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

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

75 API Suppliers, 37 USDMF, 12 EU WC, 10 KDMF, 33 NDC API, 35 Listed Suppliers, $ API Reference Price

75 API Suppliers
37 USDMF
12 EU WC
10 KDMF
33 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

141 Drugs in Development

141 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

210 FDF Dossiers, 136 FDA Orange Book, 43 Europe, 2 Canada, 2 Australia, 8 South Africa, 19 Listed Dossiers

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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG,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- 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 3 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Capital Farma, 6 Kirsch Pharma, 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, 26 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

85 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 45 Controlled & Modified Release, 43 Direct Compression, 40 Solubilizers, 37 Thickeners and Stabilizers, 35 Granulation, 29 Taste Masking, 29 Lubricants & Glidants, 28 Film Formers & Plasticizers, 24 Parenteral, 23 Topical, 19 Chewable & Orodispersible Aids, 17 Disintegrants & Superdisintegrants, 13 Co-Processed Excipients, 11 Emulsifying Agents, 10 Rheology Modifiers, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

85 Fillers, Diluents & Binders
76 Coating Systems & Additives
45 Controlled & Modified Release
43 Direct Compression
40 Solubilizers
37 Thickeners and Stabilizers
35 Granulation
29 Taste Masking
29 Lubricants & Glidants
28 Film Formers & Plasticizers
24 Parenteral
23 Topical
19 Chewable & Orodispersible Aids
17 Disintegrants & Superdisintegrants
13 Co-Processed Excipients
11 Emulsifying Agents
10 Rheology Modifiers
7 API Stability Enhancers
6 Surfactant & Foaming Agents
5 Coloring Agents
5 Empty Capsules
4 Vegetarian Capsules

DIGITAL CONTENT

95 News #PharmaBuzz

95 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

58 US Medicaid Prescriptions
58 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

12 APIs, 2 FDF Dossiers

12 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 US Patents, 26 Health Canada Patents

20 US Patents
26 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 25 Others

4 USP
25 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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

Filters

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filter Applicant Reset all filters

8 All

01 1Adcock Ingram Limited

02 3GlaxoSmithKline South Africa (Pty) Limited

03 4Ranbaxy Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 4BUPROPION HCL

02 1Bupropion

03 3Bupropion Hydrochloride.

filter Dosage Form Reset all filters

8 All

01 4FCT

02 4TAB

filter Brand Name Reset all filters

8 All

01 1BUDEP XR 150

02 1BUDEP XR 300

03 1Bupropion XR 150 Adco

04 1WELDEP XR 150

05 1WELDEP XR 300

06 1Wellbutrin XL 150

07 1Wellbutrin XL 300

08 1Zyban

List of Suppliers

Product Main Page

01

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

Portfolio PDF

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Corporate PDF

02

GlaxoSmithKline South Africa (Pty) Limit...

PREP

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GlaxoSmithKline South Africa (Pty) Limit...

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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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03

GlaxoSmithKline South Africa (Pty) Limit...

PREP

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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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04

GlaxoSmithKline South Africa (Pty) Limit...

Luxepack

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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 300

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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05

Ranbaxy Pharmaceuticals (Pty) Ltd

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Ranbaxy Pharmaceuticals (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HCL

Brand Name : WELDEP XR 150

Dosage Form : FCT

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Ranbaxy Pharmaceuticals (Pty) Ltd

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Ranbaxy Pharmaceuticals (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HCL

Brand Name : WELDEP XR 300

Dosage Form : FCT

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Ranbaxy Pharmaceuticals (Pty) Ltd

PREP

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

PREP

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HCL

Brand Name : BUDEP XR 150

Dosage Form : FCT

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

08

Ranbaxy Pharmaceuticals (Pty) Ltd

PREP

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

PREP

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

BUPROPION HCL

Brand Name : BUDEP XR 300

Dosage Form : FCT

Dosage Strength : 300mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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