Pramipexole Dihydrochloride | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Pramipexole Dihydrochloride
Australia

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Pramipexole Dihydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 24 USDMF, 18 CEP/COS, 2 JDMF, 17 EU WC, 11 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

52 API Suppliers
24 USDMF
18 CEP/COS
2 JDMF
17 EU WC
11 KDMF
11 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

838 FDF Dossiers, 181 FDA Orange Book, 475 Europe, 33 Canada, 56 Australia, 29 South Africa, 64 Listed Dossiers

838 FDF Dossiers
181 FDA Orange Book
475 Europe
33 Canada
56 Australia
29 South Africa
64 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TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or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, 17 SPI Pharma, 9 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 ACG Worldwide, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 10 BASF, 1 CD Formulation, 16 Corel Pharma Chem, 2 DFE Pharma, 7 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 11 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 34 Thickeners and Stabilizers, 26 Direct Compression, 24 Controlled & Modified Release, 22 Taste Masking, 22 Solubilizers, 18 Granulation, 18 Chewable & Orodispersible Aids, 15 Co-Processed Excipients, 14 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Topical, 8 Parenteral, 8 Film Formers & Plasticizers, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents

61 Fillers, Diluents & Binders
40 Coating Systems & Additives
34 Thickeners and Stabilizers
26 Direct Compression
24 Controlled & Modified Release
22 Taste Masking
22 Solubilizers
18 Granulation
18 Chewable & Orodispersible Aids
15 Co-Processed Excipients
14 Lubricants & Glidants
13 Disintegrants & Superdisintegrants
9 Topical
8 Parenteral
8 Film Formers & Plasticizers
7 API Stability Enhancers
7 Rheology Modifiers
5 Empty Capsules
5 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring Agents

DIGITAL CONTENT

20 News #PharmaBuzz

20 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 153 Regulatory FDF Prices

19 US Medicaid Prescriptions
153 Regulatory FDF Prices

MARKET PLACE

10 APIs

10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 15 Health Canada Patents

14 US Patents
15 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 16 Others

3 EDQM
2 USP
16 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 10,237 Xls

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56 All

01 7Alphapharm Pty Ltd

02 7Apotex Pty Ltd

03 21Arrow Pharma Pty Ltd

04 21Boehringer Ingelheim Pty Ltd

filter Active Ingredients Reset all filters

56 All

01 56Pramipexole

Dosage Form Reset all filters

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01 56Blank

filter Brand Name Reset all filters

56 All

01 7APO-Pramipexole

02 14SIMIPEX XR

03 7Sifrol

04 14Sifrol ER

05 2Simipex 0.125

06 3Simipex 0.25

07 2Simipex 1

08 7Simpral

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Product Main Page

01

Alphapharm Pty Ltd

OTS 2025

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Alphapharm Pty Ltd

OTS 2025

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : Simpral

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Packaging : 100

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Regulatory Info :

Registration Country : Australia

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02

Apotex Pty Ltd

OTS 2025

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Apotex Pty Ltd

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Registration Country : Australia

Pramipexole

Brand Name : APO-Pramipexole

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Packaging : 100

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03

Arrow Pharma Pty Ltd

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Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : SIMIPEX XR

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Packaging : 30

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Regulatory Info :

Registration Country : Australia

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04

Arrow Pharma Pty Ltd

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Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : SIMIPEX XR

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Packaging : 30

Approval Date :

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Regulatory Info :

Registration Country : Australia

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05

Arrow Pharma Pty Ltd

OTS 2025

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Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : Simipex 0.25

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Packaging : 100

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Arrow Pharma Pty Ltd

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Arrow Pharma Pty Ltd

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Pramipexole

Brand Name : SIMIPEX XR

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Packaging : 30

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Registration Country : Australia

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07

Boehringer Ingelheim Pty Ltd

OTS 2025

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Boehringer Ingelheim Pty Ltd

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : Sifrol ER

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Packaging : 30

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Registration Country : Australia

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08

Boehringer Ingelheim Pty Ltd

OTS 2025

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Boehringer Ingelheim Pty Ltd

OTS 2025

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Registration Country : Australia

Pramipexole

Brand Name : Sifrol ER

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Packaging : 30

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Regulatory Info :

Registration Country : Australia

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Boehringer Ingelheim Pty Ltd

OTS 2025

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Boehringer Ingelheim Pty Ltd

OTS 2025

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Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : Sifrol

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Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Boehringer Ingelheim Pty Ltd

OTS 2025

Not Confirmed

Boehringer Ingelheim Pty Ltd

OTS 2025

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Digital Content

Regulatory Info :

Registration Country : Australia

Pramipexole

Brand Name : Sifrol ER

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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