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

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Octreotide Acetate
South Africa

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Octreotide Acetate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 27 USDMF, 6 CEP/COS, 4 JDMF, 5 EU WC, 1 KDMF, 20 NDC API, 25 Listed Suppliers, $ API Reference Price

44 API Suppliers
27 USDMF
6 CEP/COS
4 JDMF
5 EU WC
1 KDMF
20 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

FINISHED DOSAGE FORMULATIONS

238 FDF Dossiers, 61 FDA Orange Book, 92 Europe, 11 Canada, 48 Australia, 8 South Africa, 18 Listed Dossiers

238 FDF Dossiers
61 FDA Orange Book
92 Europe
11 Canada
48 Australia
8 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML, INJECTABLE;INJECTION - EQ 0.1MG BASE/ML, INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.5MG BASE/ML, INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;SUBCUTANEOUS - 7MG/2.8ML (2.5MG/ML)

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML
INJECTABLE;INJECTION - EQ 0.1MG BASE/ML
INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 0.5MG BASE/ML
INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;SUBCUTANEOUS - 7MG/2.8ML (2.5MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Faran Shimi Pharmaceutical, 1 Pfanstiehl, 2 Actylis, 1 BASF, 1 Finar, 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
13 SPI Pharma
1 Faran Shimi Pharmaceutical
1 Pfanstiehl
2 Actylis
1 BASF
1 Finar
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, 7 Parenteral, 4 Co-Processed Excipients, 3 Disintegrants & Superdisintegrants, 3 Granulation, 2 API Stability Enhancers, 1 Thickeners and Stabilizers, 1 Topical

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 38 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 79 Finished Drug Prices, 10 Annual Reports

3 US Medicaid Prescriptions
79 Finished Drug Prices
10 Annual Reports

MARKET PLACE

15 APIs, 16 FDF Dossiers

15 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

15 US Patents, 1 US Exclusivities

15 US Patents
1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 USP, 6 Others

2 USP
6 Others

$ API Ref.Price (USD/KG) : 289,821 Xls

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8 All

01 6Novartis South Africa (Pty) Ltd

02 2Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 2OCTREOTIDE

02 6Octreotide

filter Dosage Form Reset all filters

8 All

01 2INF

02 6INJ

filter Brand Name Reset all filters

8 All

01 1OCTREOTIDE TEVA 20

02 1OCTREOTIDE TEVA 30

03 2Sandostatin

04 1Sandostatin 1Mg/5Ml Injection

05 1Sandostatin Lar 10Mg

06 1Sandostatin Lar 20Mg

07 1Sandostatin Lar 30Mg

Bachem Octreotide Acetate

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01

Teva Pharmaceuticals (Pty) Ltd

Fi Europe 2024

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Fi Europe 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : OCTREOTIDE TEVA 20

Dosage Form : INF

Dosage Strength : 20MG/2ML

Packaging : 2X1MG/2ML

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Digital Content

Corporate PDF

02

Teva Pharmaceuticals (Pty) Ltd

Fi Europe 2024

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Fi Europe 2024

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : OCTREOTIDE TEVA 30

Dosage Form : INF

Dosage Strength : 30MG/2ML

Packaging : 2X1MG/2ML

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Digital Content

Corporate PDF

03

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin Lar 10Mg

Dosage Form : INJ

Dosage Strength : 10mg

Packaging : 2.5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin Lar 20Mg

Dosage Form : INJ

Dosage Strength : 20mg

Packaging : 2.5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

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Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin Lar 30Mg

Dosage Form : INJ

Dosage Strength : 30mg

Packaging : 2.5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

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Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin

Dosage Form : INJ

Dosage Strength : 0.05mg/ml

Packaging : 1X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

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Fi Europe 2024

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin

Dosage Form : INJ

Dosage Strength : 0.1mg/ml

Packaging : 1X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

Fi Europe 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Sandostatin 1Mg/5Ml Injection

Dosage Form : INJ

Dosage Strength : 1mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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