Fenofibric Acid | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Fenofibric Acid
Australia

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Fenofibric Acid

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 29 USDMF, 16 CEP/COS, 4 JDMF, 16 EU WC, 28 KDMF, 18 NDC API, 45 Listed Suppliers, $ API Reference Price

73 API Suppliers
29 USDMF
16 CEP/COS
4 JDMF
16 EU WC
28 KDMF
18 NDC API
45 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

280 FDF Dossiers, 129 FDA Orange Book, 52 Europe, 12 Canada, 28 Australia, 2 South Africa, 57 Listed Dossiers

280 FDF Dossiers
129 FDA Orange Book
52 Europe
12 Canada
28 Australia
2 South Africa
57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 160MG, CAPSULE;ORAL - 150MG, CAPSULE;ORAL - 50MG, TABLET;ORAL - 145MG, TABLET;ORAL - 48MG, CAPSULE;ORAL - 130MG, CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 43MG, CAPSULE;ORAL - 90MG, TABLET;ORAL - 105MG, TABLET;ORAL - 35MG

TABLET;ORAL - 160MG
CAPSULE;ORAL - 150MG
CAPSULE;ORAL - 50MG
TABLET;ORAL - 145MG
TABLET;ORAL - 48MG
CAPSULE;ORAL - 130MG
CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 43MG
CAPSULE;ORAL - 90MG
TABLET;ORAL - 105MG
TABLET;ORAL - 35MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 19 SPI Pharma, 3 Seqens, 11 DKSH, 3 Jai Radhe Sales, 1 PMC Isochem, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 2 Kewpie Corporation, 14 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Bioplus Life Sciences, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 14 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 3 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 15 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

100 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 55 Direct Compression, 52 Thickeners and Stabilizers, 52 Solubilizers, 48 Disintegrants & Superdisintegrants, 36 Controlled & Modified Release, 35 Granulation, 32 Taste Masking, 29 Topical, 27 Lubricants & Glidants, 24 Parenteral, 23 Film Formers & Plasticizers, 22 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 17 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 7 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

100 Fillers, Diluents & Binders
57 Coating Systems & Additives
55 Direct Compression
52 Thickeners and Stabilizers
52 Solubilizers
48 Disintegrants & Superdisintegrants
36 Controlled & Modified Release
35 Granulation
32 Taste Masking
29 Topical
27 Lubricants & Glidants
24 Parenteral
23 Film Formers & Plasticizers
22 Co-Processed Excipients
21 Chewable & Orodispersible Aids
17 Emulsifying Agents
10 API Stability Enhancers
9 Empty Capsules
7 Rheology Modifiers
7 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 59 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
59 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 59 Finished Drug Prices

8 US Medicaid Prescriptions
59 Finished Drug Prices

MARKET PLACE

23 APIs, 5 FDF Dossiers

23 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

28 US Patents, 10 Health Canada Patents

28 US Patents
10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 5 Others

4 EDQM
4 USP
5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 84 Xls

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01 4Alphapharm Pty Ltd

02 6Apotex Pty Ltd

03 2Arrotex Pharmaceuticals Pty Ltd

04 4Cipla Australia Pty Ltd

05 4Sandoz Pty Ltd

06 4Sun Pharma ANZ Pty Ltd

07 4Viatris Pty Ltd

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28 All

01 28fenofibrate

filter Dosage Form Reset all filters

28 All

01 28tablet

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28 All

01 4APO-Fenofibrate

02 2BTC Fenofibrate

03 2Blooms the Chemist Fenofibrate

04 4FENOFIBRATE RBX

05 2Fenocol

06 4Fenofibrate Cipla

07 2Fenofibrate Sandoz

08 4Fenofibrate Viatris

09 4Lipidil

List of Suppliers

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01

Alphapharm Pty Ltd

2024 ACI Convention

Not Confirmed

Alphapharm Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : Fenofibrate Viatris

Dosage Form : tablet

Dosage Strength : 48 mg

Packaging : 60

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Registration Country : Australia

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02

Alphapharm Pty Ltd

2024 ACI Convention

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Alphapharm Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : Fenofibrate Viatris

Dosage Form : tablet

Dosage Strength : 145 mg

Packaging : 30

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Regulatory Info :

Registration Country : Australia

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03

Apotex Pty Ltd

2024 ACI Convention

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Apotex Pty Ltd

2024 ACI Convention

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Registration Country : Australia

fenofibrate

Brand Name : APO-Fenofibrate

Dosage Form : tablet

Dosage Strength : 48 mg

Packaging : 60

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Registration Country : Australia

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04

Apotex Pty Ltd

2024 ACI Convention

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Apotex Pty Ltd

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Registration Country : Australia

fenofibrate

Brand Name : Blooms the Chemist Fenofibrate

Dosage Form : tablet

Dosage Strength : 145 mg

Packaging : 30

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Regulatory Info :

Registration Country : Australia

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05

Cipla Australia Pty Ltd

2024 ACI Convention

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Cipla Australia Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : Fenofibrate Cipla

Dosage Form : tablet

Dosage Strength : 48 mg

Packaging : 60

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Registration Country : Australia

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Cipla Australia Pty Ltd

2024 ACI Convention

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Cipla Australia Pty Ltd

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Registration Country : Australia

fenofibrate

Brand Name : Fenofibrate Cipla

Dosage Form : tablet

Dosage Strength : 145 mg

Packaging : 30

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Registration Country : Australia

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07

Sandoz Pty Ltd

2024 ACI Convention

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Sandoz Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : BTC Fenofibrate

Dosage Form : tablet

Dosage Strength : 145 mg

Packaging : 30

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Registration Country : Australia

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08

Sun Pharma ANZ Pty Ltd

2024 ACI Convention

Not Confirmed

Sun Pharma ANZ Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : FENOFIBRATE RBX

Dosage Form : tablet

Dosage Strength : 48 mg

Packaging : 60

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09

Viatris Pty Ltd

2024 ACI Convention

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Viatris Pty Ltd

2024 ACI Convention

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Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : Lipidil

Dosage Form : tablet

Dosage Strength : 48 mg

Packaging : 60

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Application Number :

Regulatory Info :

Registration Country : Australia

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10

Viatris Pty Ltd

2024 ACI Convention

Not Confirmed

Viatris Pty Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

fenofibrate

Brand Name : Lipidil

Dosage Form : tablet

Dosage Strength : 145 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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