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Drug Approvals by the Medicines Control Council in South Africa containing Prestwick3_000142. Original Data : South African Medicines Price Registry

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Product

Prestwick3_000142
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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Prestwick3_000142

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 19 USDMF, 10 CEP/COS, 6 JDMF, 3 EU WC, 7 NDC API, 9 Listed Suppliers, $ API Reference Price

33 API Suppliers
19 USDMF
10 CEP/COS
6 JDMF
3 EU WC
7 NDC API
9 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

80 FDF Dossiers, 52 FDA Orange Book, 10 Europe, 3 Canada, 5 South Africa, 10 Listed Dossiers

80 FDF Dossiers
52 FDA Orange Book
10 Europe
3 Canada
5 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, TABLET;ORAL - 75MG, CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
TABLET;ORAL - 75MG
CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik, 2 Rochem International Inc, 7 SPI Pharma, 2 Seqens, 10 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 1 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 16 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

80 Coating Systems & Additives, 78 Fillers, Diluents & Binders, 48 Controlled & Modified Release, 36 Direct Compression, 32 Thickeners and Stabilizers, 30 Solubilizers, 25 Granulation, 22 Disintegrants & Superdisintegrants, 21 Topical, 21 Film Formers & Plasticizers, 20 Lubricants & Glidants, 16 Parenteral, 16 Co-Processed Excipients, 15 Taste Masking, 10 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

80 Coating Systems & Additives
78 Fillers, Diluents & Binders
48 Controlled & Modified Release
36 Direct Compression
32 Thickeners and Stabilizers
30 Solubilizers
25 Granulation
22 Disintegrants & Superdisintegrants
21 Topical
21 Film Formers & Plasticizers
20 Lubricants & Glidants
16 Parenteral
16 Co-Processed Excipients
15 Taste Masking
10 Emulsifying Agents
9 Empty Capsules
9 API Stability Enhancers
6 Rheology Modifiers
6 Chewable & Orodispersible Aids
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 19 Finished Drug Prices

1 US Medicaid Prescriptions
19 Finished Drug Prices

MARKET PLACE

9 APIs, 4 FDF Dossiers

9 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 7 USP, 7 Others

2 EDQM
7 USP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 249 Xls

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filter Applicant Reset all filters

5 All

01 2Pharmacare Limited, Woodmead

02 3Ingelheim Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 5Dipyridamole

filter Dosage Form Reset all filters

5 All

01 2CAP

02 1INJ

03 2TAB

filter Brand Name Reset all filters

5 All

01 1Asasantin 200/25 Retard

02 1Persantin 10mg/2ml

03 1Persantin 200 Retard

04 2Plato

FDF Dossiers
FDA Orange Book
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Canada
South Africa
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01

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Dipyridamole

Brand Name : Plato

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

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

Dipyridamole

Brand Name : Plato

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Ingelheim Pharmaceuticals (Pty) Ltd

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Ingelheim Pharmaceuticals (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Dipyridamole

Brand Name : Persantin 10mg/2ml

Dosage Form : INJ

Dosage Strength : 10mg/2ml

Packaging : 2X5mg/2ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Ingelheim Pharmaceuticals (Pty) Ltd

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Ingelheim Pharmaceuticals (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dipyridamole

Brand Name : Asasantin 200/25 Retard

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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05

Ingelheim Pharmaceuticals (Pty) Ltd

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Ingelheim Pharmaceuticals (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dipyridamole

Brand Name : Persantin 200 Retard

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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