Dimethyl Fumarate | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Dimethyl Fumarate
FDA Orange Book

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Dimethyl Fumarate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 29 USDMF, 15 EU WC, 6 KDMF, 24 NDC API, 36 Listed Suppliers, $ API Reference Price

52 API Suppliers
29 USDMF
15 EU WC
6 KDMF
24 NDC API
36 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

103 FDF Dossiers, 36 FDA Orange Book, 12 Europe, 18 Canada, 16 Australia, 2 South Africa, 19 Listed Dossiers

103 FDF Dossiers
36 FDA Orange Book
12 Europe
18 Canada
16 Australia
2 South Africa
19 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 SPI Pharma, 8 DKSH, 2 Jai Radhe Sales, 3 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 4 Corel Pharma Chem, 3 DFE Pharma, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 3 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

28 Coating Systems & Additives, 27 Fillers, Diluents & Binders, 18 Controlled & Modified Release, 17 Thickeners and Stabilizers, 17 Direct Compression, 15 Lubricants & Glidants, 14 Disintegrants & Superdisintegrants, 14 Solubilizers, 10 Granulation, 9 Co-Processed Excipients, 8 Film Formers & Plasticizers, 8 Empty Capsules, 8 Taste Masking, 6 Emulsifying Agents, 5 Parenteral, 4 Topical, 4 Surfactant & Foaming Agents, 3 Coloring Agents, 3 Rheology Modifiers, 2 Chewable & Orodispersible Aids, 2 API Stability Enhancers

28 Coating Systems & Additives
27 Fillers, Diluents & Binders
18 Controlled & Modified Release
17 Thickeners and Stabilizers
17 Direct Compression
15 Lubricants & Glidants
14 Disintegrants & Superdisintegrants
14 Solubilizers
10 Granulation
9 Co-Processed Excipients
8 Film Formers & Plasticizers
8 Empty Capsules
8 Taste Masking
6 Emulsifying Agents
5 Parenteral
4 Topical
4 Surfactant & Foaming Agents
3 Coloring Agents
3 Rheology Modifiers
2 Chewable & Orodispersible Aids
2 API Stability Enhancers

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 149 NEWS #PharmaBuzz

7 DATA COMPILATION #PharmaFlow
149 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Finished Drug Prices, 12 Annual Reports

2 US Medicaid Prescriptions
10 Finished Drug Prices
12 Annual Reports

MARKET PLACE

2 APIs, 6 FDF Dossiers, 1 Intermediates

2 APIs
6 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

18 US Patents, 1 Health Canada Patents

18 US Patents
1 Health Canada Patents

$ API Ref.Price (USD/KG) : 262 Xls

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36 All

01 2ACCORD HLTHCARE

02 2ALKEM LABS LTD

03 2AMNEAL

04 2AUROBINDO PHARMA

05 2BIOGEN INC

06 2CIPLA

07 2GLENMARK PHARMS LTD

08 2HETERO LABS LTD III

09 2LUPIN

10 2MACLEODS PHARMS LTD

11 2MSN

12 2MYLAN

13 2PRINSTON INC

14 2SAWAI USA

15 2SHILPA MEDICARE LTD

16 2SOLA PHARMS

17 2TWI PHARMS

18 2ZYDUS PHARMS

filter Dosage Reset all filters

36 All

01 36CAPSULE, DELAYED RELEASE;ORAL

filter Regulatory Info Reset all filters

36 All

01 4DISCN

02 30RX

03 2Blank

filter Brand Name Reset all filters

36 All

01 34DIMETHYL FUMARATE

02 2TECFIDERA

filter RLD Reset all filters

36 All

01 32No

02 2Yes

03 2Blank

List of Suppliers

Product Main Page

01

BIOGEN INC

CPhI India 2024

Not Confirmed

BIOGEN INC

CPhI India 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

DIMETHYL FUMARATE

Brand Name : TECFIDERA

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 2013-03-27

Application Number : 204063

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

BIOGEN INC

CPhI India 2024

Not Confirmed

BIOGEN INC

CPhI India 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

DIMETHYL FUMARATE

Brand Name : TECFIDERA

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 240MG

Approval Date : 2013-03-27

Application Number : 204063

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

CIPLA

CPhI India 2024

Not Confirmed

CIPLA

CPhI India 2024

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 2020-09-24

Application Number : 210305

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

CIPLA

CPhI India 2024

Not Confirmed

CIPLA

CPhI India 2024

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 240MG

Approval Date : 2020-09-24

Application Number : 210305

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

LUPIN

CPhI India 2024

Not Confirmed

LUPIN

CPhI India 2024

Not Confirmed

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RLD : No

TE Code : AB

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 2020-10-05

Application Number : 210226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

06

LUPIN

CPhI India 2024

Not Confirmed

LUPIN

CPhI India 2024

Not Confirmed

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RLD : No

TE Code : AB

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 240MG

Approval Date : 2020-10-05

Application Number : 210226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

07

SAWAI USA

CPhI India 2024

Not Confirmed

SAWAI USA

CPhI India 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 2021-12-21

Application Number : 210285

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

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08

SAWAI USA

CPhI India 2024

Not Confirmed

SAWAI USA

CPhI India 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 240MG

Approval Date : 2021-12-21

Application Number : 210285

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

SHILPA MEDICARE LTD

CPhI India 2024

Not Confirmed

SHILPA MEDICARE LTD

CPhI India 2024

Not Confirmed

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RLD :

TE Code :

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date :

Application Number : 210291

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

10

SHILPA MEDICARE LTD

CPhI India 2024

Not Confirmed

SHILPA MEDICARE LTD

CPhI India 2024

Not Confirmed

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Digital Content

RLD :

TE Code :

DIMETHYL FUMARATE

Brand Name : DIMETHYL FUMARATE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 240MG

Approval Date :

Application Number : 210291

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

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