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Approved Drug Products containing Rufinamide listed in the FDA Orange Book. Original Data : FDA Website

Client Email

Product

Rufinamide
FDA Orange Book

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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Rufinamide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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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

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

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

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

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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG

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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

58 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 Lubricants & Glidants, 15 Topical, 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 Soft Gelatin, 1 Surfactant & Foaming Agents

58 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 Lubricants & Glidants
15 Topical
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 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 15 Finished Drug Prices, 13 Annual Reports

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

3 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,847 Xls

Filters

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26 All

01 1ALKEM LABS LTD

02 3AUROBINDO PHARMA

03 1BIONPHARMA

04 1CHARTWELL RX

05 4EISAI INC

06 2GLENMARK PHARMS LTD

07 3HETERO LABS LTD III

08 3HIKMA

09 4LUPIN LTD

10 2MICRO LABS

11 2MYLAN

filter Dosage Reset all filters

26 All

01 8SUSPENSION;ORAL

02 18TABLET;ORAL

filter Regulatory Info Reset all filters

26 All

01 1DISCN

02 25RX

filter Brand Name Reset all filters

26 All

01 4BANZEL

02 22RUFINAMIDE

filter RLD Reset all filters

26 All

01 22No

02 4Yes

FDF Dossiers
FDA Orange Book
Europe
Canada

List of Suppliers

Product Main Page

01

EISAI INC

AAPS 2024

Not Confirmed

EISAI INC

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

Brand Name : BANZEL

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-11-14

Application Number : 21911

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

EISAI INC

AAPS 2024

Not Confirmed

EISAI INC

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : BANZEL

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2008-11-14

Application Number : 21911

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

EISAI INC

AAPS 2024

Not Confirmed

EISAI INC

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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RLD : Yes

TE Code : AB

Brand Name : BANZEL

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2008-11-14

Application Number : 21911

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

EISAI INC

AAPS 2024

Not Confirmed

EISAI INC

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : BANZEL

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 40MG/ML

Approval Date : 2011-03-03

Application Number : 201367

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

HETERO LABS LTD III

AAPS 2024

Not Confirmed

HETERO LABS LTD III

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code : AB

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2021-05-11

Application Number : 204993

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

HIKMA

AAPS 2024

Not Confirmed

HIKMA

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code : AB

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2016-05-16

Application Number : 204988

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

HIKMA

AAPS 2024

Not Confirmed

HIKMA

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

RLD : No

TE Code : AB

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2016-05-16

Application Number : 204988

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

LUPIN LTD

AAPS 2024

Not Confirmed

LUPIN LTD

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2022-08-17

Application Number : 204964

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

09

LUPIN LTD

AAPS 2024

Not Confirmed

LUPIN LTD

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

RLD : No

TE Code : AB

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2022-08-17

Application Number : 204964

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

10

LUPIN LTD

AAPS 2024

Not Confirmed

LUPIN LTD

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code : AB

Brand Name : RUFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2022-08-17

Application Number : 204964

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

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