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Topotecan Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 6 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 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

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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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

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

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 Coloring Agents, 2 Film Formers & Plasticizers, 1 Topical

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Regulatory FDF Prices

MARKET PLACE

4 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 4 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Cipla	India	CIPLA LTD	21621	TOPOTECAN HYDROCHLORIDE	2008-07-17	Inactive	II	N/A
28/03/2025	Emcure Pharmaceuticals	India	EMCURE PHARMACEUTICALS LTD	23443	TOPOTECAN HYDROCHLORIDE	2010-01-11	Active	II	N/A

Topotecan Hydrochloride

Topotecan Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers

6 USDMF

1 EU WC

4 KDMF

3 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

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

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

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

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 Coloring Agents

2 Film Formers & Plasticizers

1 Topical

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

21 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

20 Regulatory FDF Prices

MARKET PLACE

4 APIs

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