Simvastatin | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Simvastatin
Australia

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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Simvastatin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 37 USDMF, 42 CEP/COS, 7 JDMF, 8 EU WC, 44 KDMF, 13 NDC API, 19 Listed Suppliers, $ API Reference Price

94 API Suppliers
37 USDMF
42 CEP/COS
7 JDMF
8 EU WC
44 KDMF
13 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1319 FDF Dossiers, 141 FDA Orange Book, 832 Europe, 70 Canada, 114 Australia, 90 South Africa, 72 Listed Dossiers

1319 FDF Dossiers
141 FDA Orange Book
832 Europe
70 Canada
114 Australia
90 South Africa
72 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- 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL -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TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 26 BASF, 2 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 31 Thickeners and Stabilizers, 31 Direct Compression, 29 Granulation, 24 Controlled & Modified Release, 20 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 19 Solubilizers, 17 Film Formers & Plasticizers, 16 Topical, 13 Taste Masking, 11 Co-Processed Excipients, 10 Parenteral, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 2 Coloring Agents

54 Fillers, Diluents & Binders
45 Coating Systems & Additives
31 Thickeners and Stabilizers
31 Direct Compression
29 Granulation
24 Controlled & Modified Release
20 Lubricants & Glidants
19 Disintegrants & Superdisintegrants
19 Solubilizers
17 Film Formers & Plasticizers
16 Topical
13 Taste Masking
11 Co-Processed Excipients
10 Parenteral
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 API Stability Enhancers
5 Rheology Modifiers
5 Empty Capsules
4 Vegetarian Capsules
3 Surfactant & Foaming Agents
2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 50 News #PharmaBuzz

1 Data Compilation #PharmaFlow
50 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 292 Regulatory FDF Prices, 15 Annual Reports

27 US Medicaid Prescriptions
292 Regulatory FDF Prices
15 Annual Reports

MARKET PLACE

22 APIs, 6 FDF Dossiers

22 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents

16 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 9 Others

2 EDQM
1 USP
4 JP
9 Others

ANALYTICAL

7 BioAnalytical Methods

7 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 217 Xls

Filters

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Filters

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filter Applicant Reset all filters

114 All

01 34Alphapharm Pty Ltd

02 16Apotex Pty Ltd

03 16Arrow Pharma Pty Ltd

04 6Generic Health Pty Ltd

05 8Pharmacor Pty Limited

06 18Sandoz Pty Ltd

07 16WAGNER PHARMACEUTICALS PTY LTD

filter Active Ingredients Reset all filters

114 All

01 62Ezetimibe + simvastatin

02 52Simvastatin

filter Dosage Form Reset all filters

114 All

01 62Tablet

02 52tablet

filter Brand Name Reset all filters

114 All

01 2APO-Ezetimibe/Simvastatin 10/10

02 2APO-Ezetimibe/Simvastatin 10/20

03 2APO-Ezetimibe/Simvastatin 10/40

04 2APO-Ezetimibe/Simvastatin 10/80

05 8APO-Simvastatin

06 8EZETIMIBE/SIMVASTATIN SANDOZ

07 2EZETIMIBE/SIMVASTATIN-WGR 10/10

08 2EZETIMIBE/SIMVASTATIN-WGR 10/20

09 2EZETIMIBE/SIMVASTATIN-WGR 10/40

10 2EZETIMIBE/SIMVASTATIN-WGR 10/80

11 8EZETORIN

12 2EzSimva GH 10/10

13 2EzSimva GH 10/20

14 2EzSimva GH 10/80

15 2Lipex 20

16 2Lipex 40

17 2Pharmacor Ezetimibe Simvastatin 10/10

18 2Pharmacor Ezetimibe Simvastatin 10/20

19 2Pharmacor Ezetimibe Simvastatin 10/40

20 2Pharmacor Ezetimibe Simvastatin 10/80

21 8SIMVASTATIN-WGR

22 2Simvar 10

23 2Simvar 20

24 2Simvar 40

25 2Simvar 80

26 10Simvastatin Sandoz

27 8Vytorin

28 10Zimstat

29 2Zimybe 10/10

30 2Zimybe 10/20

31 2Zimybe 10/40

32 2Zimybe 10/80

33 4Zocor

List of Suppliers

Product Main Page

01

Alphapharm Pty Ltd

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Alphapharm Pty Ltd

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

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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Alphapharm Pty Ltd

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Digital Content

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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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

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04

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

Ezetimibe + simvastatin

Brand Name : Vytorin

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

Ezetimibe + simvastatin

Brand Name : Zimybe 10/10

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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06

Alphapharm Pty Ltd

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Digital Content

Regulatory Info :

Registration Country : Australia

Ezetimibe + simvastatin

Brand Name : Vytorin

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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07

Alphapharm Pty Ltd

RNA Leaders

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Alphapharm Pty Ltd

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Digital Content

Regulatory Info :

Registration Country : Australia

Ezetimibe + simvastatin

Brand Name : Zimybe 10/20

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Alphapharm Pty Ltd

RNA Leaders

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Alphapharm Pty Ltd

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Digital Content

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

09

Alphapharm Pty Ltd

RNA Leaders

Not Confirmed

Alphapharm Pty Ltd

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Digital Content

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10

Alphapharm Pty Ltd

RNA Leaders

Not Confirmed

Alphapharm Pty Ltd

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

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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