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Gemcitabine HCl

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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

1273 Drugs in Development

1273 Drugs in Development

INTERMEDIATES

19 Intermediate Suppliers

19 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

252 FDF Dossiers, 92 FDA Orange Book, 91 Europe, 4 Canada, 4 Australia, 22 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INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG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, 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 Thickeners and Stabilizers, 1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 115 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

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
19/09/2025	Dr. Reddy's Laboratories	India	M/s Dr.Reddys Laboratories Limited	WC-0039	Gemcitabine Hydrochloride USP/Ph. Eur	2025-06-20	2028-07-07	UNIT-I, Plot Nos. 137, 138, 145 & 146, Sri Venkateswara Co-operative Industrial Estate, Bollaram (Village), Jinnaram (Mandal), Sangareddy (Dist.), Telangana State, India
04/06/2025	Fresenius Kabi Oncology Limited	India	M/sFresenius Kabi Oncology Ltd	WC-0115	Gemcitabine Hydrochloride USP/Ph. Eur.	2022-09-16	2025-09-15	D-35, Industrial Area, Kalyani, Dist-Nadia-741235, West Bengal

Gemcitabine HCl

Gemcitabine HCl

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Browse all information

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

1273 Drugs in Development

INTERMEDIATES

19 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

252 FDF Dossiers

92 FDA Orange Book

91 Europe

4 Canada

4 Australia

22 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

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 Thickeners and Stabilizers

1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow

115 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

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