Topotecan Hydrochloride

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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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

Filters

Xls

USFDA APPLICATION NUMBER - 20981 / DOSAGE - CAPSULE;ORAL - EQ 0.25MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPOTECAN HYDROCHLORIDE(UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)	TOPOTECAN	1mg \| 0.25mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline LLC	GlaxoSmithKline Manufacturing SpA
FERRIC OXIDE RED(1K09F3G675)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERYL MONOSTEARATE(230OU9XXE4)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Topotecan Hydrochloride