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Dimethyl Fumarate
FDA Orange Book

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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Dimethyl Fumarate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 29 USDMF, 16 EU WC, 6 KDMF, 24 NDC API, 36 Listed Suppliers, $ API Reference Price

51 API Suppliers
29 USDMF
16 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

106 FDF Dossiers, 38 FDA Orange Book, 12 Europe, 18 Canada, 16 Australia, 2 South Africa, 20 Listed Dossiers

106 FDF Dossiers
38 FDA Orange Book
12 Europe
18 Canada
16 Australia
2 South Africa
20 Listed Dossiers

RELATED EXCIPIENT COMPANIES

5 Evonik, 2 SPI Pharma, 9 DKSH, 3 Faran Shimi Pharmaceutical, 3 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

30 Coating Systems & Additives, 24 Fillers, Diluents & Binders, 17 Controlled & Modified Release, 17 Thickeners and Stabilizers, 16 Solubilizers, 14 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 12 Direct Compression, 10 Granulation, 9 Film Formers & Plasticizers, 8 Empty Capsules, 8 Taste Masking, 6 Emulsifying Agents, 6 Co-Processed Excipients, 5 Parenteral, 4 Surfactant & Foaming Agents, 4 Topical, 4 Rheology Modifiers, 3 Coloring Agents, 2 API Stability Enhancers, 2 Chewable & Orodispersible Aids

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 150 News #PharmaBuzz

1 Data Compilation #PharmaFlow
150 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Regulatory FDF Prices, 12 Annual Reports

2 US Medicaid Prescriptions
10 Regulatory FDF 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) : 336 Xls

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38 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 2TORRENT

18 2TWI PHARMS

19 2ZYDUS PHARMS

filter Dosage Reset all filters

38 All

01 38CAPSULE, DELAYED RELEASE;ORAL

filter Regulatory Info Reset all filters

38 All

01 4DISCN

02 32RX

03 2Blank

filter Brand Name Reset all filters

38 All

01 36DIMETHYL FUMARATE

02 2TECFIDERA

filter RLD Reset all filters

38 All

01 34No

02 2Yes

03 2Blank

List of Suppliers

Product Main Page

01

BIOGEN INC

ASPEN

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BIOGEN INC

ASPEN

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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

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02

BIOGEN INC

ASPEN

Not Confirmed

BIOGEN INC

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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

ASPEN

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CIPLA

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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 : 2020-09-24

Application Number : 210305

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

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04

CIPLA

ASPEN

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CIPLA

ASPEN

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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 : 2020-09-24

Application Number : 210305

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

LUPIN

ASPEN

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LUPIN

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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 : 2020-10-05

Application Number : 210226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Digital Content

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06

LUPIN

ASPEN

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LUPIN

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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

ASPEN

Not Confirmed

SAWAI USA

ASPEN

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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 :

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08

SAWAI USA

ASPEN

Not Confirmed

SAWAI USA

ASPEN

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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

ASPEN

Not Confirmed

SHILPA MEDICARE LTD

ASPEN

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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 :

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Digital Content

10

SHILPA MEDICARE LTD

ASPEN

Not Confirmed

SHILPA MEDICARE LTD

ASPEN

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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