Zoledronic Acid | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Zoledronic Acid
South Africa

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Zoledronic Acid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 25 USDMF, 9 CEP/COS, 8 JDMF, 11 EU WC, 8 KDMF, 13 NDC API, 48 Listed Suppliers, $ API Reference Price

64 API Suppliers
25 USDMF
9 CEP/COS
8 JDMF
11 EU WC
8 KDMF
13 NDC API
48 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

222 FDF Dossiers, 56 FDA Orange Book, 67 Europe, 15 Canada, 24 Australia, 13 South Africa, 47 Listed Dossiers

222 FDF Dossiers
56 FDA Orange Book
67 Europe
15 Canada
24 Australia
13 South Africa
47 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAVENOUS - EQ 4MG BASE/100ML, INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - EQ 4MG BASE/100ML
INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 Faran Shimi Pharmaceutical, 1 Pfanstiehl, 4 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 Faran Shimi Pharmaceutical
1 Pfanstiehl
4 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 Direct Compression, 9 Taste Masking, 6 Parenteral, 4 Co-Processed Excipients, 3 Granulation, 3 Disintegrants & Superdisintegrants, 2 Controlled & Modified Release, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

17 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
9 Direct Compression
9 Taste Masking
6 Parenteral
4 Co-Processed Excipients
3 Granulation
3 Disintegrants & Superdisintegrants
2 Controlled & Modified Release
1 API Stability Enhancers
1 Thickeners and Stabilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 30 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
30 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 31 Finished Drug Prices, 1 Annual Reports

4 US Medicaid Prescriptions
31 Finished Drug Prices
1 Annual Reports

MARKET PLACE

15 APIs, 9 FDF Dossiers

15 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

11 US Patents, 7 Health Canada Patents

11 US Patents
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 4 Others

2 USP
4 Others

$ API Ref.Price (USD/KG) : 171,970 Xls

Filters

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13 All

01 1Accord Healthcare (Pty) Ltd

02 1Activo Health (Pty) Ltd

03 1Actor Pharma (Pty) Ltd

04 1Adcock Ingram Critical Care (Pty) Ltd

05 2Camox Pharmaceuticals (Pty) Ltd

06 1Cipla Medpro (Pty) Ltd

07 1Eurolab (Pty) Ltd

08 1Fresenius Kabi South Africa (Pty) Ltd

09 1Hetero Drugs South Africa (Pty) Ltd

10 1Novartis South Africa (Pty) Ltd

11 1Ranbaxy Pharmaceuticals (Pty) Ltd

12 1Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

13 All

01 1Zoledronic

02 10Zoledronic Acid

03 2Zoledronic acid

filter Dosage Form Reset all filters

13 All

01 8INF

02 3INJ

03 1POI

04 1POW

filter Brand Name Reset all filters

13 All

01 1Aclasta

02 1Austell Zoledronic Acid IV

03 1Eurodron

04 1ZOLEDRONIC ACID 4mg/5ml FRESENIUS

05 1ZOMABON

06 1Zobone

07 1Zoclasta 5mg/100ml

08 1Zolapor

09 1Zoldron

10 1Zoltero

11 1Zomedron

12 1Zometa 4 mg

13 1Zosteopor

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

Antibody Engineering

Not Confirmed

Accord Healthcare (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zoldron

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Activo Health (Pty) Ltd

Antibody Engineering

Not Confirmed

Activo Health (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zolapor

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Actor Pharma (Pty) Ltd

Antibody Engineering

Not Confirmed

Actor Pharma (Pty) Ltd

Antibody Engineering

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : ZOMABON

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Adcock Ingram Critical Care (Pty) Ltd

Antibody Engineering

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zosteopor

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Camox Pharmaceuticals (Pty) Ltd

Antibody Engineering

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

Antibody Engineering

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zoclasta 5mg/100ml

Dosage Form : INF

Dosage Strength : 5mg/100ml

Packaging : 100X1mg/100ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

06

Camox Pharmaceuticals (Pty) Ltd

Antibody Engineering

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Austell Zoledronic Acid IV

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

07

Cipla Medpro (Pty) Ltd

Antibody Engineering

Not Confirmed

Cipla Medpro (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zomedron

Dosage Form : POI

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Eurolab (Pty) Ltd

Antibody Engineering

Not Confirmed

Eurolab (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Eurodron

Dosage Form : INF

Dosage Strength : 4mg/5 ml

Packaging : 5X1mg/5 ml

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

Antibody Engineering

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic acid

Brand Name : ZOLEDRONIC ACID 4mg/5ml FRESENIUS

Dosage Form : INJ

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Hetero Drugs South Africa (Pty) Ltd

Antibody Engineering

Not Confirmed

Hetero Drugs South Africa (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Zoledronic Acid

Brand Name : Zoltero

Dosage Form : INF

Dosage Strength : 4mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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