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Drug Approvals by the Medicines Control Council in South Africa containing AM20060780. Original Data : South African Medicines Price Registry

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Product

AM20060780
South Africa

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AM20060780

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 37 USDMF, 10 EU WC, 8 KDMF, 32 NDC API, 34 Listed Suppliers, $ API Reference Price

58 API Suppliers
37 USDMF
10 EU WC
8 KDMF
32 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers, 130 FDA Orange Book, 85 Europe, 12 Canada, 2 Australia, 17 South Africa, 18 Listed Dossiers

264 FDF Dossiers
130 FDA Orange Book
85 Europe
12 Canada
2 Australia
17 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG
TABLET, EXTENDED RELEASE;ORAL - 100MG
TABLET, EXTENDED RELEASE;ORAL - 150MG
TABLET, EXTENDED RELEASE;ORAL - 200MG
TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 150MG
TABLET, EXTENDED RELEASE;ORAL - 300MG
TABLET, EXTENDED RELEASE;ORAL - 450MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 2 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 14 DKSH, 2 Jai Radhe Sales, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 4 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 2 Clariant, 16 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 15 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 21 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

105 Fillers, Diluents & Binders, 80 Coating Systems & Additives, 51 Controlled & Modified Release, 48 Direct Compression, 36 Solubilizers, 31 Lubricants & Glidants, 30 Granulation, 30 Thickeners and Stabilizers, 29 Film Formers & Plasticizers, 27 Taste Masking, 23 Parenteral, 21 Topical, 19 Co-Processed Excipients, 18 Disintegrants & Superdisintegrants, 17 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

105 Fillers, Diluents & Binders
80 Coating Systems & Additives
51 Controlled & Modified Release
48 Direct Compression
36 Solubilizers
31 Lubricants & Glidants
30 Granulation
30 Thickeners and Stabilizers
29 Film Formers & Plasticizers
27 Taste Masking
23 Parenteral
21 Topical
19 Co-Processed Excipients
18 Disintegrants & Superdisintegrants
17 Chewable & Orodispersible Aids
11 Emulsifying Agents
8 API Stability Enhancers
7 Rheology Modifiers
5 Surfactant & Foaming Agents
5 Coloring Agents
5 Empty Capsules
4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 90 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
90 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 62 Finished Drug Prices, 10 Annual Reports

6 US Medicaid Prescriptions
62 Finished Drug Prices
10 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

10 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

22 US Patents, 30 Health Canada Patents

22 US Patents
30 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 8 Others

5 USP
8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 63 Xls

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17 All

01 1Acino Pharma (Pty) Ltd

02 1Adcock Ingram Limited

03 4GlaxoSmithKline South Africa (Pty) Limited

04 2GlaxoSmithKline South Africa Pty Ltd

05 1Litha Pharma (Pty) Ltd

06 2Pharma Dynamics (Pty) Ltd

07 4Ranbaxy Pharmaceuticals (Pty) Ltd

08 2Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

17 All

01 4BUPROPION HCL

02 1Bupropion

03 9Bupropion Hydrochloride

04 3Bupropion Hydrochloride.

filter Dosage Form Reset all filters

17 All

01 4FCT

02 1SRT

03 11TAB

04 1Tab

filter Brand Name Reset all filters

17 All

01 1BUDEP XR 150

02 1BUDEP XR 300

03 1Bupropion XR 150 Adco

04 1Bupyra XL 150

05 1Bupyra XL 300

06 1Contrave

07 1Nicolift

08 1PRODYNA 150 mg XR

09 1PRODYNA 300 mg XR

10 1Voxra XL 150

11 1Voxra XL 300

12 1WELDEP XR 150

13 1WELDEP XR 300

14 1Wellbutrin SR

15 1Wellbutrin XL 150

16 1Wellbutrin XL 300

17 1Zyban

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

List of Suppliers

Product Main Page

01

Litha Pharma (Pty) Ltd

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Litha Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : Nicolift

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Bupropion XR 150 Adco

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Bupropion Hydrochloride.

Brand Name : Zyban

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : Wellbutrin SR

Dosage Form : SRT

Dosage Strength : 150mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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GlaxoSmithKline South Africa (Pty) Limit...

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Regulatory Info : Originator

Registration Country : South Africa

Bupropion Hydrochloride.

Brand Name : Wellbutrin XL 150

Dosage Form : TAB

Dosage Strength : 150 mg

Packaging : 30X1 mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

GlaxoSmithKline South Africa (Pty) Limit...

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Regulatory Info : Originator

Registration Country : South Africa

Bupropion Hydrochloride.

Brand Name : Wellbutrin XL 300

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Pharma Dynamics (Pty) Ltd

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Pharma Dynamics (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : PRODYNA 150 mg XR

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Acino Pharma (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : Contrave

Dosage Form : Tab

Dosage Strength : 90mg

Packaging : 112X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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09

GlaxoSmithKline South Africa Pty Ltd

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GlaxoSmithKline South Africa Pty Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : Voxra XL 300

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

GlaxoSmithKline South Africa Pty Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Bupropion Hydrochloride

Brand Name : Voxra XL 150

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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Website

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