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Approved Marketing Authorisations (MA) containing 19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha) in Europe. Original Data : EMA Website

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Product

19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)
Europe

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Gonane Norethisterone acetate

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xyz-pharma-m-2024-10-07

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 6 NDC API, 12 Listed Suppliers, $ API Reference Price

22 API Suppliers
12 USDMF
4 CEP/COS
2 JDMF
3 EU WC
6 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

FINISHED DOSAGE FORMULATIONS

168 FDF Dossiers, 119 FDA Orange Book, 39 Europe, 7 Canada, 3 Listed Dossiers

168 FDF Dossiers
119 FDA Orange Book
39 Europe
7 Canada
3 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- 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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

2 Rochem International Inc, 5 SPI Pharma, 4 DKSH, 2 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 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, 7 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, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 34 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 27 Granulation, 26 Solubilizers, 23 Thickeners and Stabilizers, 21 Lubricants & Glidants, 19 Co-Processed Excipients, 17 Taste Masking, 16 Film Formers & Plasticizers, 14 Parenteral, 10 Emulsifying Agents, 9 Topical, 8 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

85 Fillers, Diluents & Binders
56 Coating Systems & Additives
41 Direct Compression
34 Disintegrants & Superdisintegrants
29 Controlled & Modified Release
27 Granulation
26 Solubilizers
23 Thickeners and Stabilizers
21 Lubricants & Glidants
19 Co-Processed Excipients
17 Taste Masking
16 Film Formers & Plasticizers
14 Parenteral
10 Emulsifying Agents
9 Topical
8 API Stability Enhancers
7 Chewable & Orodispersible Aids
6 Rheology Modifiers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 47 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 40 Finished Drug Prices, 9 Annual Reports

2 US Medicaid Prescriptions
40 Finished Drug 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, 3 Others

2 EDQM
1 USP
3 Others

$ API Ref.Price (USD/KG) : 7,465 Xls

Filters

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filter Applicant Reset all filters

39 All

01 12care4 ApS

02 1Bayer Pharma AG

03 1Dr. Kade Pharmazeuyische Fabrik GmbH

04 3Future Health Pharma GmbH

05 2Gedeon Richter Plc

06 2Gedeon Richter Plc.

07 10Medical Valley Invest AB

08 1NOVO NORDISK FARMACEUTICI SpA

09 4Novo Nordisk A/S

10 3Novo Nordisk Pharma AG

11 4Orifarm AS

12 1Sandoz - K?benhavn

13 2Sandoz A/S

14 4Sandoz Pharmaceuticals AG

filter Active Ingredients Reset all filters

39 All

01 9Estradiol hemihydrate, Norethisterone acetate

02 1Estradiol valerate, Norethisterone acetate

03 1Estradiol; Norethindrone Acetate

04 6Estradiol; Norethisterone acetate

05 3Estradiolum hemihydricum; Norethisteroni acetas

06 1Estradiolum; Norethisteroni acetas

07 7Relugolix, Estradiol hemihydrate, Norethisterone acetate

08 10Tapentadultartrat

09 1norethisterone acetate

filter Dosage Form Reset all filters

39 All

01 3Depot patch

02 10Depot tablet

03 2Film-Coated Tablets

04 1Filmtabl

05 7Matrixpfl

06 1TABLET

07 1Tablet

08 13Tablet, film-coated

09 1Blank

filter Country Reset all filters

39 All

01 1Italy

02 27Norway

03 1Sweden

04 10Switzerland

filter Brand Name Reset all filters

39 All

01 4 Ryeqo

02 3Activelle

03 1Cliovelle

04 6Estalis

05 1Eviana

06 1Kliogest

07 1Kliogest N

08 1Noresmea

09 1Novofem

10 1Primolut-Nor

11 3Ryeqo

12 1Sequidot

13 2Systen Conti

14 1Systen Sequi

15 10Tapentadol Medical Valley

16 1Trisequence

17 1Trisequens N

Coral Drugs Norethisterone Acetate

FDF Dossiers
FDA Orange Book
Europe
Canada
Listed Dossiers

List of Suppliers

Product Main Page

01

Bayer Pharma AG

AAPS 2024

Not Confirmed

Bayer Pharma AG

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Sweden

norethisterone acetate

Brand Name : Primolut-Nor

Dosage Form : TABLET

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

NOVO NORDISK FARMACEUTICI SpA

AAPS 2024

Not Confirmed

NOVO NORDISK FARMACEUTICI SpA

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Italy

Estradiol; Norethindrone Acetate

Brand Name : Kliogest

Dosage Form :

Dosage Strength : 28 Cpr 2 Mg + 1 Mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Novo Nordisk A/S

AAPS 2024

Not Confirmed

Novo Nordisk A/S

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Novofem

Dosage Form : Tablet, film-coated

Dosage Strength : 1mg/1mg

Packaging : Blisterpakning 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Novo Nordisk A/S

AAPS 2024

Not Confirmed

Novo Nordisk A/S

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Eviana

Dosage Form : Tablet, film-coated

Dosage Strength : 0.5mg/0.1mg

Packaging : Blisterpakning 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novo Nordisk A/S

AAPS 2024

Not Confirmed

Novo Nordisk A/S

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Trisequence

Dosage Form : Tablet, film-coated

Dosage Strength :

Packaging : Blisterpakning 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novo Nordisk A/S

AAPS 2024

Not Confirmed

Novo Nordisk A/S

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Activelle

Dosage Form : Tablet, film-coated

Dosage Strength : 1mg/0.5mg

Packaging : Blisterpakning 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Orifarm AS

AAPS 2024

Not Confirmed

Orifarm AS

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Estalis

Dosage Form : Depot patch

Dosage Strength : 50 microg/250 microg/24 hours

Packaging : Foliepose 24item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Orifarm AS

AAPS 2024

Not Confirmed

Orifarm AS

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Activelle

Dosage Form : Tablet, film-coated

Dosage Strength : 1mg/0.5mg

Packaging : Calendar packaging 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Sandoz - K?benhavn

AAPS 2024

Not Confirmed

Sandoz - K?benhavn

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Noresmea

Dosage Form : Tablet, film-coated

Dosage Strength : 1mg/0.5mg

Packaging : Blisterpakning 3 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Product Web Link

Digital Content

10

Sandoz A/S

AAPS 2024

Not Confirmed

Sandoz A/S

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Estradiol hemihydrate, Norethisterone acetate

Brand Name : Sequidot

Dosage Form : Depot patch

Dosage Strength : 50 microg/250 microg

Packaging : Foliepose 24 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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