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

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Norethisterone Acetate
Australia

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Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

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

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

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

FINISHED DOSAGE FORMULATIONS

184 FDF Dossiers, 119 FDA Orange Book, 39 Europe, 7 Canada, 12 Australia, 7 Listed Dossiers

184 FDF Dossiers
119 FDA Orange Book
39 Europe
7 Canada
12 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- 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A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TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 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, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 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

78 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 31 Disintegrants & Superdisintegrants, 29 Direct Compression, 28 Controlled & Modified Release, 27 Granulation, 25 Solubilizers, 22 Thickeners and Stabilizers, 20 Lubricants & Glidants, 19 Co-Processed Excipients, 16 Taste Masking, 14 Parenteral, 14 Film Formers & Plasticizers, 10 Emulsifying Agents, 9 Topical, 8 Rheology Modifiers, 8 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

1 Data Compilation #PharmaFlow
47 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 40 Regulatory FDF Prices, 9 Annual Reports

2 US Medicaid Prescriptions
40 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

9 US Patents, 4 US Exclusivities

9 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

2 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 3,359 Xls

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01 4Medsurge Healthcare

02 8Sandoz B2B

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01 12Estradiol; Norethisterone Acetate

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02 8Transdermal Patch

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01 2ESTALIS 140/50 (Canada)

02 2ESTALIS 250/50 (Canada)

03 2Estalis continuous 50/140

04 2Estalis continuous 50/250

05 2Estalis sequi 50/140

06 2Estalis sequi 50/250

Coral Drugs Norethisterone Acetate

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01

Medsurge Healthcare

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : ESTALIS 140/50 (Canada)

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Medsurge Healthcare

APS Symposium

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Medsurge Healthcare

APS Symposium

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : ESTALIS 140/50 (Canada)

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Medsurge Healthcare

APS Symposium

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Medsurge Healthcare

APS Symposium

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : ESTALIS 250/50 (Canada)

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

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04

Medsurge Healthcare

APS Symposium

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Medsurge Healthcare

APS Symposium

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : ESTALIS 250/50 (Canada)

Dosage Form : Transdermal Patch

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Sandoz B2B

APS Symposium

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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 :

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Regulatory Info :

Registration Country : Australia

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06

Sandoz B2B

APS Symposium

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : Estalis sequi 50/140

Dosage Form : Sachet

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

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Registration Country : Australia

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07

Sandoz B2B

APS Symposium

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Sandoz B2B

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Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : Estalis sequi 50/250

Dosage Form : Sachet

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Sandoz B2B

APS Symposium

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Sandoz B2B

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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 :

Application Number :

Regulatory Info :

Registration Country : Australia

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Digital Content

09

Sandoz B2B

APS Symposium

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Sandoz B2B

APS Symposium

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Regulatory Info :

Registration Country : Australia

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

Product Web Link

Digital Content

10

Sandoz B2B

APS Symposium

Not Confirmed

Sandoz B2B

APS Symposium

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Estradiol; Norethisterone Acetate

Brand Name : Estalis sequi 50/250

Dosage Form : Sachet

Dosage Strength : 50MCG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Product Web Link

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