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Drug Approvals by the Medicines Control Council in South Africa containing Prestwick3_000958. Original Data : South African Medicines Price Registry

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Product

Prestwick3_000958
South Africa

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Sichuan Elixir Pharmaceuticals Ursodeoxycholic Acid

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xyz-pharma-m-2024-09-09

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PharmaCompass Sponsored Ads

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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_000958

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

66 API Suppliers, 22 USDMF, 21 CEP/COS, 12 JDMF, 3 EU WC, 14 KDMF, 18 NDC API, 34 Listed Suppliers, $ API Reference Price

66 API Suppliers
22 USDMF
21 CEP/COS
12 JDMF
3 EU WC
14 KDMF
18 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports

API Reference Price
API Exports
API Imports
FDF Exports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

210 FDF Dossiers, 34 FDA Orange Book, 115 Europe, 11 Canada, 5 Australia, 2 South Africa, 43 Listed Dossiers

210 FDF Dossiers
34 FDA Orange Book
115 Europe
11 Canada
5 Australia
2 South Africa
43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG, TABLET;ORAL - 250MG, TABLET;ORAL - 500MG

CAPSULE;ORAL - 300MG
TABLET;ORAL - 250MG
TABLET;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 11 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 2 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 29 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 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, 26 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 37 Direct Compression, 32 Thickeners and Stabilizers, 32 Controlled & Modified Release, 26 Granulation, 25 Film Formers & Plasticizers, 21 Disintegrants & Superdisintegrants, 20 Topical, 20 Solubilizers, 18 Co-Processed Excipients, 18 Taste Masking, 16 Lubricants & Glidants, 12 Parenteral, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 6 Rheology Modifiers, 5 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

79 Fillers, Diluents & Binders
54 Coating Systems & Additives
37 Direct Compression
32 Thickeners and Stabilizers
32 Controlled & Modified Release
26 Granulation
25 Film Formers & Plasticizers
21 Disintegrants & Superdisintegrants
20 Topical
20 Solubilizers
18 Co-Processed Excipients
18 Taste Masking
16 Lubricants & Glidants
12 Parenteral
9 Chewable & Orodispersible Aids
9 Empty Capsules
6 Rheology Modifiers
5 Emulsifying Agents
5 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
3 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 107 Finished Drug Prices, 2 Annual Reports

3 US Medicaid Prescriptions
107 Finished Drug Prices
2 Annual Reports

MARKET PLACE

29 APIs, 12 FDF Dossiers

29 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 8 Others

4 EDQM
1 USP
8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 317 Xls

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01 1Sanofi Aventis South Africa (Pty) Ltd

02 1Cipla Medpro (Pty) Ltd

filter Active Ingredients Reset all filters

2 All

01 1Ursodeoxycholic Acid

02 1Ursodeoxycholic acid

filter Dosage Form Reset all filters

2 All

01 1CAP

02 1TAB

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2 All

01 1Ursofalk

02 1Ursotan

Axplora Ursodeoxycholic Acid

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

CPhI Worldwide, Milan

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ursodeoxycholic Acid

Brand Name : Ursotan

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 180X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

02

Cipla Medpro (Pty) Ltd

Formnext Forum

Not Confirmed

Cipla Medpro (Pty) Ltd

Formnext Forum

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ursodeoxycholic acid

Brand Name : Ursofalk

Dosage Form : CAP

Dosage Strength : 250mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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