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Fampridine
FDA Orange Book

munit-sa-m-2025-04-14

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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

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

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Suanfarma, at the Core of a Better Life.

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xyz-pharma-m-2025-04-14

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Fampridine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 11 USDMF, 2 EU WC, 13 NDC API, 10 Listed Suppliers, $ API Reference Price

23 API Suppliers
11 USDMF
2 EU WC
13 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 10 FDA Orange Book, 8 Europe, 3 Canada, 1 South Africa, 9 Listed Dossiers

31 FDF Dossiers
10 FDA Orange Book
8 Europe
3 Canada
1 South Africa
9 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 1 Faran Shimi Pharmaceutical, 2 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

1 SPI Pharma
5 DKSH
1 Faran Shimi Pharmaceutical
2 Gangwal Healthcare
1 ACG Worldwide
3 Actylis
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
8 BASF
10 Corel Pharma Chem
2 DFE Pharma
1 Finar
6 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
15 Kerry
3 Kima Chemical
6 Lonza Capsugel
8 Microlex e.U
2 Nomisma Healthcare
1 Novo Excipients
1 Pharmatrans-Sanaq
1 Pluviaendo
2 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
9 Roquette
6 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
8 Sigachi Industries
2 The Dow Chemical Company
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 23 Controlled & Modified Release, 21 Fillers, Diluents & Binders, 17 Thickeners and Stabilizers, 10 Lubricants & Glidants, 9 Direct Compression, 8 Granulation, 7 Film Formers & Plasticizers, 7 Topical, 5 Co-Processed Excipients, 5 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 Solubilizers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Rheology Modifiers, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids

43 Coating Systems & Additives
23 Controlled & Modified Release
21 Fillers, Diluents & Binders
17 Thickeners and Stabilizers
10 Lubricants & Glidants
9 Direct Compression
8 Granulation
7 Film Formers & Plasticizers
7 Topical
5 Co-Processed Excipients
5 Disintegrants & Superdisintegrants
5 Empty Capsules
5 Solubilizers
4 Vegetarian Capsules
4 API Stability Enhancers
4 Taste Masking
4 Coloring Agents
4 Rheology Modifiers
4 Emulsifying Agents
3 Chewable & Orodispersible Aids

DIGITAL CONTENT

39 News #PharmaBuzz

39 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 7 Regulatory FDF Prices, 9 Annual Reports

1 US Medicaid Prescriptions
7 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

1 Health Canada Patents

1 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 5 Others

5 USP
5 Others

$ API Ref.Price (USD/KG) : 5,496 Xls

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10 All

01 1ACCORD HLTHCARE

02 1ACTAVIS LABS FL INC

03 1ALKEM LABS LTD

04 1AUROBINDO PHARMA

05 1HIKMA

06 1MERZ

07 1MICRO LABS

08 1RISING

09 1SUN PHARM

10 1TEVA PHARMS USA INC

filter Dosage Reset all filters

10 All

01 10TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

10 All

01 2DISCN

02 7RX

03 1Blank

filter Brand Name Reset all filters

10 All

01 1AMPYRA

02 9DALFAMPRIDINE

filter RLD Reset all filters

10 All

01 8No

02 1Yes

03 1Blank

List of Suppliers

Product Main Page

01

ACCORD HLTHCARE

German Wound Congress

Not Confirmed

ACCORD HLTHCARE

German Wound Congress

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-07-11

Application Number : 206863

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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02

ACTAVIS LABS FL INC

German Wound Congress

Not Confirmed

ACTAVIS LABS FL INC

German Wound Congress

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2017-01-23

Application Number : 206836

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Digital Content

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03

ALKEM LABS LTD

German Wound Congress

Not Confirmed

ALKEM LABS LTD

German Wound Congress

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-07-30

Application Number : 206765

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

04

AUROBINDO PHARMA

German Wound Congress

Not Confirmed

AUROBINDO PHARMA

German Wound Congress

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2017-01-23

Application Number : 206811

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

05

HIKMA

German Wound Congress

Not Confirmed

HIKMA

German Wound Congress

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Digital Content

RLD : No

TE Code :

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-10-24

Application Number : 206646

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

MICRO LABS

German Wound Congress

Not Confirmed

MICRO LABS

German Wound Congress

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2019-03-11

Application Number : 210158

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

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07

RISING

German Wound Congress

Not Confirmed

RISING

German Wound Congress

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Digital Content

RLD : No

TE Code :

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2020-07-06

Application Number : 206858

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SUN PHARM

German Wound Congress

Not Confirmed

SUN PHARM

German Wound Congress

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2019-05-21

Application Number : 208292

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

TEVA PHARMS USA INC

German Wound Congress

Not Confirmed

TEVA PHARMS USA INC

German Wound Congress

Not Confirmed

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Digital Content

RLD :

TE Code :

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 206854

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

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10

MERZ

Country

German Wound Congress

Not Confirmed

MERZ

Country

German Wound Congress

Not Confirmed

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Country

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Digital Content

RLD : Yes

TE Code : AB

DALFAMPRIDINE

Brand Name : AMPYRA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2010-01-22

Application Number : 22250

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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