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Approved Drug Products containing NCGC00024890-10 listed in the FDA Orange Book. Original Data : FDA Website

Client Email

Product

NCGC00024890-10
FDA Orange Book

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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FAMAR CDMO- From early development to commercial manufacturing.

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xyz-pharma-m-2024-09-09

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Veranova: A CDMO that manages complexity with confidence.

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xyz-pharma-m-2024-09-09

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NCGC00024890-10

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 12 USDMF, 1 EU WC, 14 NDC API, 10 Listed Suppliers, $ API Reference Price

16 API Suppliers
12 USDMF
1 EU WC
14 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

FINISHED DOSAGE FORMULATIONS

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

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

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 3 DKSH, 6 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
2 Seqens
3 DKSH
6 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, 24 Controlled & Modified Release, 23 Fillers, Diluents & Binders, 16 Thickeners and Stabilizers, 14 Direct Compression, 11 Lubricants & Glidants, 8 Co-Processed Excipients, 8 Granulation, 7 Film Formers & Plasticizers, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 Solubilizers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 2 Parenteral, 2 Rheology Modifiers

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 39 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
39 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 7 Finished Drug Prices, 9 Annual Reports

1 US Medicaid Prescriptions
7 Finished Drug 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) : 5,607 Xls

Filters

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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 PHARMS GMBH

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

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

ACCORD HLTHCARE

BioProcess International

Not Confirmed

ACCORD HLTHCARE

BioProcess International

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

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

Product Web Link

Digital Content

Corporate PDF

02

ACTAVIS LABS FL INC

BioProcess International

Not Confirmed

ACTAVIS LABS FL INC

BioProcess International

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

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

Product Web Link

Digital Content

Corporate PDF

03

ALKEM LABS LTD

BioProcess International

Not Confirmed

ALKEM LABS LTD

BioProcess International

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

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

BioProcess International

Not Confirmed

AUROBINDO PHARMA

BioProcess International

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

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

BioProcess International

Not Confirmed

HIKMA

BioProcess International

Not Confirmed

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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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

MICRO LABS

BioProcess International

Not Confirmed

MICRO LABS

BioProcess International

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

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

Product Web Link

Digital Content

Corporate PDF

07

RISING

BioProcess International

Not Confirmed

RISING

BioProcess International

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 :

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

BioProcess International

Not Confirmed

SUN PHARM

BioProcess International

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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Post an Enquiry

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

BioProcess International

Not Confirmed

TEVA PHARMS USA INC

BioProcess International

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 :

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

Product Web Link

Digital Content

Corporate PDF

10

MERZ PHARMS GMBH

Country

BioProcess International

Not Confirmed

MERZ PHARMS GMBH

Country

BioProcess International

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

Country

Virtual Booth

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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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