl, 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
13 SPI Pharma
6 DKSH
1 Pfanstiehl
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, 10 Chewable & Orodispersible Aids, 10 Taste Masking, 9 Direct Compression, 8 Empty Capsules, 7 Co-Processed Excipients, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 5 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Granulation, 2 Coloring Agents, 2 Film Formers & Plasticizers, 2 Solubilizers, 1 API Stability Enhancers, 1 Topical

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

2 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

3 APIs, 5 FDF Dossiers

3 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) : 760,431 Xls

Filters

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filter Applicant Reset all filters

4 All

01 1Medivision (Pty) Ltd

02 3Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

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

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Medivision (Pty) Ltd

AAPS 2024

Not Confirmed

Medivision (Pty) Ltd

AAPS 2024

Not Confirmed

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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 : 4X1mg/4 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

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

Product Web Link

Digital Content

03

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

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

Product Web Link

Digital Content

04

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

Sandoz SA (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Topotecan Hydrochloride

Brand Name : Hycamtin 0.25mg

Dosage Form : CAP

Dosage Strength : 0.25mg mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Product Web Link

Digital Content

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