NMI-131 | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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NMI-131
Australia

PharmaCompass Sponsored Ads

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Aspen API. More than just an API™

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jdmfs-not-supported-m-2025-04-28

NMI-131

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

99 API Suppliers, 34 USDMF, 10 JDMF, 15 EU WC, 29 KDMF, 32 NDC API, 39 Listed Suppliers, $ API Reference Price

99 API Suppliers
34 USDMF
10 JDMF
15 EU WC
29 KDMF
32 NDC API
39 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

14 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

486 FDF Dossiers, 127 FDA Orange Book, 244 Europe, 12 Canada, 14 Australia, 9 South Africa, 80 Listed Dossiers

486 FDF Dossiers
127 FDA Orange Book
244 Europe
12 Canada
14 Australia
9 South Africa
80 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 14MG, CAPSULE, EXTENDED RELEASE;ORAL - 21MG, CAPSULE, EXTENDED RELEASE;ORAL - 28MG, CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 5MG
CAPSULE, EXTENDED RELEASE;ORAL - 14MG
CAPSULE, EXTENDED RELEASE;ORAL - 21MG
CAPSULE, EXTENDED RELEASE;ORAL - 28MG
CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 2 Rochem International Inc, 8 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 26 BASF, 1 Bioplus Life Sciences, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 36 Controlled & Modified Release, 30 Thickeners and Stabilizers, 30 Disintegrants & Superdisintegrants, 26 Direct Compression, 26 Film Formers & Plasticizers, 26 Granulation, 22 Lubricants & Glidants, 20 Topical, 19 Taste Masking, 19 Solubilizers, 16 Parenteral, 13 Co-Processed Excipients, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

85 Fillers, Diluents & Binders
59 Coating Systems & Additives
36 Controlled & Modified Release
30 Thickeners and Stabilizers
30 Disintegrants & Superdisintegrants
26 Direct Compression
26 Film Formers & Plasticizers
26 Granulation
22 Lubricants & Glidants
20 Topical
19 Taste Masking
19 Solubilizers
16 Parenteral
13 Co-Processed Excipients
9 Chewable & Orodispersible Aids
9 Empty Capsules
7 Emulsifying Agents
7 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 86 News #PharmaBuzz

1 Data Compilation #PharmaFlow
86 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 174 Regulatory FDF Prices, 13 Annual Reports

3 US Medicaid Prescriptions
174 Regulatory FDF Prices
13 Annual Reports

MARKET PLACE

15 APIs, 5 FDF Dossiers

15 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

66 US Patents, 2 US Exclusivities, 2 Health Canada Patents

66 US Patents
2 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 15 Others

1 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 542 Xls

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14 All

01 4Apotex Pty Ltd

02 2Arrow Pharma Pty Ltd

03 4Generic Health Pty Ltd

04 4Lundbeck Australia Pty Ltd

filter Active Ingredients Reset all filters

14 All

01 14Memantine

filter Dosage Form Reset all filters

14 All

01 14tablet

filter Brand Name Reset all filters

14 All

01 4APO-Memantine

02 4Ebixa

03 4Memantine generichealth

04 2Memanxa

Memantine Hydrochloride

List of Suppliers

Product Main Page

01

Apotex Pty Ltd

ISPE Europe

Not Confirmed

Apotex Pty Ltd

ISPE Europe

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Regulatory Info :

Registration Country : Australia

Brand Name : APO-Memantine

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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Digital Content

Corporate PDF

02

Apotex Pty Ltd

ISPE Europe

Not Confirmed

Apotex Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : APO-Memantine

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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Corporate PDF

03

Arrow Pharma Pty Ltd

ISPE Europe

Not Confirmed

Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Memanxa

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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04

Arrow Pharma Pty Ltd

ISPE Europe

Not Confirmed

Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Memanxa

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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Corporate PDF

05

Generic Health Pty Ltd

ISPE Europe

Not Confirmed

Generic Health Pty Ltd

ISPE Europe

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Regulatory Info :

Registration Country : Australia

Brand Name : Memantine generichealth

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Generic Health Pty Ltd

ISPE Europe

Not Confirmed

Generic Health Pty Ltd

ISPE Europe

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Memantine generichealth

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Generic Health Pty Ltd

ISPE Europe

Not Confirmed

Generic Health Pty Ltd

ISPE Europe

Not Confirmed

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

Brand Name : Memantine generichealth

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Ebixa

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

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09

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

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

Brand Name : Ebixa

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

Lundbeck Australia Pty Ltd

ISPE Europe

Not Confirmed

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.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Ebixa

Dosage Form : tablet

Dosage Strength : 20 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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