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

Client Email

Product

Mirtazapine
Mirtazapine Impurity B
CAS 61338-13-4
Australia

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

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Bora Pharmaceuticals- Making success more certain.

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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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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Mirtazapine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 21 USDMF, 15 CEP/COS, 8 JDMF, 10 EU WC, 10 KDMF, 13 NDC API, 19 Listed Suppliers, $ API Reference Price

38 API Suppliers
21 USDMF
15 CEP/COS
8 JDMF
10 EU WC
10 KDMF
13 NDC API
19 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

18 API Suppliers

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

415 FDF Dossiers, 72 FDA Orange Book, 244 Europe, 34 Canada, 21 Australia, 22 South Africa, 22 Listed Dossiers

415 FDF Dossiers
72 FDA Orange Book
244 Europe
34 Canada
21 Australia
22 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 15MG, TABLET;ORAL - 30MG, TABLET;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 15MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG, TABLET, ORALLY DISINTEGRATING;ORAL - 45MG

TABLET;ORAL - 15MG
TABLET;ORAL - 30MG
TABLET;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 15MG
TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
TABLET, ORALLY DISINTEGRATING;ORAL - 45MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 4 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 4 DKSH, 3 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 49 Direct Compression, 37 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 30 Granulation, 29 Thickeners and Stabilizers, 27 Taste Masking, 27 Solubilizers, 22 Chewable & Orodispersible Aids, 21 Lubricants & Glidants, 21 Co-Processed Excipients, 16 Parenteral, 15 Film Formers & Plasticizers, 14 Topical, 8 API Stability Enhancers, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

96 Fillers, Diluents & Binders
51 Coating Systems & Additives
49 Direct Compression
37 Disintegrants & Superdisintegrants
30 Controlled & Modified Release
30 Granulation
29 Thickeners and Stabilizers
27 Taste Masking
27 Solubilizers
22 Chewable & Orodispersible Aids
21 Lubricants & Glidants
21 Co-Processed Excipients
16 Parenteral
15 Film Formers & Plasticizers
14 Topical
8 API Stability Enhancers
7 Emulsifying Agents
5 Rheology Modifiers
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 226 Finished Drug Prices, 2 Annual Reports

2 US Medicaid Prescriptions
226 Finished Drug Prices
2 Annual Reports

MARKET PLACE

13 APIs, 2 FDF Dossiers

13 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 7 Others

2 EDQM
4 USP
7 Others

$ API Ref.Price (USD/KG) : 362 Xls

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21 All

01 4Alphapharm Pty Ltd

02 3Apotex Pty Ltd

03 6Arrow Pharma Pty Ltd

04 2Avallon Pharmaceuticals Pty Limited

05 6Sandoz Pty Ltd

filter Active Ingredients Reset all filters

21 All

01 21mirtazapine

filter Dosage Form Reset all filters

21 All

01 18tablet

02 3Blank

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21 All

01 3APX-Mirtazapine

02 1Avanza

03 1Axit 15

04 1Axit 30

05 1Axit 45

06 3Blooms The Chemist Mirtazapine

07 3MIRTANZA

08 3MIRTANZA ODT

09 3Mirtazapine Sandoz

10 2NOUMED MIRTAZAPINE

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

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01

Alphapharm Pty Ltd

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Not Confirmed

Alphapharm Pty Ltd

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Not Confirmed

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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : Axit 30

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Alphapharm Pty Ltd

Discovery on Target

Not Confirmed

Alphapharm Pty Ltd

Discovery on Target

Not Confirmed

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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : Avanza

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Apotex Pty Ltd

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Apotex Pty Ltd

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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : APX-Mirtazapine

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Arrow Pharma Pty Ltd

Discovery on Target

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Arrow Pharma Pty Ltd

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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : MIRTANZA

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Arrow Pharma Pty Ltd

Discovery on Target

Not Confirmed

Arrow Pharma Pty Ltd

Discovery on Target

Not Confirmed

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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : MIRTANZA ODT

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Arrow Pharma Pty Ltd

Discovery on Target

Not Confirmed

Arrow Pharma Pty Ltd

Discovery on Target

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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Regulatory Info :

Registration Country : Australia

mirtazapine

Brand Name : MIRTANZA ODT

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Arrow Pharma Pty Ltd

Discovery on Target

Not Confirmed

Arrow Pharma Pty Ltd

Discovery on Target

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

mirtazapine

Brand Name : MIRTANZA ODT

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Avallon Pharmaceuticals Pty Limited

Discovery on Target

Not Confirmed

Avallon Pharmaceuticals Pty Limited

Discovery on Target

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

mirtazapine

Brand Name : NOUMED MIRTAZAPINE

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Sandoz Pty Ltd

Discovery on Target

Not Confirmed

Sandoz Pty Ltd

Discovery on Target

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

mirtazapine

Brand Name : Blooms The Chemist Mirtazapine

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Product Web Link

Digital Content

10

Sandoz Pty Ltd

Discovery on Target

Not Confirmed

Sandoz Pty Ltd

Discovery on Target

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

mirtazapine

Brand Name : Mirtazapine Sandoz

Dosage Form : tablet

Dosage Strength : 30 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Product Web Link

Digital Content

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