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Approved Marketing Authorisations (MA) containing Tox21_300265 in Europe. Original Data : EMA Website

Client Email

Product

Tox21_300265
Europe

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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Tox21_300265

ACCESS ALL DATA, CHEMISTRY

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TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2%, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

FILTER :

filter Applicant Reset all filters

100 All

01 2Almirall AG

02 1Almirall SA

03 1BIOINDUSTRIA FARMACEUTICI Srl

04 2Bluefish Pharmaceuticals AB

05 2Dermapharm AG

06 1Deva Holding AS

07 7Dr. Grossmann AG Pharmaca

08 2Farmak JSC

09 2Gebro Pharma AG

10 1Haleon Schweiz AG

11 1IBSA Institut Biochimique SA

12 1Laboratoires Théa

13 1Meda OTC AB

14 14Mepha Pharma AG

15 4Mylan AB

16 17Novartis Pharma Schweiz AG

17 2Orifarm Generics A / S

18 1PFIZER ITALIA Srl

19 2Pfizer

20 6Pfizer AG

21 1Sandoz GmbH

22 11Sandoz Pharmaceuticals AG

23 8Spirig HealthCare AG

24 2Streuli Pharma AG

25 1Thea PHARMA SA

26 7World Medicine Ilac San ve tic LTD STl

filter Active Ingredients Reset all filters

100 All

01 9Diclofenac Sodium

02 2Diclofenac Sodium; Misoprostol

03 1Diclofenac Sodium; Thiamine; Pyridoxine; Cobamet

04 68Diclofenac sodium

05 6Diclofenacum natricum; Misoprostolum

06 2Several substances refer to content

07 12diclofenac sodium

filter Dosage Form Reset all filters

100 All

01 6Bitabs

02 1CAPSULE

03 1CUTANEOUS SPRAY, GEL

04 4Caps

05 1Capsules

06 3Depocaps

07 2Depotabs

08 4Drag

09 1Drops

10 1EYE DROPS

11 1EYE DROPS, SOLUTION

12 3Emulgel

13 2Emuls

14 1Eye Drop

15 6Filmtabl

16 7GASTRO

17 3GEL

18 12Gel

19 1Gtt Opht

20 1INJECTABLE

21 1Inj Inf Prep

22 1Inj L?s

23 2Kaps

24 4Lactabs

25 2Lipogel

26 2MODIFIED-RELEASE TABLET

27 1RETARD TABLET

28 5Ret Drag

29 4Ret Filmtabl

30 3SUPPOSITORY

31 6Supp

32 3Tabl

33 2Tablet

34 1Unit Dose Eye Drops

35 2Blank

filter Country Reset all filters

100 All

01 2Italy

02 14Sweden

03 74Switzerland

04 8Turkey

05 2Ukraine

filter Brand Name Reset all filters

100 All

01 2Arthrotec

02 3Arthrotec 50

03 3Arthrotec 75

04 1Artrotec

05 1Dicloabac

06 1Dicloabak

07 2Diclofenac Bluefish

08 4Diclofenac Mylan

09 2Diclofenac Orifarm

10 1Diclofenac Sandoz

11 1Diclofenac sodium

12 1Diphtale

13 4Ecofenac

14 5Ecofenac CR

15 2Ecofenac Sandoz

16 1Eeze

17 1Effigel

18 5Grofenac

19 2Grofenac Retard

20 4Inflamac

21 2Inflamac Lotion

22 2Inflamac retard

23 1Misofenac

24 9Olfen

25 3Olfen duo release

26 2Olfen retard

27 2Pennsaid

28 2Primofenac emulsion gel

29 2Solacutan

30 3Solaraze

31 13Voltaren

32 5Voltaren Retard

33 8Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Laboratoires Théa

BioProcess International

Not Confirmed

Laboratoires Théa

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

diclofenac sodium

Brand Name : Dicloabak

Dosage Form : EYE DROPS, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Pfizer

BioProcess International

Not Confirmed

Pfizer

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

Several substances refer to content

Brand Name : Arthrotec

Dosage Form : MODIFIED-RELEASE TABLET

Dosage Strength : 50 MG / 0.2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

03

Pfizer

BioProcess International

Not Confirmed

Pfizer

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

Several substances refer to content

Brand Name : Arthrotec

Dosage Form : MODIFIED-RELEASE TABLET

Dosage Strength : -

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

04

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : GEL

Dosage Strength : 1%

Packaging : 45 G/Tube

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

05

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

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

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : GEL

Dosage Strength : 5%

Packaging : 45 G/Tube

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

06

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : SUPPOSITORY

Dosage Strength : 100MG

Packaging : 5 Or 10 Suppositories

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

07

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : INJECTABLE

Dosage Strength : 75MG/3ML

Packaging : 5 Ampoules

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

08

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : RETARD TABLET

Dosage Strength : 100MG

Packaging : 10 Or 20 Or 30 Tablets

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

09

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

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Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium; Thiamine; Pyridoxine; Cobamet

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 50MG; 50MG; 50MG; 0.25MG

Packaging : 20 Capsules

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

10

World Medicine Ilac San ve tic LTD STl

BioProcess International

Not Confirmed

World Medicine Ilac San ve tic LTD STl

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

Regulatory Info : Generic

Registration Country : Turkey

Diclofenac Sodium

Brand Name :

Dosage Form : EYE DROPS

Dosage Strength : 1%

Packaging : 5 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

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