Fenitoina Sodica | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Fenitoina Sodica
Europe

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Fenitoina Sodica

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 11 USDMF, 2 CEP/COS, 4 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

25 API Suppliers
11 USDMF
2 CEP/COS
4 EU WC
9 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

73 FDF Dossiers, 38 FDA Orange Book, 5 Europe, 6 Canada, 2 South Africa, 22 Listed Dossiers

73 FDF Dossiers
38 FDA Orange Book
5 Europe
6 Canada
2 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML, CAPSULE;ORAL - 100MG EXTENDED, CAPSULE;ORAL - 30MG EXTENDED

INJECTABLE;INJECTION - 50MG/ML
CAPSULE;ORAL - 100MG EXTENDED
CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 13 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 16 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 20 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 26 Direct Compression, 25 Thickeners and Stabilizers, 24 Granulation, 19 Controlled & Modified Release, 16 Taste Masking, 15 Chewable & Orodispersible Aids, 15 Lubricants & Glidants, 11 Solubilizers, 11 Parenteral, 10 Co-Processed Excipients, 10 Disintegrants & Superdisintegrants, 9 Film Formers & Plasticizers, 9 Empty Capsules, 9 Topical, 7 Rheology Modifiers, 6 Emulsifying Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 1 Surfactant & Foaming Agents

58 Fillers, Diluents & Binders
44 Coating Systems & Additives
26 Direct Compression
25 Thickeners and Stabilizers
24 Granulation
19 Controlled & Modified Release
16 Taste Masking
15 Chewable & Orodispersible Aids
15 Lubricants & Glidants
11 Solubilizers
11 Parenteral
10 Co-Processed Excipients
10 Disintegrants & Superdisintegrants
9 Film Formers & Plasticizers
9 Empty Capsules
9 Topical
7 Rheology Modifiers
6 Emulsifying Agents
5 Coloring Agents
4 Vegetarian Capsules
4 API Stability Enhancers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 8 Regulatory FDF Prices

13 US Medicaid Prescriptions
8 Regulatory FDF Prices

MARKET PLACE

15 APIs, 3 FDF Dossiers

15 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM

1 EDQM

$ API Ref.Price (USD/KG) : 33 Xls

Filters

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Filters

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filter Applicant Reset all filters

5 All

01 1Accord Healthcare Slu

02 1Altan Pharmaceuticals Sa

03 1Kern Pharma Sl

04 1Rubio Laboratories Sa

05 1Viatris Healthcare Limited

filter Active Ingredients Reset all filters

5 All

01 5Phenytoin Sodium

filter Dosage Form Reset all filters

5 All

01 1Hard Capsule

02 4Injectable Solution

filter Country Reset all filters

5 All

01 5Spain

filter Brand Name Reset all filters

5 All

01 1Epanutin

02 1Fenitoina Altan

03 1Fenitoina Kern Pharma

04 1Phenytoin Accord

05 1Phenytoin Rubio

List of Suppliers

Product Main Page

01

Accord Healthcare Slu

Organic Process R&D

Not Confirmed

Accord Healthcare Slu

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Phenytoin Sodium

Brand Name : Phenytoin Accord

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2003-03-18

Application Number : 65303

Regulatory Info : Cancelled

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Altan Pharmaceuticals Sa

Organic Process R&D

Not Confirmed

Altan Pharmaceuticals Sa

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Phenytoin Sodium

Brand Name : Fenitoina Altan

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2003-05-27

Application Number : 65372

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Kern Pharma Sl

Organic Process R&D

Not Confirmed

Kern Pharma Sl

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Phenytoin Sodium

Brand Name : Fenitoina Kern Pharma

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2003-04-09

Application Number : 65340

Regulatory Info : Cancelled

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Rubio Laboratories Sa

Organic Process R&D

Not Confirmed

Rubio Laboratories Sa

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Phenytoin Sodium

Brand Name : Phenytoin Rubio

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 1984-07-01

Application Number : 56245

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Viatris Healthcare Limited

Organic Process R&D

Not Confirmed

Viatris Healthcare Limited

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Phenytoin Sodium

Brand Name : Epanutin

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date : 1968-03-01

Application Number : 45695

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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