Topotecan Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 6 USDMF, 1 JDMF, 4 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

45 Drugs in Development

45 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

89 FDF Dossiers, 22 FDA Orange Book, 48 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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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 Gangwal Healthcare, 1 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 1 Actylis, 2 BASF, 1 CD Formulation, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 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, 12 Chewable & Orodispersible Aids, 11 Taste Masking, 10 Direct Compression, 8 Empty Capsules, 7 Disintegrants & Superdisintegrants, 6 Coating Systems & Additives, 6 Thickeners and Stabilizers, 5 Parenteral, 5 Solubilizers, 3 Co-Processed Excipients, 3 Granulation, 2 Coloring Agents, 2 Film Formers & Plasticizers, 2 Topical, 1 Controlled & Modified Release

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 12 Regulatory FDF Prices

MARKET PLACE

5 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ Xls

Filters

Xls

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)

Setid 3c15da96 D309 4b93 F5aa Cfb52c25c174 Applno 20671 Form Injectable Injection Dosage Eq 4mg Base Vial - Drug Product Composition: Topotecan Hydrochloride