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Australian Register of Therapeutic Goods list of Approved Drug Products containing Prestwick3_000314. Original Data : Therapeutic Goods Administration Website

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Product

Prestwick3_000314
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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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_000314

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 17 USDMF, 13 CEP/COS, 4 JDMF, 5 EU WC, 9 KDMF, 10 NDC API, 15 Listed Suppliers, $ API Reference Price

36 API Suppliers
17 USDMF
13 CEP/COS
4 JDMF
5 EU WC
9 KDMF
10 NDC API
15 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

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

752 FDF Dossiers, 90 FDA Orange Book, 456 Europe, 46 Canada, 30 Australia, 44 South Africa, 86 Listed Dossiers

752 FDF Dossiers
90 FDA Orange Book
456 Europe
46 Canada
30 Australia
44 South Africa
86 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 2.5MG
TABLET;ORAL - 20MG
TABLET;ORAL - 5MG
TABLET;ORAL - 10MG;25MG
TABLET;ORAL - 5MG;12.5MG
FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 2 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Novo Excipients, 1 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, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 31 Direct Compression, 22 Controlled & Modified Release, 20 Granulation, 19 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 15 Co-Processed Excipients, 14 Thickeners and Stabilizers, 11 Taste Masking, 9 Film Formers & Plasticizers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Coloring Agents, 2 Topical, 2 Parenteral, 1 Surfactant & Foaming Agents, 1 Solubilizers

62 Fillers, Diluents & Binders
45 Coating Systems & Additives
31 Direct Compression
22 Controlled & Modified Release
20 Granulation
19 Lubricants & Glidants
19 Disintegrants & Superdisintegrants
15 Co-Processed Excipients
14 Thickeners and Stabilizers
11 Taste Masking
9 Film Formers & Plasticizers
6 Chewable & Orodispersible Aids
5 Empty Capsules
5 API Stability Enhancers
4 Emulsifying Agents
4 Vegetarian Capsules
3 Rheology Modifiers
3 Coloring Agents
2 Topical
2 Parenteral
1 Surfactant & Foaming Agents
1 Solubilizers

DIGITAL CONTENT

29 NEWS #PharmaBuzz

29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 385 Finished Drug Prices

2 US Medicaid Prescriptions
385 Finished Drug Prices

MARKET PLACE

21 APIs, 12 FDF Dossiers

21 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

29 US Patents, 10 Health Canada Patents

29 US Patents
10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 JP, 4 Others

2 EDQM
1 USP
3 JP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 194 Xls

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01 10Alphapharm Pty Ltd

02 6Apotex Pty Ltd

03 6Arrow Pharma Pty Ltd

04 2Generic Health Pty Ltd

05 6Sandoz Pty Ltd

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01 30enalapril

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01 30tablet

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01 6APO-Enalapril

02 6Acetec

03 6Enalapril Sandoz

04 2Enalapril generichealth

05 6Malean

06 2Renitec

07 2Renitec 20

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Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Acetec

Dosage Form : tablet

Dosage Strength : 5 mg

Packaging : 30

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Brand Name : Renitec 20

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Regulatory Info :

Registration Country : Australia

Brand Name : Acetec

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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Regulatory Info :

Registration Country : Australia

Brand Name : APO-Enalapril

Dosage Form : tablet

Dosage Strength : 5 mg

Packaging : 30

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Registration Country : Australia

Brand Name : APO-Enalapril

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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Registration Country : Australia

Brand Name : Malean

Dosage Form : tablet

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Regulatory Info :

Registration Country : Australia

Brand Name : Malean

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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Registration Country : Australia

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Generic Health Pty Ltd

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Registration Country : Australia

Brand Name : Enalapril generichealth

Dosage Form : tablet

Dosage Strength : 20 mg

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Sandoz Pty Ltd

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Registration Country : Australia

Brand Name : Enalapril Sandoz

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Enalapril Sandoz

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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