Rufinamide

ACCESS ALL DATA, CHEMISTRY

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 Intermediates Suppliers

2 Intermediates 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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG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, 2 Seqens, 7 DKSH, 4 Faran Shimi Pharmaceutical, 11 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

59 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 28 Direct Compression, 27 Thickeners and Stabilizers, 26 Controlled & Modified Release, 18 Film Formers & Plasticizers, 16 Granulation, 15 Topical, 15 Lubricants & Glidants, 14 Co-Processed Excipients, 13 Taste Masking, 11 Disintegrants & Superdisintegrants, 11 Solubilizers, 8 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 7 Parenteral, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 15 Finished Drug 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

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USFDA APPLICATION NUMBER - 21911 / DOSAGE - TABLET;ORAL - 400MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RUFINAMIDE(UNII: WFW942PR79) (RUFINAMIDE - UNII:WFW942PR79)	RUFINAMIDE	200mg \| 400mg \| 40mg in 1

Inactive Ingredients

Ingredient Name	Eisai Inc.	Glenmark Pharmaceuticals Inc., USA	Lupin Pharmaceuticals, Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
DIMETHICONE(92RU3N3Y1O)
FERRIC OXIDE RED(1K09F3G675)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(S38J6RZN16)
HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
ORANGE(5EVU04N5QU)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POTASSIUM SORBATE(1VPU26JZZ4)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Rufinamide

Rufinamide

Rufinamide

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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 Intermediates 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

2 Seqens

7 DKSH

4 Faran Shimi Pharmaceutical

11 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

59 Fillers, Diluents & Binders

49 Coating Systems & Additives

28 Direct Compression

27 Thickeners and Stabilizers

26 Controlled & Modified Release

18 Film Formers & Plasticizers

16 Granulation

15 Topical

15 Lubricants & Glidants

14 Co-Processed Excipients

13 Taste Masking

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