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Pramipexole Dihydrochloride

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ACTIVE PHARMA INGREDIENTS

46 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

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TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents

DIGITAL CONTENT

19 NEWS #PharmaBuzz

19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 290 Finished Drug Prices

MARKET PLACE

10 APIs

10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 17 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	18836	PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP	2005-10-06	Active	II	N/A
28/10/2024	Amino Chemicals	Malta	AMINO CHEMICALS LTD	18297	PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE	2005-04-21	Active	II	Complete	2019-04-12	2019-02-19

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

46 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

INTERMEDIATES

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

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**

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

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