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List of Drug Master Files (DMF) of NCGC00024890-06 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

NCGC00024890-06
USDMF

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

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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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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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NCGC00024890-06

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
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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12 All

01 1Seqens

02 1Alkem Laboratories

03 1Aurobindo Pharma Limited

04 1Enaltec Labs Private Limited

05 1Industriale Chimica

06 1Intas Pharmaceuticals

07 1Jubilant Generics

08 1Micro Labs Limited

09 1Procos

10 1Regis Technologies

11 1SIGMA TAU

12 1Sun Pharmaceutical Industries Limited

filter Subject Reset all filters

12 All

01 14-AMINOPYRIDINE

02 6DALFAMPRIDINE

03 4DALFAMPRIDINE USP

04 1STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN ROCKAWAY, NJ

filter Country Reset all filters

12 All

01 1France

02 7India

03 2Italy

04 2U.S.A

filter Status Reset all filters

12 All

01 10Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

12 All

01 8Complete

02 4Blank

API Suppliers
USDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Cu Chemie Uetikon Gmbh

CPhI Worldwide, Milan

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

Contact Supplier

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Digital Content

Dalfampridine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17860

Submission : 2004-11-29

Status : Active

Type : II

Seqens Company Banner

Product Web Link

Digital Content

02

Alkem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

02

Alkem Laboratories Ltd

Formnext Forum

Not Confirmed

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Digital Content

Dalfampridine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-24

Pay. Date : 2013-11-19

DMF Number : 27637

Submission : 2013-11-01

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

03

Apitoria Pharma Private Ltd

USDMF

Formnext Forum

Not Confirmed

03

Apitoria Pharma Private Ltd

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Digital Content

Dalfampridine

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-26

Pay. Date : 2014-01-06

DMF Number : 27843

Submission : 2014-01-09

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Industriale Chimica Srl

USDMF

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Not Confirmed

04

Industriale Chimica Srl

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Digital Content

Dalfampridine

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-03

Pay. Date : 2013-11-12

DMF Number : 27623

Submission : 2013-10-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Intas Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

05

Intas Pharmaceuticals Ltd

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Digital Content

Dalfampridine

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-24

Pay. Date : 2013-12-27

DMF Number : 27819

Submission : 2013-12-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Jubilant Pharmova Ltd

USDMF

Formnext Forum

Not Confirmed

06

Jubilant Pharmova Ltd

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Digital Content

Dalfampridine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-04

Pay. Date : 2013-12-20

DMF Number : 24718

Submission : 2011-03-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Micro Labs Ltd

USDMF

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Not Confirmed

07

Micro Labs Ltd

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Digital Content

Dalfampridine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2018-12-10

Pay. Date : 2018-09-28

DMF Number : 33146

Submission : 2018-09-27

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Procos Spa

USDMF

Formnext Forum

Not Confirmed

08

Procos Spa

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Not Confirmed

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Digital Content

Dalfampridine

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-26

Pay. Date : 2013-11-20

DMF Number : 27647

Submission : 2013-10-15

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Regis Technologies Inc

USDMF

Formnext Forum

Not Confirmed

09

Regis Technologies Inc

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Digital Content

4-aminopyridine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4827

Submission : 1983-03-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Sun Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

10

Sun Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Dalfampridine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-05

Pay. Date : 2013-11-01

DMF Number : 27662

Submission : 2013-11-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

NCGC00024890-06 Manufacturers | Traders | Suppliers

NCGC00024890-06 Manufacturers, Traders, Suppliers 1

86

We have 12 companies offering NCGC00024890-06

Get in contact with the supplier of your choice:

Seqens
Alkem Laboratories
Aurobindo Pharma Limited
Enaltec Labs Private Limited
Industriale Chimica
Intas Pharmaceuticals
Jubilant Generics
Micro Labs Limited
Procos
Regis Technologies
SIGMA TAU
Sun Pharmaceutical Industries Limited

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