Norethisterone Acetate | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Norethisterone Acetate
Australia

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pharmacompass-2-m-2025-11-03

Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 1 EU WC, 5 NDC API, 13 Listed Suppliers, $ API Reference Price

25 API Suppliers
12 USDMF
4 CEP/COS
2 JDMF
1 EU WC
5 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

56 Drugs in Development

56 Drugs in Development

FINISHED DOSAGE FORMULATIONS

239 FDF Dossiers, 120 FDA Orange Book, 96 Europe, 7 Canada, 9 Australia, 7 Listed Dossiers

239 FDF Dossiers
120 FDA Orange Book
96 Europe
7 Canada
9 Australia
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

TABLET;ORAL-28 - 0.02MG;1MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
CAPSULE;ORAL - 0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG;0.5MG
TABLET;ORAL - 0.0025MG;0.5MG
TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 35 Direct Compression, 32 Granulation, 31 Disintegrants & Superdisintegrants, 25 Solubilizers, 23 Thickeners and Stabilizers, 23 Controlled & Modified Release, 20 Lubricants & Glidants, 16 Taste Masking, 15 Parenteral, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 10 Emulsifying Agents, 9 Topical, 8 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

64 Fillers, Diluents & Binders
51 Coating Systems & Additives
35 Direct Compression
32 Granulation
31 Disintegrants & Superdisintegrants
25 Solubilizers
23 Thickeners and Stabilizers
23 Controlled & Modified Release
20 Lubricants & Glidants
16 Taste Masking
15 Parenteral
14 Film Formers & Plasticizers
13 Co-Processed Excipients
10 Emulsifying Agents
9 Topical
8 Rheology Modifiers
8 Chewable & Orodispersible Aids
8 API Stability Enhancers
6 Surfactant & Foaming Agents
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

1 Data Compilation #PharmaFlow
47 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 30 Regulatory FDF Prices, 7 Annual Reports

13 US Medicaid Prescriptions
30 Regulatory FDF Prices
7 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

10 US Patents, 4 US Exclusivities, 1 Health Canada Patents

10 US Patents
4 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

2 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 1,173 Xls

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01 1Gedeon Richter Australia Pty Ltd

02 8Sandoz Pty Ltd

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01 4estradiol (&) estradiol + norethisterone acetate

02 4estradiol + norethisterone acetate

03 1relugolix + estradiol + norethisterone acetate

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01 4Sachet

02 4Transdermal Patch

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01 2Estalis continuous 50/140

02 2Estalis continuous 50/250

03 2Estalis sequi 50/140

04 2Estalis sequi 50/250

05 1Ryeqo

Coral Drugs Norethisterone Acetate

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Gedeon Richter Australia Pty Ltd

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Gedeon Richter Australia Pty Ltd

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relugolix + estradiol + norethisterone acetate

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Sandoz Pty Ltd

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estradiol + norethisterone acetate

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Sandoz Pty Ltd

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estradiol (&) estradiol + norethisterone acetate

Brand Name : Estalis sequi 50/140

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Sandoz Pty Ltd

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estradiol (&) estradiol + norethisterone acetate

Brand Name : Estalis sequi 50/250

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Dosage Strength : 50MCG

Packaging : 1

Approval Date :

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Registration Country : Australia

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

estradiol + norethisterone acetate

Brand Name : Estalis continuous 50/250

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

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Regulatory Info :

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

estradiol (&) estradiol + norethisterone acetate

Brand Name : Estalis sequi 50/140

Dosage Form : Sachet

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Sandoz Pty Ltd

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Registration Country : Australia

estradiol (&) estradiol + norethisterone acetate

Brand Name : Estalis sequi 50/250

Dosage Form : Sachet

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

estradiol + norethisterone acetate

Brand Name : Estalis continuous 50/140

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Sandoz Pty Ltd

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Regulatory Info :

Registration Country : Australia

estradiol + norethisterone acetate

Brand Name : Estalis continuous 50/250

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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