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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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, 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, 10 Chewable & Orodispersible Aids, 10 Taste Masking, 9 Direct Compression, 8 Empty Capsules, 8 Co-Processed Excipients, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 5 Parenteral, 3 Solubilizers, 3 Granulation, 3 Disintegrants & Superdisintegrants, 2 Coloring Agents, 2 Film Formers & Plasticizers, 1 Topical, 1 API Stability Enhancers

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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01 24SPI Pharma

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01

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Brand Name : TAP®

Application : Solubilizers

Excipient Details : TAP® pellets are spherical cores made of tartaric acid used for solubility enhancement of drugs exhibiting poor solubility in alkali environments.

Pharmacopoeia Ref : NA

Technical Specs : Bulk density: 0.8-1.1

Ingredient(s) : Tartaric Acid

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Tartaric Acid

Dosage Form : Capsule, Granule / Pellet, Tablet

Category : Solubilizers

Brand : TAP®

Applications : TAP® pellets are spherical cores made of tartaric acid used for solubility enhancement of drugs exhibiting poor solubility in alkali environments.

Pharmacopoeia Ref : NA

Technical Specs : Bulk density: 0.8-1.1

Grade : Oral

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Advantol 300

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chewable or soft melt oral dosage forms & enables rapid product development.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand : ADVANTOL 300

Applications : Advantol® 300 is a DC pharmaceutical excipient used to create soft chewable or soft melt oral dosage forms & enables rapid product development.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

03

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Brand Name : Compressol SM

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol, Sorbitol

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol, Sorbitol

Dosage Form : Tablet, Orodispersible Tablet

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand : COMPRESSOL SM

Applications : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

04

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Mannogem EZ Spray-Dried

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Excipient Details : Mannogem EZ Spray-Dried, a mannitol product, dissolves rapidly and can increase the rate of tablet disintegration, drug dissolution & drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Brand : MANNOGEM EZ SPRAY-DRIED

Applications : Mannogem EZ Spray-Dried, a mannitol product, dissolves rapidly and can increase the rate of tablet disintegration, drug dissolution & drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

05

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Mannogem Granular

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Excipient Details : Mannogem Granular (mannitol) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Brand : MANNOGEM GRANULAR

Applications : Mannogem Granular (mannitol) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

06

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

Brand Name : Mannogem Powder

Application : Fillers, Diluents & Binders, Granulation

Excipient Details : Mannogem (mannitol powder) is a pharmaceutical excipient that dissolves rapidly and increases tablet disintegration rate, drug dissolution & release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Granule / Pellet, Tablet

Category : Fillers, Diluents & Binders, Granulation

Brand : MANNOGEM POWDER

Applications : Mannogem (mannitol powder) is a pharmaceutical excipient that dissolves rapidly and increases tablet disintegration rate, drug dissolution & release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

07

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Brand Name : Mannogem XL Mannitol

Application : API Stability Enhancers, Chewable & Orodispersible Aids, Fillers, Diluents & Binders

Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Tablet, Orodispersible Tablet

Category : API Stability Enhancers, Chewable & Orodispersible Aids, Fillers, Diluents & Binders

Brand : MANNOGEM XL MANNITOL

Applications : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

08

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Brand Name : Mannogem® Emerald

Application : Taste Masking

Excipient Details : Mannogem Emerald is a compendial, powder mannitol dissolves quickly, delivering excellent palatability through a creamy texture and mild sweetness.

Pharmacopoeia Ref : NA

Technical Specs : 25 µm Powder Mannitol

Ingredient(s) : Mannitol

Dosage Form : Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Tablet

Category : Taste Masking

Brand : MANNOGEM® EMERALD

Applications : Mannogem Emerald is a compendial, powder mannitol dissolves quickly, delivering excellent palatability through a creamy texture and mild sweetness.

Pharmacopoeia Ref : NA

Technical Specs : 25 µm Powder Mannitol

Grade : Oral

09

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Brand Name : Mannogem® Onyx

Application : Fillers, Diluents & Binders

Excipient Details : Mannogem® Onyx is a compendial, powder mannitol has reduced sensitivity to lubricants, low friability, and high binding capacity.

Pharmacopoeia Ref : NA

Technical Specs : 50 µm Powder Mannitol

Ingredient(s) : Mannitol

Dosage Form : Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Tablet

Category : Fillers, Diluents & Binders

Brand : MANNOGEM® ONYX

Applications : Mannogem® Onyx is a compendial, powder mannitol has reduced sensitivity to lubricants, low friability, and high binding capacity.

Pharmacopoeia Ref : NA

Technical Specs : 50 µm Powder Mannitol

Grade : Oral

10

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

Dosage Form : Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Tablet

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand : MANNOGEM® XL OPAL

Applications : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Grade : Oral

11

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Mannogem® XL Ruby

Application : Chewable & Orodispersible Aids, Taste Masking

Excipient Details : Mannogem XL Ruby, granular mannitol used in pressure-sensitive, taste-masked APIs provides excellent tabletability in chewable tablets & soft-chews.

Pharmacopoeia Ref : NA

Technical Specs : 300 µm Granular Mannitol

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Taste Masking

Brand : MANNOGEM® XL RUBY

Applications : Mannogem XL Ruby, granular mannitol used in pressure-sensitive, taste-masked APIs provides excellent tabletability in chewable tablets & soft-chews.

Pharmacopoeia Ref : NA

Technical Specs : 300 µm Granular Mannitol

Grade : Oral

12

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand : PHARMABURST 500

Applications : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

13

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Pharmasperse 416

Application : Chewable & Orodispersible Aids, Taste Masking

Excipient Details : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

SPI Pharma has been solving formulation challenges using superior functional materials.

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Taste Masking

Brand : PHARMASPERSE 416

Applications : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

Looking for Pharmaceutical Excipients offered by SPI Pharma? Find Topotecan to address your drug delivery challenges on PharmaCompass.

Topotecan

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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

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

10 Chewable & Orodispersible Aids

10 Taste Masking

9 Direct Compression

8 Empty Capsules

8 Co-Processed Excipients

6 Coating Systems & Additives

5 Thickeners and Stabilizers

5 Parenteral

3 Solubilizers

3 Granulation

3 Disintegrants & Superdisintegrants

2 Coloring Agents

2 Film Formers & Plasticizers

1 Topical

1 API Stability Enhancers

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