Gemcitabine

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

100 API Suppliers, 29 USDMF, 26 CEP/COS, 13 JDMF, 9 EU WC, 30 KDMF, 18 NDC API, 46 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

847 Drugs in Development

847 Drugs in Development

INTERMEDIATES

19 Intermediate Suppliers

19 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

253 FDF Dossiers, 92 FDA Orange Book, 91 Europe, 4 Canada, 4 Australia, 22 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Gangwal Healthcare, 1 Pfanstiehl, 1 Kirsch Pharma, 1 Actylis, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 12 Chewable & Orodispersible Aids, 10 Taste Masking, 10 Direct Compression, 7 Disintegrants & Superdisintegrants, 6 Parenteral, 3 Co-Processed Excipients, 3 Granulation, 1 Solubilizers, 1 Thickeners and Stabilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 116 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 52 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

17 APIs, 9 FDF Dossiers, 2 Intermediates

PATENTS & EXCLUSIVITIES

13 US Patents, 1 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 5 Others

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USFDA APPLICATION NUMBER - 208313 / DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GEMCITABINE HYDROCHLORIDE(UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)	GEMCITABINE	10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1 \| 10mg in 1

Inactive Ingredients

Ingredient Name	Sun Pharmaceutical Industries, Inc.
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)

Setid 4e7e5088 D476 40e2 8cbd Dfeed4ddd166 Applno 208313 Form Solution Intravenous Dosage Eq 2000mg Base 200ml Eq 10mg Base Ml - Drug Product Composition: Gemcitabine

Gemcitabine

Gemcitabine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

100 API Suppliers

29 USDMF

26 CEP/COS

13 JDMF

9 EU WC

30 KDMF

18 NDC API

46 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

847 Drugs in Development

INTERMEDIATES

19 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

253 FDF Dossiers

92 FDA Orange Book

91 Europe

4 Canada

4 Australia

22 South Africa

40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

1 Gangwal Healthcare

1 Pfanstiehl

1 Kirsch Pharma

1 Actylis

1 BASF

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

1 Kerry

2 Microlex e.U

1 Pluviaendo

3 Roquette

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders

12 Chewable & Orodispersible Aids

10 Taste Masking

10 Direct Compression

7 Disintegrants & Superdisintegrants

6 Parenteral

3 Co-Processed Excipients

3 Granulation

1 Solubilizers

1 Thickeners and Stabilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow

116 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions

52 Regulatory FDF Prices

2 Annual Reports

MARKET PLACE

17 APIs

9 FDF Dossiers

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons