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Drug Approvals by the Medicines Control Council in South Africa containing Prestwick2_000881. Original Data : South African Medicines Price Registry

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Product

Prestwick2_000881
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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Prestwick2_000881

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 9 USDMF, 3 CEP/COS, 1 JDMF, 5 EU WC, 4 NDC API, 10 Listed Suppliers, $ API Reference Price

21 API Suppliers
9 USDMF
3 CEP/COS
1 JDMF
5 EU WC
4 NDC API
10 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

81 FDF Dossiers, 54 FDA Orange Book, 4 Europe, 1 Canada, 2 South Africa, 20 Listed Dossiers

81 FDF Dossiers
54 FDA Orange Book
4 Europe
1 Canada
2 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 14 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 15 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 17 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 50 Thickeners and Stabilizers, 47 Direct Compression, 45 Controlled & Modified Release, 41 Solubilizers, 39 Taste Masking, 30 Granulation, 29 Topical, 29 Parenteral, 29 Lubricants & Glidants, 28 Film Formers & Plasticizers, 26 Disintegrants & Superdisintegrants, 23 Chewable & Orodispersible Aids, 22 Co-Processed Excipients, 14 Emulsifying Agents, 13 Rheology Modifiers, 11 API Stability Enhancers, 9 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

111 Fillers, Diluents & Binders
75 Coating Systems & Additives
50 Thickeners and Stabilizers
47 Direct Compression
45 Controlled & Modified Release
41 Solubilizers
39 Taste Masking
30 Granulation
29 Topical
29 Parenteral
29 Lubricants & Glidants
28 Film Formers & Plasticizers
26 Disintegrants & Superdisintegrants
23 Chewable & Orodispersible Aids
22 Co-Processed Excipients
14 Emulsifying Agents
13 Rheology Modifiers
11 API Stability Enhancers
9 Empty Capsules
7 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices

3 US Medicaid Prescriptions
11 Finished Drug Prices

MARKET PLACE

17 APIs, 1 Intermediates

17 APIs
1 Intermediates

PATENTS & EXCLUSIVITIES

12 Health Canada Patents

12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 2 JP, 4 Others

2 EDQM
4 USP
2 JP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 6 Xls

Filters

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FILTER :

filter Applicant Reset all filters

2 All

01 1Pharmacare Limited, Woodmead

02 1MSD (Pty) Ltd

filter Active Ingredients Reset all filters

2 All

01 1Niacin

02 1Nicotinic acid

filter Dosage Form Reset all filters

2 All

01 1CAP

02 1TAB

filter Brand Name Reset all filters

2 All

01 1Filibon

02 1Tredaptive

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Nicotinic acid

Brand Name : Filibon

Dosage Form : CAP

Dosage Strength : 10u

Packaging : 30X1u

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

MSD (Pty) Ltd

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MSD (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Tredaptive

Dosage Form : TAB

Dosage Strength : 1000mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Digital Content

Corporate PDF

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