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

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Topotecan Hydrochloride
South Africa

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Topotecan Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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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

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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Taste Masking, 10 Chewable & Orodispersible Aids, 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 Film Formers & Plasticizers, 2 Solubilizers, 2 Coloring Agents, 1 API Stability Enhancers, 1 Topical

21 Fillers, Diluents & Binders
10 Taste Masking
10 Chewable & Orodispersible Aids
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 Film Formers & Plasticizers
2 Solubilizers
2 Coloring Agents
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

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01 1Medivision (Pty) Ltd

02 3Sandoz SA (Pty) Ltd

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01 1Topotecan HCl

02 3Topotecan Hydrochloride

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01 2CAP

02 2INJ

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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

Medivision (Pty) Ltd

2024 ACI Convention

Not Confirmed

Medivision (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

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

2024 ACI Convention

Not Confirmed

Sandoz SA (Pty) Ltd

2024 ACI Convention

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

2024 ACI Convention

Not Confirmed

Sandoz SA (Pty) Ltd

2024 ACI Convention

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

2024 ACI Convention

Not Confirmed

Sandoz SA (Pty) Ltd

2024 ACI Convention

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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