Leuprolide Acetate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Leuprolide Acetate
South Africa

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Leuprolide Acetate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 29 USDMF, 15 CEP/COS, 5 JDMF, 4 EU WC, 10 KDMF, 60 NDC API, 21 Listed Suppliers, $ API Reference Price

45 API Suppliers
29 USDMF
15 CEP/COS
5 JDMF
4 EU WC
10 KDMF
60 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

178 FDF Dossiers, 34 FDA Orange Book, 75 Europe, 11 Canada, 11 Australia, 9 South Africa, 38 Listed Dossiers

178 FDF Dossiers
34 FDA Orange Book
75 Europe
11 Canada
11 Australia
9 South Africa
38 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAMUSCULAR - 11.25MG, POWDER;INTRAMUSCULAR - 15MG, POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAMUSCULAR - 30MG, POWDER;INTRAMUSCULAR - 45MG, POWDER;INTRAMUSCULAR - 7.5MG, POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

POWDER;INTRAMUSCULAR - 11.25MG
POWDER;INTRAMUSCULAR - 15MG
POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INTRAMUSCULAR - 30MG
POWDER;INTRAMUSCULAR - 45MG
POWDER;INTRAMUSCULAR - 7.5MG
POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 3 Actylis, 1 Finar

1 Nanjing Well Pharmaceutical
3 Actylis
1 Finar

EXCIPIENTS BY APPLICATIONS

3 Parenteral, 2 Topical, 1 Solubilizers

3 Parenteral
2 Topical
1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 38 Finished Drug Prices, 21 Annual Reports

4 US Medicaid Prescriptions
38 Finished Drug Prices
21 Annual Reports

MARKET PLACE

9 APIs, 7 FDF Dossiers

9 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 10 Health Canada Patents

14 US Patents
1 US Exclusivities
10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 JP, 2 Others

2 EDQM
1 USP
1 JP
2 Others

$ API Ref.Price (USD/KG) : 128,089 Xls

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9 All

01 3AbbVie (Pty) Ltd

02 2Eurolab (Pty) Ltd

03 3Key Oncologics (Pty) Ltd

04 1Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

9 All

01 1LEUPROLIDE ACETATE

02 3Leuprolide

03 1Leuprolide Acetate

04 2Leuprolide acetate

05 2Leuprorelin

filter Dosage Form Reset all filters

9 All

01 1IMP

02 8INJ

filter Brand Name Reset all filters

9 All

01 1Eligard 22.5mg

02 1Eligard 45mg

03 1Eligard 7.5mg

04 1LEUPROLIDE HEXAL 5

05 1Lucrin

06 1Lucrin 11.25

07 1Lucrin 3.75

08 1Prinolid 11,25

09 1Prinolid 3,75

Bachem Leuprolide Acetate

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Product Main Page

01

AbbVie (Pty) Ltd

Medlab Asia & Asia Health

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Leuprorelin

Brand Name : Lucrin

Dosage Form : INJ

Dosage Strength : 5mg/ml

Packaging : 2.8X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Abbvie Company Banner

Product Web Link

Digital Content

Corporate PDF

02

AbbVie (Pty) Ltd

Medlab Asia & Asia Health

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Regulatory Info : Generic

Registration Country : South Africa

Leuprorelin

Brand Name : Lucrin 3.75

Dosage Form : INJ

Dosage Strength : 3.75mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

AbbVie (Pty) Ltd

Medlab Asia & Asia Health

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Regulatory Info : Generic

Registration Country : South Africa

Leuprolide Acetate

Brand Name : Lucrin 11.25

Dosage Form : INJ

Dosage Strength : 11.25mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Abbvie Company Banner

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04

Eurolab (Pty) Ltd

Medlab Asia & Asia Health

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Eurolab (Pty) Ltd

Medlab Asia & Asia Health

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Regulatory Info : Generic

Registration Country : South Africa

Leuprolide acetate

Brand Name : Prinolid 11,25

Dosage Form : INJ

Dosage Strength : 11.25mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

05

Eurolab (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Eurolab (Pty) Ltd

Medlab Asia & Asia Health

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Regulatory Info : Generic

Registration Country : South Africa

Leuprolide acetate

Brand Name : Prinolid 3,75

Dosage Form : INJ

Dosage Strength : 3.75mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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06

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Eligard 7.5mg

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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07

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Eligard 22.5mg

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

08

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Key Oncologics (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Eligard 45mg

Dosage Form : INJ

Dosage Strength : 45mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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09

Sandoz SA (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Sandoz SA (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

LEUPROLIDE ACETATE

Brand Name : LEUPROLIDE HEXAL 5

Dosage Form : IMP

Dosage Strength : 5mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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