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01 6ACCORD HEALTHCARE LIMITED

02 6AUROBINDO PHARMA ITALIA Srl

03 7Accord Healthcare Ltd.

04 7Accord Healthcare Slu

05 3Actavis Group PTC ehf

06 3AqVida GmbH

07 3Aurovitas Spain, Sau

08 2ELI LILLY ITALIA SpA

09 2Eli Lilly Norge AS

10 2Eugia Pharma (Malta) Limited

11 2Flynn Pharma Limited

12 6Fresenius Kabi Espa?a, Sau

13 2Gp Pharm Sa

14 3HOSPIRA ITALIA Srl

15 3Hikma Farmaceutica (Portugal) Sa

16 3Hospira UK Limited

17 3Koanaa Healthcare Gmbh

18 3Pfizer Sl

19 3Prasfarma Sl

20 3SANDOZ SpA

21 2SUN PHARMACEUTICAL IND.EU.B.V.

22 6Sun Pharmaceutical Ind. Europe BV

23 2Sun Pharmaceutical Industries (Europe) Bv

24 2TEVA ITALIA Srl

25 4The Fresenius Kabi Norge AS - Halden

26 3The Fresenius Kabi Oncology Plc

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PharmaCompass

01

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 10Ml 1 Units Parenteral Use

Dosage Strength : 1 vial soluz Chk 10 ml 100 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name :

Dosage Form : LYOPHILISATE FOR SOLUTION FOR INFUSION

Dosage Strength : 200MG

Packaging : Vial (Box)

Approval Date :

Application Number : 90242

Regulatory Info : Generic Dossier Available; MRP/DCP Possible

Registration Country : Germany

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04

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name :

Dosage Form : LYOPHILISATE FOR SOLUTION FOR INFUSION

Dosage Strength : 1000MG

Packaging : Vial (Box)

Approval Date :

Application Number : 90242

Regulatory Info : Generic Dossier Available; MRP/DCP Possible

Registration Country : Germany

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05

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name :

Dosage Form : LYOPHILISATE FOR SOLUTION FOR INFUSION

Dosage Strength : 2000MG

Packaging : Vial (Box)

Approval Date :

Application Number : 90644

Regulatory Info : Generic Dossier Available; MRP/DCP Possible

Registration Country : Germany

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06

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Gemcitabine

Brand Name : Gembin

Dosage Form : Gemcitabine 1.000Mg 25Ml 1 Units Parenteral Use

Dosage Strength : 1 vial EV 1 g 25 ml 40 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Gemcitabine

Brand Name : Gemzar

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle EV 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

PREP
Not Confirmed
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PREP
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle EV 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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