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Australian Register of Therapeutic Goods list of Approved Drug Products containing Prestwick3_000958. Original Data : Therapeutic Goods Administration Website

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Product

Prestwick3_000958
Australia

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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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5 All

01 1Apotex Pty Ltd

02 1Boucher & Muir Pty Ltd

03 2Dr Falk Pharma Australia Pty Ltd

04 1Generic Health Pty Ltd

filter Active Ingredients Reset all filters

5 All

01 5ursodeoxycholic acid

filter Dosage Form Reset all filters

5 All

01 4capsule

02 1Blank

filter Brand Name Reset all filters

5 All

01 1APO-Ursodeoxycholic acid

02 1Ursodox GH

03 2Ursofalk

04 1Ursosan

Axplora Ursodeoxycholic Acid

FDF Dossiers
FDA Orange Book
Europe
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01

Apotex Pty Ltd

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Apotex Pty Ltd

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Regulatory Info :

Registration Country : Australia

ursodeoxycholic acid

Brand Name : APO-Ursodeoxycholic acid

Dosage Form : capsule

Dosage Strength : 250 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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02

Boucher & Muir Pty Ltd

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Boucher & Muir Pty Ltd

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Regulatory Info :

Registration Country : Australia

ursodeoxycholic acid

Brand Name : Ursosan

Dosage Form : capsule

Dosage Strength : 250 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Dr Falk Pharma Australia Pty Ltd

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Dr Falk Pharma Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

ursodeoxycholic acid

Brand Name : Ursofalk

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Dr Falk Pharma Australia Pty Ltd

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Dr Falk Pharma Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

ursodeoxycholic acid

Brand Name : Ursofalk

Dosage Form : capsule

Dosage Strength : 250 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Generic Health Pty Ltd

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Generic Health Pty Ltd

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Regulatory Info :

Registration Country : Australia

ursodeoxycholic acid

Brand Name : Ursodox GH

Dosage Form : capsule

Dosage Strength : 250 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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