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Gemcitabine

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 31 USDMF, 25 CEP/COS, 12 JDMF, 13 EU WC, 31 KDMF, 18 NDC API, 39 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

262 Drugs in Development

262 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

245 FDF Dossiers, 88 FDA Orange Book, 89 Europe, 4 Canada, 4 Australia, 21 South Africa, 39 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INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG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, 12 SPI Pharma, 1 Pfanstiehl, 1 Actylis, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 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, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 5 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Co-Processed Excipients, 3 Granulation, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 101 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 69 Finished Drug Prices, 2 Annual Reports

MARKET PLACE

16 APIs, 9 FDF Dossiers, 2 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	18857	GEMCITABINE HYDROCHLORIDE USP	2005-10-11	Active	II	Complete	2016-06-27	2016-06-06
28/10/2024	Arch Pharmalabs	India	ARCH PHARMALABS LTD	23633	GEMCITABINE HYDROCHLORIDE USP	2010-03-31	Active	II	N/A

Gemcitabine

Gemcitabine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

31 USDMF

25 CEP/COS

12 JDMF

13 EU WC

31 KDMF

18 NDC API

39 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

262 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

245 FDF Dossiers

88 FDA Orange Book

89 Europe

4 Canada

4 Australia

21 South Africa

39 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

12 SPI Pharma

1 Pfanstiehl

1 Actylis

1 BASF

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

2 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

10 Chewable & Orodispersible Aids

9 Taste Masking

9 Direct Compression

5 Parenteral

3 Disintegrants & Superdisintegrants

3 Co-Processed Excipients

3 Granulation

1 API Stability Enhancers

1 Thickeners and Stabilizers

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow

101 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

69 Finished Drug Prices

2 Annual Reports

MARKET PLACE

16 APIs

9 FDF Dossiers

2 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

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