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Australian Register of Therapeutic Goods list of Approved Drug Products containing Prestwick3_000865. Original Data : Therapeutic Goods Administration Website

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Product

Prestwick3_000865
Australia

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_000865

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 39 USDMF, 41 CEP/COS, 6 JDMF, 10 EU WC, 50 KDMF, 11 NDC API, 17 Listed Suppliers, $ API Reference Price

71 API Suppliers
39 USDMF
41 CEP/COS
6 JDMF
10 EU WC
50 KDMF
11 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 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

971 FDF Dossiers, 128 FDA Orange Book, 572 Europe, 65 Canada, 50 Australia, 86 South Africa, 70 Listed Dossiers

971 FDF Dossiers
128 FDA Orange Book
572 Europe
65 Canada
50 Australia
86 South Africa
70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

TABLET;ORAL - 10MG
TABLET;ORAL - 20MG
TABLET;ORAL - 40MG
TABLET;ORAL - 5MG
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SUSPENSION;ORAL - 20MG/5ML
SUSPENSION;ORAL - 40MG/5ML
TABLET;ORAL - 10MG;10MG
TABLET;ORAL - 10MG;20MG
TABLET;ORAL - 10MG;40MG
TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 30 Controlled & Modified Release, 27 Thickeners and Stabilizers, 24 Granulation, 22 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 20 Solubilizers, 18 Film Formers & Plasticizers, 16 Co-Processed Excipients, 15 Topical, 12 Taste Masking, 9 Parenteral, 7 API Stability Enhancers, 6 Emulsifying Agents, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 48 NEWS #PharmaBuzz

7 DATA COMPILATION #PharmaFlow
48 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 525 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
525 Finished Drug Prices
10 Annual Reports

MARKET PLACE

18 APIs, 6 FDF Dossiers

18 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 5 Health Canada Patents

16 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 4 JP, 11 Others

2 EDQM
5 USP
4 JP
11 Others

ANALYTICAL

7 BioAnalytical Methods

7 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 227 Xls

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01 18Alphapharm Pty Ltd

02 8Apotex Pty Ltd

03 8Arrow Pharma Pty Ltd

04 6Avallon Pharmaceuticals Pty Limited

05 10Sandoz Pty Ltd

filter Active Ingredients Reset all filters

50 All

01 50simvastatin

filter Dosage Form Reset all filters

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01 50tablet

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01 8APO-Simvastatin

02 2Lipex 20

03 2Lipex 40

04 6NOUMED SIMVASTATIN

05 2Simvar 10

06 2Simvar 20

07 2Simvar 40

08 2Simvar 80

09 10Simvastatin Sandoz

10 10Zimstat

11 4Zocor

FDF Dossiers
FDA Orange Book
Europe
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Australia
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Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Zimstat

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Lipex 20

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Zocor

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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Corporate PDF

04

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Zimstat

Dosage Form : tablet

Dosage Strength : 40 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Alphapharm Pty Ltd

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Digital Content

Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Lipex 40

Dosage Form : tablet

Dosage Strength : 40 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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Corporate PDF

06

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Zocor

Dosage Form : tablet

Dosage Strength : 40 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Product Web Link

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Apotex Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : APO-Simvastatin

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Simvar 20

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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09

Avallon Pharmaceuticals Pty Limited

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Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : NOUMED SIMVASTATIN

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Sandoz Pty Ltd

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Sandoz Pty Ltd

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Digital Content

Regulatory Info :

Registration Country : Australia

simvastatin

Brand Name : Simvastatin Sandoz

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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