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Australian Register of Therapeutic Goods list of Approved Drug Products containing MolPort-001-728-041. Original Data : Therapeutic Goods Administration Website

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Product

MolPort-001-728-041
Australia

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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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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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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MolPort-001-728-041

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 9 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 8 NDC API, 13 Listed Suppliers, $ API Reference Price

25 API Suppliers
15 USDMF
9 CEP/COS
1 JDMF
5 EU WC
3 KDMF
8 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

198 FDF Dossiers, 55 FDA Orange Book, 60 Europe, 12 Canada, 36 Australia, 9 South Africa, 26 Listed Dossiers

198 FDF Dossiers
55 FDA Orange Book
60 Europe
12 Canada
36 Australia
9 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, SUSPENSION;ORAL - 50MG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG
TABLET;ORAL - 200MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
SUSPENSION;ORAL - 50MG/ML
TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 28 Kerry, 13 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 41 Direct Compression, 24 Disintegrants & Superdisintegrants, 24 Taste Masking, 23 Lubricants & Glidants, 22 Granulation, 21 Thickeners and Stabilizers, 21 Co-Processed Excipients, 20 Chewable & Orodispersible Aids, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 14 Controlled & Modified Release, 12 Parenteral, 8 Solubilizers, 5 API Stability Enhancers, 5 Topical, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

88 Fillers, Diluents & Binders
41 Direct Compression
24 Disintegrants & Superdisintegrants
24 Taste Masking
23 Lubricants & Glidants
22 Granulation
21 Thickeners and Stabilizers
21 Co-Processed Excipients
20 Chewable & Orodispersible Aids
17 Coating Systems & Additives
16 Film Formers & Plasticizers
14 Controlled & Modified Release
12 Parenteral
8 Solubilizers
5 API Stability Enhancers
5 Topical
3 Rheology Modifiers
3 Emulsifying Agents
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Finished Drug Prices

3 US Medicaid Prescriptions
57 Finished Drug Prices

MARKET PLACE

5 APIs, 7 FDF Dossiers, 1 Intermediates

5 APIs
7 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 7 Others

2 EDQM
2 USP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 198 Xls

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01 12Juno Pharmaceuticals Pty Ltd

02 18Pfizer Australia Pty Ltd

03 6Viatris Pty Ltd

filter Active Ingredients Reset all filters

36 All

01 36clozapine

filter Dosage Form Reset all filters

36 All

01 6oral

02 30tablet

filter Brand Name Reset all filters

36 All

01 3Clopine 100

02 3Clopine 200

03 3Clopine 25

04 3Clopine 50

05 3Clopine Suspension

06 3Clozaril 100

07 3Clozaril 25

08 12Clozitor

09 3Versacloz

FDF Dossiers
FDA Orange Book
Europe
Canada
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South Africa
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01

Juno Pharmaceuticals Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clozitor

Dosage Form : tablet

Dosage Strength : 200 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Juno Pharmaceuticals Pty Ltd

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Juno Pharmaceuticals Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clozitor

Dosage Form : tablet

Dosage Strength : 25 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Juno Pharmaceuticals Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clozitor

Dosage Form : tablet

Dosage Strength : 50 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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04

Juno Pharmaceuticals Pty Ltd

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Juno Pharmaceuticals Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clozitor

Dosage Form : tablet

Dosage Strength : 100 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Product Web Link

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05

Pfizer Australia Pty Ltd

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Pfizer Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clopine 200

Dosage Form : tablet

Dosage Strength : 200 mg

Packaging : 100

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Application Number :

Regulatory Info :

Registration Country : Australia

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Pfizer Australia Pty Ltd

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Pfizer Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clopine 25

Dosage Form : tablet

Dosage Strength : 25 mg

Packaging : 100

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Pfizer Australia Pty Ltd

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Pfizer Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clopine 50

Dosage Form : tablet

Dosage Strength : 50 mg

Packaging : 100

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Application Number :

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Registration Country : Australia

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08

Pfizer Australia Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clopine Suspension

Dosage Form : oral

Dosage Strength : 50 mg/mL

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Viatris Pty Ltd

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Viatris Pty Ltd

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Clozaril 25

Dosage Form : tablet

Dosage Strength : 25 mg

Packaging : 100

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Application Number :

Regulatory Info :

Registration Country : Australia

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10

Viatris Pty Ltd

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Viatris Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Clozaril 100

Dosage Form : tablet

Dosage Strength : 100 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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