Bupropion Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Bupropion Hydrochloride
South Africa

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Bupropion Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 37 USDMF, 11 EU WC, 10 KDMF, 34 NDC API, 33 Listed Suppliers, $ API Reference Price

73 API Suppliers
37 USDMF
11 EU WC
10 KDMF
34 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

32 Drugs in Development

32 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

273 FDF Dossiers, 136 FDA Orange Book, 85 Europe, 12 Canada, 2 Australia, 19 South Africa, 19 Listed Dossiers

273 FDF Dossiers
136 FDA Orange Book
85 Europe
12 Canada
2 Australia
19 South Africa
19 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG,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- 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 7 Evonik, 2 Rochem International Inc, 20 SPI Pharma, 17 DKSH, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Capital Farma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 35 BASF, 1 CD Formulation, 2 Clariant, 16 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 13 Ideal Cures, 3 Ingredion Pharma Solutions, 39 Kerry, 2 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 21 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 2 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, 9 Sigachi Industries, 2 Silverline Chemicals, 4 The Dow Chemical Company, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

100 Fillers, Diluents & Binders, 79 Coating Systems & Additives, 50 Controlled & Modified Release, 40 Solubilizers, 37 Direct Compression, 34 Thickeners and Stabilizers, 30 Granulation, 29 Lubricants & Glidants, 29 Taste Masking, 28 Film Formers & Plasticizers, 23 Topical, 21 Co-Processed Excipients, 20 Parenteral, 17 Chewable & Orodispersible Aids, 17 Disintegrants & Superdisintegrants, 10 Rheology Modifiers, 10 Emulsifying Agents, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

100 Fillers, Diluents & Binders
79 Coating Systems & Additives
50 Controlled & Modified Release
40 Solubilizers
37 Direct Compression
34 Thickeners and Stabilizers
30 Granulation
29 Lubricants & Glidants
29 Taste Masking
28 Film Formers & Plasticizers
23 Topical
21 Co-Processed Excipients
20 Parenteral
17 Chewable & Orodispersible Aids
17 Disintegrants & Superdisintegrants
10 Rheology Modifiers
10 Emulsifying Agents
7 API Stability Enhancers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

95 News #PharmaBuzz

95 News #PharmaBuzz

GLOBAL SALES INFORMATION

58 US Medicaid Prescriptions, 62 Regulatory FDF Prices, 10 Annual Reports

58 US Medicaid Prescriptions
62 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

12 APIs, 2 FDF Dossiers

12 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 US Patents, 30 Health Canada Patents

20 US Patents
30 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 16 Others

4 USP
16 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 62 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

19 All

01 1Acino Pharma (Pty) Ltd

02 1Adcock Ingram Limited

03 2Dr Reddy's Laboratories (Pty) Ltd

04 4GlaxoSmithKline South Africa (Pty) Limited

05 2GlaxoSmithKline South Africa Pty Ltd

06 1Litha Pharma (Pty) Ltd

07 2Pharma Dynamics (Pty) Ltd

08 4Ranbaxy Pharmaceuticals (Pty) Ltd

09 2Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

19 All

01 4BUPROPION HCL

02 2BUPROPION HYDROCHLORIDE

03 1Bupropion

04 9Bupropion Hydrochloride

05 3Bupropion Hydrochloride.

filter Dosage Form Reset all filters

19 All

01 4FCT

02 1SRT

03 13TAB

04 1Tab

filter Brand Name Reset all filters

19 All

01 1BUDEP XR 150

02 1BUDEP XR 300

03 1BUPROPION 150 XL DRL

04 1BUPROPION 300 XL DRL

05 1Bupropion XR 150 Adco

06 1Bupyra XL 150

07 1Bupyra XL 300

08 1Contrave

09 1Nicolift

10 1PRODYNA 150 mg XR

11 1PRODYNA 300 mg XR

12 1Voxra XL 150

13 1Voxra XL 300

14 1WELDEP XR 150

15 1WELDEP XR 300

16 1Wellbutrin SR

17 1Wellbutrin XL 150

18 1Wellbutrin XL 300

19 1Zyban

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

BIO Asia-Taiwan

Not Confirmed

Adcock Ingram Limited

BIO Asia-Taiwan

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

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Digital Content

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

Digital Content

Corporate PDF

05

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa (Pty) Limit...

BIO Asia-Taiwan

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Acino Pharma (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

Acino Pharma (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

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Virtual Booth

Digital Content

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

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Dr Reddy's Laboratories (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

Dr Reddy's Laboratories (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HYDROCHLORIDE

Brand Name : BUPROPION 150 XL DRL

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Dr Reddy's Laboratories (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

Dr Reddy's Laboratories (Pty) Ltd

Country

BIO Asia-Taiwan

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HYDROCHLORIDE

Brand Name : BUPROPION 300 XL DRL

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

GlaxoSmithKline South Africa Pty Ltd

Country

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa Pty Ltd

Country

BIO Asia-Taiwan

Not Confirmed

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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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

GlaxoSmithKline South Africa Pty Ltd

Country

BIO Asia-Taiwan

Not Confirmed

GlaxoSmithKline South Africa Pty Ltd

Country

BIO Asia-Taiwan

Not Confirmed

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Digital Content

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

Corporate PDF

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