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List of Drug Master Files (DMF) of Rufinamide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Rufinamide
USDMF

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
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

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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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9 All

01 1Apotex Pharmachem

02 1Dipharma

03 1Glenmark Life Sciences

04 1Hetero Drugs

05 1Lupin Ltd

06 2MSN Laboratories

07 1Micro Labs Limited

08 1Zhejiang Jiuzhou Pharmaceutical

filter Subject Reset all filters

9 All

01 3RUFINAMIDE

02 5RUFINAMIDE USP

03 1RUFINAMIDE USP [ROUTE CODE "RU"]

filter Country Reset all filters

9 All

01 1Canada

02 1China

03 6India

04 1Italy

filter Status Reset all filters

9 All

01 8Active

02 1Inactive

filter GDUFA DMF Review Reset all filters

9 All

01 8Complete

02 1Blank

API Suppliers
USDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Apotex Pharmachem Inc

USDMF

AAPS 2024

Not Confirmed

01

Apotex Pharmachem Inc

AAPS 2024

Not Confirmed

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Digital Content

Rufinamide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-07-21

Pay. Date : 2015-03-16

DMF Number : 29034

Submission : 2015-03-27

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

02

Dipharma Francis Srl

USDMF

AAPS 2024

Not Confirmed

02

Dipharma Francis Srl

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

Rufinamide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-07

Pay. Date : 2012-11-09

DMF Number : 25676

Submission : 2012-01-04

Status : Active

Type : II

Product Web Link

Digital Content

03

Glenmark Life Sciences Ltd

USDMF

AAPS 2024

Not Confirmed

03

Glenmark Life Sciences Ltd

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-24

Pay. Date : 2012-11-06

DMF Number : 26209

Submission : 2012-10-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Hetero Drugs Ltd

USDMF

AAPS 2024

Not Confirmed

04

Hetero Drugs Ltd

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2021-10-07

Pay. Date : 2021-07-13

DMF Number : 36077

Submission : 2021-08-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Lupin Manufacturing Solutions Ltd

USDMF

AAPS 2024

Not Confirmed

05

Lupin Manufacturing Solutions Ltd

AAPS 2024

Not Confirmed

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Digital Content

Rufinamide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-23

Pay. Date : 2012-11-13

DMF Number : 26316

Submission : 2012-10-09

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Micro Labs Ltd

USDMF

AAPS 2024

Not Confirmed

06

Micro Labs Ltd

AAPS 2024

Not Confirmed

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Digital Content

Rufinamide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-05-03

Pay. Date : 2023-04-12

DMF Number : 38182

Submission : 2023-03-23

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Msn Life Sciences Private Ltd

USDMF

AAPS 2024

Not Confirmed

07

Msn Life Sciences Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Rufinamide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2018-09-10

Pay. Date : 2018-07-16

DMF Number : 32713

Submission : 2018-04-30

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Msn Laboratories Private Ltd

USDMF

AAPS 2024

Not Confirmed

08

Msn Laboratories Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Rufinamide Usp [route Code "ru"]

GDUFA

DMF Review : Complete

Rev. Date : 2019-01-03

Pay. Date : 2018-07-26

DMF Number : 26385

Submission : 2012-09-29

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Zhejiang Jiuzhou Pharmaceutical Co L...

USDMF

AAPS 2024

Not Confirmed

09

Zhejiang Jiuzhou Pharmaceutical Co L...

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28284

Submission : 2014-05-09

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Rufinamide Manufacturers | Traders | Suppliers

Rufinamide Manufacturers, Traders, Suppliers 1

77

We have 8 companies offering Rufinamide

Get in contact with the supplier of your choice:

Apotex Pharmachem
Dipharma
Glenmark Life Sciences
Hetero Drugs
Lupin Ltd
Micro Labs Limited
MSN Laboratories
Zhejiang Jiuzhou Pharmaceutical

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