Pramipexole Dihydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Pramipexole Dihydrochloride
South Africa

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Pramipexole Dihydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 24 USDMF, 18 CEP/COS, 2 JDMF, 17 EU WC, 10 KDMF, 12 NDC API, 25 Listed Suppliers, $ API Reference Price

45 API Suppliers
24 USDMF
18 CEP/COS
2 JDMF
17 EU WC
10 KDMF
12 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

751 FDF Dossiers, 181 FDA Orange Book, 398 Europe, 33 Canada, 41 Australia, 29 South Africa, 69 Listed Dossiers

751 FDF Dossiers
181 FDA Orange Book
398 Europe
33 Canada
41 Australia
29 South Africa
69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 16 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 16 Corel Pharma Chem, 2 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 18 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 35 Thickeners and Stabilizers, 33 Direct Compression, 30 Controlled & Modified Release, 22 Taste Masking, 21 Solubilizers, 19 Co-Processed Excipients, 18 Granulation, 15 Chewable & Orodispersible Aids, 15 Lubricants & Glidants, 11 Disintegrants & Superdisintegrants, 9 Topical, 9 Film Formers & Plasticizers, 7 Parenteral, 7 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

64 Fillers, Diluents & Binders
45 Coating Systems & Additives
35 Thickeners and Stabilizers
33 Direct Compression
30 Controlled & Modified Release
22 Taste Masking
21 Solubilizers
19 Co-Processed Excipients
18 Granulation
15 Chewable & Orodispersible Aids
15 Lubricants & Glidants
11 Disintegrants & Superdisintegrants
9 Topical
9 Film Formers & Plasticizers
7 Parenteral
7 API Stability Enhancers
5 Emulsifying Agents
5 Empty Capsules
4 Coloring Agents
4 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

19 NEWS #PharmaBuzz

19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 290 Finished Drug Prices

2 US Medicaid Prescriptions
290 Finished Drug Prices

MARKET PLACE

10 APIs

10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 17 Health Canada Patents

14 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 17 Others

3 EDQM
3 USP
17 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 11,303 Xls

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29 All

01 3Pharmacare Limited, Woodmead

02 3Gulf Drug Company (Pty) Ltd

03 8Ingelheim Pharmaceuticals (Pty) Ltd

04 3Mylan (Pty) Ltd

05 3Ranbaxy S.A (Pty) Ltd

06 2Sandoz SA (Pty) Ltd

07 4Teva Pharmaceuticals (Pty) Ltd

08 3Thebe Medicare (Pty) Ltd

filter Active Ingredients Reset all filters

29 All

01 4PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

02 9Pramipexole

03 13Pramipexole Dihydrochloride Monohydrate

04 3Pramipexole dihydrochloride monohydrate

filter Dosage Form Reset all filters

29 All

01 29TAB

filter Brand Name Reset all filters

29 All

01 1Mylan Pramipexole 0.125 mg

02 1Mylan Pramipexole 0.25 mg

03 1Mylan Pramipexole 1 mg

04 1Oxpola 0,125 mg

05 1Oxpola 0,25 mg

06 1Oxpola 1,0 mg

07 1PEXASP 0.125mg

08 1PEXASP 0.25mg

09 1PEXASP 1mg

10 1PRAMIPEXOLE ER 0,375 TEVA

11 1PRAMIPEXOLE ER 0,75 TEVA

12 1PRAMIPEXOLE ER 1,5 TEVA

13 1PRAMIPEXOLE ER 3 TEVA

14 1Pazoram 1,0

15 1Pazoram 0,125

16 1Pazoram 0,25

17 1Pexola 0.125 mg

18 1Pexola 0.25 mg

19 1Pexola 1.0 mg

20 1Pexola ER 0,375 mg

21 1Pexola ER 0,75 mg

22 1Pexola ER 1,5 mg

23 1Pexola ER 3,0 mg

24 1Pexola ER 4,5 mg

25 1Prames 0.25

26 1Pramex 0.125

27 1Pramex 1.0

28 1Pramiola 0,125

29 1Pramiola 0,25

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pramipexole

Brand Name : PEXASP 0.25mg

Dosage Form : TAB

Dosage Strength : 0.25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Pramipexole

Brand Name : PEXASP 0.125mg

Dosage Form : TAB

Dosage Strength : 0.125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Pramipexole

Brand Name : PEXASP 1mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Portfolio PDF

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04

Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Pexola ER 4,5 mg

Dosage Form : TAB

Dosage Strength : 4.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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05

Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Pexola ER 0,375 mg

Dosage Form : TAB

Dosage Strength : 0.375mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Pexola ER 0,75 mg

Dosage Form : TAB

Dosage Strength : 0.75mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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07

Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Ingelheim Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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Regulatory Info : Originator

Registration Country : South Africa

Pramipexole

Brand Name : Pexola 1.0 mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Gulf Drug Company (Pty) Ltd

Pharma, Lab & Chemical Expo

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Gulf Drug Company (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Oxpola 0,125 mg

Dosage Form : TAB

Dosage Strength : 0.125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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09

Gulf Drug Company (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Gulf Drug Company (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Oxpola 0,25 mg

Dosage Form : TAB

Dosage Strength : 0.25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Gulf Drug Company (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Gulf Drug Company (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pramipexole Dihydrochloride Monohydrate

Brand Name : Oxpola 1,0 mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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