Topotecan

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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

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates 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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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, 13 SPI Pharma, 6 DKSH, 1 Faran Shimi Pharmaceutical, 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, 8 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

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices

MARKET PLACE

3 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 4 Others

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USFDA APPLICATION NUMBER - 200582 / DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPOTECAN HYDROCHLORIDE(UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)	TOPOTECAN	1mg in 1

Inactive Ingredients

Ingredient Name	Hospira, Inc.	Mylan Institutional LLC	Mylan Laboratories Limited	Sagent Pharmaceuticals	Teva Parenteral Medicines, Inc.
hydrochloric acid(QTT17582CB)
MANNITOL(3OWL53L36A)
SODIUM HYDROXIDE(55X04QC32I)
TARTARIC ACID(W4888I119H)
WATER(059QF0KO0R)

Drug Product Composition: Topotecan

Topotecan

Topotecan

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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

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

3 Intermediates 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

13 SPI Pharma

6 DKSH

1 Faran Shimi Pharmaceutical

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

8 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

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

20 Finished Drug Prices

MARKET PLACE

3 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