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List of Drug Master Files (DMF) of Tox21_300112 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Tox21_300112
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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Tox21_300112

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 14 USDMF, 4 CEP/COS, 2 JDMF, 15 NDC API, 14 Listed Suppliers, $ API Reference Price

29 API Suppliers
14 USDMF
4 CEP/COS
2 JDMF
15 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

94 Drugs in Development

94 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

167 FDF Dossiers, 66 FDA Orange Book, 42 Europe, 6 Canada, 28 Australia, 11 South Africa, 14 Listed Dossiers

167 FDF Dossiers
66 FDA Orange Book
42 Europe
6 Canada
28 Australia
11 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;TOPICAL - 2%, SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%, CREAM;TOPICAL - 4%

SOLUTION;TOPICAL - 2%
SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 0.5%
CREAM;TOPICAL - 4%

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 9 DKSH, 1 Jai Radhe Sales, 1 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Actylis, 10 BASF, 1 BioSpectra, 1 Clariant, 2 Corel Pharma Chem, 2 Finar, 6 Gangwal Chemicals, 7 Kerry, 2 Lubrizol Life Science Health, 3 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pluviaendo, 4 Roquette, 9 Seppic, 1 Valens Pharmachem

1 SPI Pharma
9 DKSH
1 Jai Radhe Sales
1 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
1 Pfanstiehl
5 Actylis
10 BASF
1 BioSpectra
1 Clariant
2 Corel Pharma Chem
2 Finar
6 Gangwal Chemicals
7 Kerry
2 Lubrizol Life Science Health
3 Microlex e.U
2 Nanjing Bold Chemical
1 Pluviaendo
4 Roquette
9 Seppic
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

27 Topical, 22 Solubilizers, 15 Parenteral, 11 Film Formers & Plasticizers, 10 Emulsifying Agents, 9 Thickeners and Stabilizers, 9 Fillers, Diluents & Binders, 9 Coating Systems & Additives, 7 Surfactant & Foaming Agents, 7 Co-Processed Excipients, 5 Direct Compression, 4 Lubricants & Glidants, 3 Controlled & Modified Release, 2 Granulation, 2 Rheology Modifiers, 1 API Stability Enhancers

27 Topical
22 Solubilizers
15 Parenteral
11 Film Formers & Plasticizers
10 Emulsifying Agents
9 Thickeners and Stabilizers
9 Fillers, Diluents & Binders
9 Coating Systems & Additives
7 Surfactant & Foaming Agents
7 Co-Processed Excipients
5 Direct Compression
4 Lubricants & Glidants
3 Controlled & Modified Release
2 Granulation
2 Rheology Modifiers
1 API Stability Enhancers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 37 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
37 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices, 1 Annual Reports

2 US Medicaid Prescriptions
46 Finished Drug Prices
1 Annual Reports

MARKET PLACE

13 APIs, 15 FDF Dossiers

13 APIs
15 FDF Dossiers

REF. STANDARDS & IMPURITIES

6 EDQM, 5 USP, 6 Others

6 EDQM
5 USP
6 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 353 Xls

Filters

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14 All

01 1Actylis

02 2Amcol

03 1Dolder AG

04 1Nantong Jinghua Pharmaceutical

05 1Teva API

06 8Blank

filter Subject Reset all filters

14 All

01 15-FLUORO-URACIL,PRODUCT 4965

02 55-FLUOROURACIL

03 4FLUOROURACIL

04 1FLUOROURACIL IN MICROSPONGE® POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)

05 1FLUOROURACIL USP

06 1POLY-PORE® FLUOROURACIL POLYMER

07 1STERILE PROCESSING FACILITY IN NEW MEXICO

filter Country Reset all filters

14 All

01 1China

02 1Israel

03 1Switzerland

04 3U.S.A

05 8Blank

filter Status Reset all filters

14 All

01 5Active

02 9Inactive

filter GDUFA DMF Review Reset all filters

14 All

01 4Complete

02 10Blank

API Suppliers
USDMF
CEP/COS
JDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Pharma-waldhof Gmbh

USDMF

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Not Confirmed

01

Pharma-waldhof Gmbh

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Not Confirmed

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Digital Content

5-fluoro-uracil,product 4965

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4959

Submission : 1983-05-18

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Amcol Health And Beauty Solutions In...

USDMF

Formnext Forum

Not Confirmed

02

Amcol Health And Beauty Solutions In...

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Digital Content

Poly-pore® Fluorouracil Polymer

GDUFA

DMF Review : Complete

Rev. Date : 2017-07-07

Pay. Date : 2015-07-08

DMF Number : 29443

Submission : 2015-11-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Amcol Health And Beauty Solutions In...

USDMF

Formnext Forum

Not Confirmed

03

Amcol Health And Beauty Solutions In...

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Digital Content

Fluorouracil In Microsponge® Polymer (flurour...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12738

Submission : 1997-11-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Imcd Switzerland Ag

USDMF

Formnext Forum

Not Confirmed

04

Imcd Switzerland Ag

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Digital Content

Fluorouracil

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-16

Pay. Date : 2014-05-20

DMF Number : 21774

Submission : 2008-06-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Nantong Jinghua Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

05

Nantong Jinghua Pharmaceutical Co Lt...

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Digital Content

Fluorouracil Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-05-06

Pay. Date : 2020-04-29

DMF Number : 18478

Submission : 2005-06-28

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

06

Teva Pharmaceutical Industries Ltd

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Digital Content

5-fluorouracil

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-30

Pay. Date : 2012-11-08

DMF Number : 3062

Submission : 1977-11-09

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Heinrich Mack Nachf

Country

USDMF

Formnext Forum

Not Confirmed

07

Heinrich Mack Nachf

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

5-fluorouracil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2892

Submission : 1977-03-08

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Internatl Chem & Nuclear Pharms Inc

Country

USDMF

Formnext Forum

Not Confirmed

08

Internatl Chem & Nuclear Pharms Inc

Country

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Not Confirmed

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Country

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Digital Content

5-fluorouracil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1138

Submission : 1968-02-02

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Teikoku Chem Industry

Country

USDMF

Formnext Forum

Not Confirmed

09

Teikoku Chem Industry

Country

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Fluorouracil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7179

Submission : 1987-10-08

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Andard Mount International Ltd

Country

USDMF

Formnext Forum

Not Confirmed

10

Andard Mount International Ltd

Country

Formnext Forum

Not Confirmed

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Country

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Fluorouracil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6098

Submission : 1985-10-23

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

1
2

Tox21_300112 Manufacturers | Traders | Suppliers

Tox21_300112 Manufacturers, Traders, Suppliers 1

48

We have 5 companies offering Tox21_300112

Get in contact with the supplier of your choice:

Actylis
Amcol
Dolder AG
Nantong Jinghua Pharmaceutical
Teva API

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