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

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Product

Leuprolide
Leuprolide Mesylate
Enantone 1
South Africa

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Bora Pharmaceuticals- Making success more certain.

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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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Leuprolide

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 28 USDMF, 15 CEP/COS, 5 JDMF, 4 EU WC, 9 KDMF, 60 NDC API, 21 Listed Suppliers, $ API Reference Price

44 API Suppliers
28 USDMF
15 CEP/COS
5 JDMF
4 EU WC
9 KDMF
60 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers, 33 FDA Orange Book, 75 Europe, 11 Canada, 11 Australia, 9 South Africa, 37 Listed Dossiers

176 FDF Dossiers
33 FDA Orange Book
75 Europe
11 Canada
11 Australia
9 South Africa
37 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- 15MG, POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAMUSCULAR - 30MG, POWDER;INTRAMUSCULAR - 45MG, POWDER;INTRAMUSCULAR - 7.5MG, POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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

2 DATA COMPILATION #PharmaFlow, 33 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
33 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

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

13 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) : 128,417 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

FDF Dossiers
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South Africa
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01

AbbVie (Pty) Ltd

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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

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02

AbbVie (Pty) Ltd

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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

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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

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04

Eurolab (Pty) Ltd

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Eurolab (Pty) Ltd

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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

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05

Eurolab (Pty) Ltd

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Eurolab (Pty) Ltd

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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

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Corporate PDF

06

Key Oncologics (Pty) Ltd

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Key Oncologics (Pty) Ltd

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Digital Content

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

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Corporate PDF

07

Key Oncologics (Pty) Ltd

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Not Confirmed

Key Oncologics (Pty) Ltd

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Digital Content

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

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08

Key Oncologics (Pty) Ltd

Discovery on Target

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Key Oncologics (Pty) Ltd

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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

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09

Sandoz SA (Pty) Ltd

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Sandoz SA (Pty) Ltd

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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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