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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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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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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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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pharmacompass-2-m-2025-10-20

Simvastatin

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 37 USDMF, 42 CEP/COS, 7 JDMF, 7 EU WC, 45 KDMF, 12 NDC API, 20 Listed Suppliers, $ API Reference Price

94 API Suppliers
37 USDMF
42 CEP/COS
7 JDMF
7 EU WC
45 KDMF
12 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

88 Drugs in Development

88 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1150 FDF Dossiers, 140 FDA Orange Book, 729 Europe, 70 Canada, 52 Australia, 88 South Africa, 71 Listed Dossiers

1150 FDF Dossiers
140 FDA Orange Book
729 Europe
70 Canada
52 Australia
88 South Africa
71 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- 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL -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TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 9 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 5 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, 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, 47 Coating Systems & Additives, 35 Thickeners and Stabilizers, 31 Direct Compression, 29 Granulation, 24 Controlled & Modified Release, 20 Lubricants & Glidants, 19 Solubilizers, 19 Disintegrants & Superdisintegrants, 17 Film Formers & Plasticizers, 16 Topical, 13 Taste Masking, 10 Rheology Modifiers, 10 Parenteral, 10 Co-Processed Excipients, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 50 News #PharmaBuzz

1 Data Compilation #PharmaFlow
50 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 347 Regulatory FDF Prices, 15 Annual Reports

27 US Medicaid Prescriptions
347 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) : 218 Xls

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01 18Alphapharm Pty Ltd

02 8Apotex Pty Ltd

03 8Arrow Pharma Pty Ltd

04 10Sandoz Pty Ltd

05 8WAGNER PHARMACEUTICALS PTY LTD

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52 All

01 52Simvastatin

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52 All

01 52tablet

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52 All

01 8APO-Simvastatin

02 2Lipex 20

03 2Lipex 40

04 8SIMVASTATIN-WGR

05 2Simvar 10

06 2Simvar 20

07 2Simvar 40

08 2Simvar 80

09 10Simvastatin Sandoz

10 10Zimstat

11 4Zocor

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01

Alphapharm Pty Ltd

OTS 2025

Not Confirmed

Alphapharm Pty Ltd

OTS 2025

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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

Portfolio PDF

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Digital Content

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02

Alphapharm Pty Ltd

OTS 2025

Not Confirmed

Alphapharm Pty Ltd

OTS 2025

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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

OTS 2025

Not Confirmed

Alphapharm Pty Ltd

OTS 2025

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Digital Content

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

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04

Alphapharm Pty Ltd

OTS 2025

Not Confirmed

Alphapharm Pty Ltd

OTS 2025

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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 : 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

OTS 2025

Not Confirmed

Alphapharm Pty Ltd

OTS 2025

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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

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06

Alphapharm Pty Ltd

OTS 2025

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Alphapharm Pty Ltd

OTS 2025

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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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07

Apotex Pty Ltd

OTS 2025

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Apotex Pty Ltd

OTS 2025

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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 :

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Regulatory Info :

Registration Country : Australia

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08

Arrow Pharma Pty Ltd

OTS 2025

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Arrow Pharma Pty Ltd

OTS 2025

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Digital Content

Regulatory Info :

Registration Country : Australia

Simvastatin

Brand Name : Simvar 20

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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Regulatory Info :

Registration Country : Australia

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Sandoz Pty Ltd

OTS 2025

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

Simvastatin

Brand Name : Simvastatin Sandoz

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

Approval Date :

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Regulatory Info :

Registration Country : Australia

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10

WAGNER PHARMACEUTICALS PTY LTD

Country

OTS 2025

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WAGNER PHARMACEUTICALS PTY LTD

Country

OTS 2025

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Regulatory Info :

Registration Country : Australia

Simvastatin

Brand Name : SIMVASTATIN-WGR

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 30

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Regulatory Info :

Registration Country : Australia

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