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Sifrol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 24 USDMF, 18 CEP/COS, 2 JDMF, 16 EU WC, 11 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

780 FDF Dossiers, 181 FDA Orange Book, 398 Europe, 33 Canada, 70 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TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 17 SPI Pharma, 9 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 5 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

60 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 35 Thickeners and Stabilizers, 29 Controlled & Modified Release, 26 Direct Compression, 22 Taste Masking, 22 Solubilizers, 18 Granulation, 16 Chewable & Orodispersible Aids, 16 Co-Processed Excipients, 14 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Film Formers & Plasticizers, 9 Topical, 7 Parenteral, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents

DIGITAL CONTENT

19 News #PharmaBuzz

19 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 290 Regulatory FDF Prices

MARKET PLACE

10 APIs

10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 17 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	18836	PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP	2005-10-06	Active	II	N/A
28/03/2025	Amino Chemicals	Malta	AMINO CHEMICALS LTD	18297	PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE	2005-04-21	Active	II	Complete	2019-04-12	2019-02-19

Sifrol

Sifrol

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers

24 USDMF

18 CEP/COS

2 JDMF

16 EU WC

11 KDMF

11 NDC API

26 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

780 FDF Dossiers

181 FDA Orange Book

398 Europe

33 Canada

70 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

17 SPI Pharma

9 DKSH

1 Pharm-RX Chemical

4 Faran Shimi Pharmaceutical

6 Boai NKY Pharmaceuticals Ltd

5 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

60 Fillers, Diluents & Binders

45 Coating Systems & Additives

35 Thickeners and Stabilizers

29 Controlled & Modified Release

26 Direct Compression

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