Topotecan

ACCESS ALL DATA, CHEMISTRY

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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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

$ Xls

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USFDA APPLICATION NUMBER - 20671 / DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPOTECAN HYDROCHLORIDE(UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)	TOPOTECAN	4mg in 4

Inactive Ingredients

Ingredient Name	Accord Healthcare, Inc.	Cipla USA Inc.	GlaxoSmithKline LLC	GlaxoSmithKline Manufacturing SpA	Ingenus Pharmaceuticals, LLC	Mylan Institutional LLC	Pfizer Laboratories Div Pfizer Inc.	Sagent Pharmaceuticals	Sun Pharmaceutical Industries Limited	Three Rivers Pharmaceuticals, LLC.
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