Banzel, Rufinamide | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Banzel, Rufinamide
FDA Orange Book

Veranova: A CDMO that manages complexity with confidence.

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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

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pharmacompass-2-m-2025-08-25

Banzel, Rufinamide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 9 USDMF, 3 EU WC, 8 NDC API, 8 Listed Suppliers, $ API Reference Price

18 API Suppliers
9 USDMF
3 EU WC
8 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 27 FDA Orange Book, 15 Europe, 5 Canada

47 FDF Dossiers
27 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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 11 DKSH, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 15 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 2 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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, 9 Sigachi Industries, 2 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 31 Thickeners and Stabilizers, 21 Direct Compression, 20 Controlled & Modified Release, 19 Granulation, 17 Film Formers & Plasticizers, 16 Topical, 14 Lubricants & Glidants, 13 Taste Masking, 12 Rheology Modifiers, 11 Co-Processed Excipients, 11 Solubilizers, 9 Disintegrants & Superdisintegrants, 9 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 5 Parenteral, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

22 News #PharmaBuzz

22 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 14 Annual Reports

9 US Medicaid Prescriptions
15 Regulatory FDF Prices
14 Annual Reports

MARKET PLACE

1 APIs

1 APIs

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,555 Xls

Filters

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27 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 1MSN

12 2NORVIUM BIOSCIENCE

filter Dosage Reset all filters

27 All

01 9SUSPENSION;ORAL

02 18TABLET;ORAL

filter Regulatory Info Reset all filters

27 All

01 1DISCN

02 26RX

filter Brand Name Reset all filters

27 All

01 4BANZEL

02 23RUFINAMIDE

filter RLD Reset all filters

27 All

01 23No

02 4Yes

List of Suppliers

Product Main Page

01

EISAI INC

EPSC

Not Confirmed

EISAI INC

EPSC

Not Confirmed

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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

EPSC

Not Confirmed

EISAI INC

EPSC

Not Confirmed

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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

EPSC

Not Confirmed

EISAI INC

EPSC

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 : 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

EPSC

Not Confirmed

EISAI INC

EPSC

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

EPSC

Not Confirmed

HETERO LABS LTD III

EPSC

Not Confirmed

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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

EPSC

Not Confirmed

HIKMA

EPSC

Not Confirmed

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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

EPSC

Not Confirmed

HIKMA

EPSC

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 : 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

EPSC

Not Confirmed

LUPIN LTD

EPSC

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

LUPIN LTD

EPSC

Not Confirmed

LUPIN LTD

EPSC

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 : 200MG

Approval Date : 2022-08-17

Application Number : 204964

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

LUPIN LTD

EPSC

Not Confirmed

LUPIN LTD

EPSC

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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