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List of Drug Master Files (DMF) of Tox21_300265 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Tox21_300265
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_300265

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 21 USDMF, 16 CEP/COS, 13 JDMF, 7 EU WC, 20 KDMF, 27 NDC API, 43 Listed Suppliers, $ API Reference Price

73 API Suppliers
21 USDMF
16 CEP/COS
13 JDMF
7 EU WC
20 KDMF
27 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 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

FINISHED DOSAGE FORMULATIONS

459 FDF Dossiers, 99 FDA Orange Book, 100 Europe, 37 Canada, 62 South Africa, 161 Listed Dossiers

459 FDF Dossiers
99 FDA Orange Book
100 Europe
37 Canada
62 South Africa
161 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2%, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;TOPICAL - 2%
TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TOPICAL - 1%
SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 11 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 12 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 48 BASF, 1 BioSpectra, 18 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 14 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 15 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 72 Coating Systems & Additives, 50 Direct Compression, 50 Controlled & Modified Release, 47 Solubilizers, 41 Disintegrants & Superdisintegrants, 39 Topical, 38 Thickeners and Stabilizers, 35 Granulation, 29 Parenteral, 25 Lubricants & Glidants, 24 Film Formers & Plasticizers, 23 Co-Processed Excipients, 20 Taste Masking, 19 Emulsifying Agents, 10 Chewable & Orodispersible Aids, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules

86 Fillers, Diluents & Binders
72 Coating Systems & Additives
50 Direct Compression
50 Controlled & Modified Release
47 Solubilizers
41 Disintegrants & Superdisintegrants
39 Topical
38 Thickeners and Stabilizers
35 Granulation
29 Parenteral
25 Lubricants & Glidants
24 Film Formers & Plasticizers
23 Co-Processed Excipients
20 Taste Masking
19 Emulsifying Agents
10 Chewable & Orodispersible Aids
9 API Stability Enhancers
8 Surfactant & Foaming Agents
5 Coloring Agents
5 Empty Capsules
4 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

96 Finished Drug Prices, 5 Annual Reports

96 Finished Drug Prices
5 Annual Reports

MARKET PLACE

60 APIs, 23 FDF Dossiers

60 APIs
23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 Health Canada Patents

26 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

2 EDQM
1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 25 Xls

Filters

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21 All

01 2Amoli Organics

02 1Assia Chemical Industries Ltd

03 1Cheng Fong Chemical Co., Ltd

04 1Corden Pharma Bergamo S.p.A

05 1Dipharma

06 2Esteve Quimica

07 1Hainan Poly Pharm

08 1Henan Dongtai Pharma Co Ltd.

09 1Heumann

10 1Hisamitsu Pharmaceutical Co., Inc.

11 1J.B.Chemicals & Pharmaceuticals

12 1Laboratorio Chimico Internazionale Spa

13 1Macleods Pharmaceuticals Limited

14 1Ningbo Smart Pharmaceutical

15 1Syn-Tech Chem. & Pharm

16 1Teva Pharmaceutical Industries

17 2YUNG ZIP CHEMICAL INDUSTRIAL

18 1Yonezawa Hamari Chemicals\

filter Subject Reset all filters

21 All

01 12DICLOFENAC SODIUM

02 1DICLOFENAC SODIUM (PROCESS II)

03 1DICLOFENAC SODIUM EP/USP

04 1DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES

05 1DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE

06 4DICLOFENAC SODIUM USP

07 1HP-5000, TOPICAL PATCH

filter Country Reset all filters

21 All

01 4China

02 1Germany

03 4India

04 2Israel

05 3Italy

06 2Japan

07 2Spain

08 3Taiwan

filter Status Reset all filters

21 All

01 12Active

02 9Inactive

filter GDUFA DMF Review Reset all filters

21 All

01 10Complete

02 11Blank

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Amoli Organics Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

01

Amoli Organics Pvt Ltd

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Digital Content

Diclofenac Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-23

Pay. Date : 2013-07-10

DMF Number : 20849

Submission : 2007-09-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Cheng Fong Chemical Co Ltd

USDMF

Formnext Forum

Not Confirmed

02

Cheng Fong Chemical Co Ltd

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Digital Content

Diclofenac Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-19

Pay. Date : 2013-06-10

DMF Number : 8192

Submission : 1989-08-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Dipharma Francis Srl

USDMF

Formnext Forum

Not Confirmed

03

Dipharma Francis Srl

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Digital Content

Diclofenac Sodium Ep/usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-28

Pay. Date : 2013-09-24

DMF Number : 6689

Submission : 1986-11-20

Status : Active

Type : II

Product Web Link

Digital Content

04

Henan Dongtai Pharm Co Ltd

USDMF

Formnext Forum

Not Confirmed

04

Henan Dongtai Pharm Co Ltd

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Digital Content

Diclofenac Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2021-09-01

Pay. Date : 2021-06-01

DMF Number : 24580

Submission : 2011-01-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Hisamitsu Pharmaceutical Co Inc

USDMF

Formnext Forum

Not Confirmed

05

Hisamitsu Pharmaceutical Co Inc

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Digital Content

Hp-5000, Topical Patch

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 30798

Submission : 2016-11-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Unique Chemicals

USDMF

Formnext Forum

Not Confirmed

06

Unique Chemicals

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Digital Content

Diclofenac Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-18

Pay. Date : 2012-12-14

DMF Number : 12469

Submission : 1997-04-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Olon Spa

USDMF

Formnext Forum

Not Confirmed

07

Olon Spa

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Digital Content

Diclofenac Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-13

Pay. Date : 2014-06-06

DMF Number : 8924

Submission : 1991-01-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Ningbo Smart Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

08

Ningbo Smart Pharmaceutical Co Ltd

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Digital Content

Diclofenac Sodium

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18877

Submission : 2005-10-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Syn-tech Chem And Pharm Co Ltd

USDMF

Formnext Forum

Not Confirmed

09

Syn-tech Chem And Pharm Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Diclofenac Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-10

Pay. Date : 2013-03-27

DMF Number : 9899

Submission : 1992-10-05

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Yung Zip Chemical Ind Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Yung Zip Chemical Ind Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Diclofenac Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-28

Pay. Date : 2013-01-11

DMF Number : 6981

Submission : 1987-05-27

Status : Active

Type : II

Product Web Link

Digital Content

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Tox21_300265 Manufacturers | Traders | Suppliers

Tox21_300265 Manufacturers, Traders, Suppliers 1

18

We have 18 companies offering Tox21_300265

Get in contact with the supplier of your choice:

Amoli Organics
Assia Chemical Industries Ltd
Cheng Fong Chemical Co., Ltd
Corden Pharma Bergamo S.p.A
Dipharma
Esteve Quimica
Hainan Poly Pharm
Henan Dongtai Pharma Co Ltd.
Heumann
Hisamitsu Pharmaceutical Co., Inc.
J.B.Chemicals & Pharmaceuticals
Laboratorio Chimico Internazionale Spa
Macleods Pharmaceuticals Limited
Ningbo Smart Pharmaceutical
Syn-Tech Chem. & Pharm
Teva Pharmaceutical Industries
Yonezawa Hamari Chemicals\
YUNG ZIP CHEMICAL INDUSTRIAL

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