LYBREL-1 | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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LYBREL-1
Australia

Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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Topscience Biotech specializes in R&D, production, sales of Sodium Hyaluronate, focusing on Cosmetics, Medical, Pharmaceutical Grade HA

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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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AMI Lifesciences is Driven by Chemistry. Powered by People.

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China

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LYBREL-1

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 29 USDMF, 11 CEP/COS, 3 JDMF, 6 EU WC, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

53 API Suppliers
29 USDMF
11 CEP/COS
3 JDMF
6 EU WC
20 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 136 FDA Orange Book, 80 Europe, 30 Canada, 7 Australia, 30 South Africa, 29 Listed Dossiers

312 FDF Dossiers
136 FDA Orange Book
80 Europe
30 Canada
7 Australia
30 South Africa
29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, SYSTEM;INTRAUTERINE - 52MG, TABLET;ORAL - 0.02MG;0.1MG, SYSTEM;INTRAUTERINE - 52MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 1.5MG

TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
SYSTEM;INTRAUTERINE - 52MG
TABLET;ORAL - 0.02MG;0.1MG
SYSTEM;INTRAUTERINE - 52MG
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
TABLET;ORAL - 1.5MG

RELATED EXCIPIENT COMPANIES

5 SPI Pharma, 10 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 11 Corel Pharma Chem, 5 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 17 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 27 Controlled & Modified Release, 23 Thickeners and Stabilizers, 22 Disintegrants & Superdisintegrants, 21 Direct Compression, 20 Granulation, 16 Co-Processed Excipients, 13 Solubilizers, 13 Lubricants & Glidants, 10 Taste Masking, 9 Empty Capsules, 8 Film Formers & Plasticizers, 7 Topical, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 4 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Parenteral

65 Fillers, Diluents & Binders
44 Coating Systems & Additives
27 Controlled & Modified Release
23 Thickeners and Stabilizers
22 Disintegrants & Superdisintegrants
21 Direct Compression
20 Granulation
16 Co-Processed Excipients
13 Solubilizers
13 Lubricants & Glidants
10 Taste Masking
9 Empty Capsules
8 Film Formers & Plasticizers
7 Topical
6 Rheology Modifiers
6 Chewable & Orodispersible Aids
5 API Stability Enhancers
4 Coloring Agents
4 Emulsifying Agents
4 Vegetarian Capsules
3 Parenteral

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 79 News #PharmaBuzz

1 Data Compilation #PharmaFlow
79 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 67 Regulatory FDF Prices, 14 Annual Reports

6 US Medicaid Prescriptions
67 Regulatory FDF Prices
14 Annual Reports

MARKET PLACE

8 APIs, 5 FDF Dossiers

8 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 US Patents, 2 US Exclusivities

20 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

5 EDQM, 1 JP, 7 Others

5 EDQM
1 JP
7 Others

$ API Ref.Price (USD/KG) : 7,051 Xls

Filters

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FILTER :

filter Applicant Reset all filters

7 All

01 2AFT Pharmaceuticals

02 4Bayer Australia Ltd

03 1WAGNER PHARMACEUTICALS PTY LTD

filter Active Ingredients Reset all filters

7 All

01 4Levonorgestrel

02 3Levonorgestrel; Ethinylestradiol

filter Dosage Form Reset all filters

7 All

01 3Tablet

02 4Blank

filter Brand Name Reset all filters

7 All

01 1Femme-Tab ED 20/100

02 1Femme-Tab ED 30/150

03 1Kyleena

04 1LEVETH 150/30 ED

05 1Microlut 28

06 2Mirena

List of Suppliers

Product Main Page

01

AFT Pharmaceuticals

IMCAS Asia

Not Confirmed

AFT Pharmaceuticals

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Levonorgestrel; Ethinylestradiol

Brand Name : Femme-Tab ED 30/150

Dosage Form : Tablet

Dosage Strength : 150MCG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

AFT Pharmaceuticals

IMCAS Asia

Not Confirmed

AFT Pharmaceuticals

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Levonorgestrel; Ethinylestradiol

Brand Name : Femme-Tab ED 20/100

Dosage Form : Tablet

Dosage Strength : 100MCG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Levonorgestrel

Brand Name : Kyleena

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Levonorgestrel

Brand Name : Mirena

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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Digital Content

Corporate PDF

05

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Levonorgestrel

Brand Name : Microlut 28

Dosage Form :

Dosage Strength :

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

Bayer Australia Ltd

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Levonorgestrel

Brand Name : Mirena

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

WAGNER PHARMACEUTICALS PTY LTD

Country

IMCAS Asia

Not Confirmed

WAGNER PHARMACEUTICALS PTY LTD

Country

IMCAS Asia

Not Confirmed

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Virtual Booth

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Regulatory Info :

Registration Country : Australia

Levonorgestrel; Ethinylestradiol

Brand Name : LEVETH 150/30 ED

Dosage Form : Tablet

Dosage Strength : 150MCG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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