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Drug Approvals by the Medicines Control Council in South Africa containing Phenytoin. Original Data : South African Medicines Price Registry

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Product

Phenytoin
Phenytoin Sodium
Benzophenone
Mephenytoin
Fosphenytoin Sodium
South Africa

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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Phenytoin

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 2 USDMF, 1 CEP/COS, 2 JDMF, 3 EU WC, 11 NDC API, 6 Listed Suppliers, $ API Reference Price

9 API Suppliers
2 USDMF
1 CEP/COS
2 JDMF
3 EU WC
11 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

FINISHED DOSAGE FORMULATIONS

56 FDF Dossiers, 11 FDA Orange Book, 13 Europe, 4 Canada, 8 Australia, 6 South Africa, 14 Listed Dossiers

56 FDF Dossiers
11 FDA Orange Book
13 Europe
4 Canada
8 Australia
6 South Africa
14 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 3 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 8 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 8 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 26 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 6 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 5 Sigachi Industries, 3 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Fillers, Diluents & Binders, 41 Coating Systems & Additives, 20 Controlled & Modified Release, 18 Direct Compression, 17 Solubilizers, 17 Thickeners and Stabilizers, 13 Lubricants & Glidants, 10 Emulsifying Agents, 10 Parenteral, 10 Co-Processed Excipients, 9 Film Formers & Plasticizers, 8 Taste Masking, 7 Granulation, 6 Disintegrants & Superdisintegrants, 6 Topical, 6 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Chewable & Orodispersible Aids, 2 Coloring Agents

44 Fillers, Diluents & Binders
41 Coating Systems & Additives
20 Controlled & Modified Release
18 Direct Compression
17 Solubilizers
17 Thickeners and Stabilizers
13 Lubricants & Glidants
10 Emulsifying Agents
10 Parenteral
10 Co-Processed Excipients
9 Film Formers & Plasticizers
8 Taste Masking
7 Granulation
6 Disintegrants & Superdisintegrants
6 Topical
6 Rheology Modifiers
5 Surfactant & Foaming Agents
5 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Chewable & Orodispersible Aids
2 Coloring Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 9 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 16 Finished Drug Prices

3 US Medicaid Prescriptions
16 Finished Drug Prices

MARKET PLACE

2 APIs, 2 FDF Dossiers

2 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 3 Others

2 EDQM
2 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 26 Xls

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6 All

01 2Pharmacare Limited, Woodmead

02 1Pfizer Laboratories (Pty) Ltd

03 2UpJohn South Africa (Pty) Ltd

04 1Viatris Healthcare (Pty) Ltd

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6 All

01 6Phenytoin

filter Dosage Form Reset all filters

6 All

01 1CAP

02 1INJ

03 1SUS

04 3TAB

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6 All

01 1Epanutin 100mg

02 1Epanutin Forte Suspension

03 1Epanutin Infatabs

04 1Epanutin Ready Mixed Parenteral (injection)

05 1Phenytoin

06 1Phenytoin Sodium

FDF Dossiers
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South Africa
Listed Dossiers

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01

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Phenytoin Sodium

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 1000X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Phenytoin

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pfizer Laboratories (Pty) Ltd

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Pfizer Laboratories (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epanutin Infatabs

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 100X1mg

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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04

UpJohn South Africa (Pty) Ltd

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UpJohn South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epanutin 100mg

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

UpJohn South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epanutin Ready Mixed Parenteral (injection)

Dosage Form : INJ

Dosage Strength : 250mg/5ml

Packaging : 5X10mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Viatris Healthcare (Pty) Ltd

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Viatris Healthcare (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epanutin Forte Suspension

Dosage Form : SUS

Dosage Strength : 125mg/5ml

Packaging : 237X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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