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Rufinamide

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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 9 USDMF, 2 EU WC, 8 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

46 FDF Dossiers, 26 FDA Orange Book, 15 Europe, 5 Canada

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 7 SPI Pharma, 11 DKSH, 4 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 29 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 30 Thickeners and Stabilizers, 25 Controlled & Modified Release, 20 Direct Compression, 18 Film Formers & Plasticizers, 16 Granulation, 15 Topical, 14 Lubricants & Glidants, 13 Taste Masking, 12 Rheology Modifiers, 11 Solubilizers, 10 Co-Processed Excipients, 9 Disintegrants & Superdisintegrants, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

21 News #PharmaBuzz

21 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 13 Annual Reports

MARKET PLACE

1 APIs

1 APIs

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 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	Alivus Life Sciences	India	GLENMARK LIFE SCIENCES LTD	26209	RUFINAMIDE	2012-10-23	Active	II	Complete	2013-04-24	2012-11-06
28/03/2025	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INC	29034	RUFINAMIDE USP	2015-03-27	Active	II	Complete	2015-07-21	2015-03-16

Rufinamide

Rufinamide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

14 API Suppliers

9 USDMF

2 EU WC

8 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

46 FDF Dossiers

26 FDA Orange Book

15 Europe

5 Canada

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 40MG/ML

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 200MG

TABLET;ORAL - 400MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

7 SPI Pharma

11 DKSH

4 Faran Shimi Pharmaceutical

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

15 BASF

10 Corel Pharma Chem

4 DFE Pharma

2 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

29 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

24 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 The Dow Chemical Company

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders

49 Coating Systems & Additives

30 Thickeners and Stabilizers

25 Controlled & Modified Release

20 Direct Compression

18 Film Formers & Plasticizers

16 Granulation

15 Topical

14 Lubricants & Glidants

13 Taste Masking

12 Rheology Modifiers

11 Solubilizers

10 Co-Processed Excipients

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons