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Drug Approvals by the Medicines Control Council in South Africa containing Gemcitabine. Original Data : South African Medicines Price Registry

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Product

Gemcitabine
Cytosine
Acelarin
South Africa

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Gemcitabine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

74 API Suppliers, 31 USDMF, 25 CEP/COS, 12 JDMF, 13 EU WC, 31 KDMF, 18 NDC API, 40 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

254 Drugs in Development

254 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

19 API Suppliers

19 API Suppliers

FINISHED DOSAGE FORMULATIONS

245 FDF Dossiers, 88 FDA Orange Book, 89 Europe, 4 Canada, 4 Australia, 21 South Africa, 39 Listed Dossiers

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INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG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)

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

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

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

3 DATA COMPILATION #PharmaFlow, 101 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
101 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

2 US Medicaid Prescriptions
69 Finished Drug Prices
2 Annual Reports

MARKET PLACE

15 APIs, 9 FDF Dossiers, 2 Intermediates

15 APIs
9 FDF Dossiers
2 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 Others

3 EDQM
1 USP
3 Others

$ API Ref.Price (USD/KG) : 4,670 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

21 All

01 2Accord Healthcare (Pty) Ltd

02 2Cipla Medpro (Pty) Ltd

03 2Eli Lilly (SA) (Pty) Ltd

04 2Eurolab (Pty) Ltd

05 2Fresenius Kabi South Africa (Pty) Ltd

06 2Ranbaxy Pharmaceuticals (Pty) Ltd

07 4Sandoz SA (Pty) Ltd

08 1Teva Pharmaceuticals (Pty) Ltd

09 2Xixia Pharmaceuticals (Pty) Ltd

10 2Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

21 All

01 8Gemcitabine

02 9Gemcitabine Hydrochloride

03 2Gemcitabine hydrochloride

04 2gemcitabine hydrochloride

filter Dosage Form Reset all filters

21 All

01 6INF

02 12INJ

03 3POI

filter Brand Name Reset all filters

21 All

01 1Accord Gemcitabine 1g

02 1Accord Gemcitabine 200mg

03 1Cytigem 1g

04 1Cytigem 200mg

05 1GEMCITABINE 1g RTU FRESENIUS

06 1GEMCITABINE 200mg RTU FRESENIUS

07 2GEMCITABINE SANDOZ 40 mg/ mL

08 1Gemcitabine Teva 2000

09 1Gemtaz 1g

10 1Gemtaz 200mg

11 1Gemzar 1 g

12 1Gemzar 200 mg

13 1Mylan Gemcitabine 1 g

14 1Mylan Gemcitabine 200 mg

15 1Oncogem 1000

16 1Oncogem 200

17 1Rogem 1

18 1Rogem 200

19 1Sandoz Gemcitabine 1G IVI

20 1Sandoz Gemcitabine 200Mg IVI

DRL Gemcitabine

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

FNCE 2024

Not Confirmed

Accord Healthcare (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine hydrochloride

Brand Name : Accord Gemcitabine 1g

Dosage Form : INJ

Dosage Strength : 1000mg/50ml

Packaging : 50X1mg/50ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Accord Healthcare (Pty) Ltd

FNCE 2024

Not Confirmed

Accord Healthcare (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine hydrochloride

Brand Name : Accord Gemcitabine 200mg

Dosage Form : INJ

Dosage Strength : 200mg/10ml

Packaging : 10X1mg/10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cipla Medpro (Pty) Ltd

FNCE 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine

Brand Name : Oncogem 200

Dosage Form : POI

Dosage Strength : 200mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cipla Medpro (Pty) Ltd

FNCE 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine

Brand Name : Oncogem 1000

Dosage Form : POI

Dosage Strength : 1000mg

Packaging : 25X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Eli Lilly (SA) (Pty) Ltd

FNCE 2024

Not Confirmed

Eli Lilly (SA) (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Gemcitabine

Brand Name : Gemzar 200 mg

Dosage Form : INJ

Dosage Strength : 200mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

06

Eli Lilly (SA) (Pty) Ltd

FNCE 2024

Not Confirmed

Eli Lilly (SA) (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Gemcitabine

Brand Name : Gemzar 1 g

Dosage Form : INJ

Dosage Strength : 1g

Packaging : 25X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

07

Eurolab (Pty) Ltd

FNCE 2024

Not Confirmed

Eurolab (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine Hydrochloride

Brand Name : Cytigem 200mg

Dosage Form : INJ

Dosage Strength : 200mg/10ml

Packaging : 10X1mg/10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Eurolab (Pty) Ltd

FNCE 2024

Not Confirmed

Eurolab (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine Hydrochloride

Brand Name : Cytigem 1g

Dosage Form : INJ

Dosage Strength : 1g/50ml

Packaging : 50X1g/50ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Fresenius Kabi South Africa (Pty) Ltd

FNCE 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine Hydrochloride

Brand Name : GEMCITABINE 200mg RTU FRESENIUS

Dosage Form : INF

Dosage Strength : 200mg

Packaging : 5.26X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Fresenius Kabi South Africa (Pty) Ltd

FNCE 2024

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

FNCE 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Gemcitabine Hydrochloride

Brand Name : GEMCITABINE 1g RTU FRESENIUS

Dosage Form : INF

Dosage Strength : 1g

Packaging : 26.3X1g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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