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Approved Marketing Authorisations (MA) containing Norethisterone in Europe. Original Data : EMA Website

Client Email

Product

Norethisterone
Norethisterone Acetate
Norethisterone Enanthate
Norethynodrel
Norandrostenedione
Levonorgestrel
Ethynodiol
Relugolix
Europe

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Gonane Norethisterone

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Norethisterone

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 5 EU WC, 7 NDC API, 14 Listed Suppliers, $ API Reference Price

32 API Suppliers
15 USDMF
8 CEP/COS
4 JDMF
5 EU WC
7 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

179 FDF Dossiers, 116 FDA Orange Book, 20 Europe, 13 Canada, 3 Australia, 17 South Africa, 10 Listed Dossiers

179 FDF Dossiers
116 FDA Orange Book
20 Europe
13 Canada
3 Australia
17 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

TABLET;ORAL-28 - 0.05MG;1MG
TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.35MG
TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 4 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 36 Direct Compression, 27 Controlled & Modified Release, 22 Granulation, 21 Disintegrants & Superdisintegrants, 19 Co-Processed Excipients, 17 Thickeners and Stabilizers, 16 Film Formers & Plasticizers, 16 Lubricants & Glidants, 11 Solubilizers, 10 Taste Masking, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 3 Parenteral, 2 Rheology Modifiers

81 Fillers, Diluents & Binders
46 Coating Systems & Additives
36 Direct Compression
27 Controlled & Modified Release
22 Granulation
21 Disintegrants & Superdisintegrants
19 Co-Processed Excipients
17 Thickeners and Stabilizers
16 Film Formers & Plasticizers
16 Lubricants & Glidants
11 Solubilizers
10 Taste Masking
6 Chewable & Orodispersible Aids
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
4 Coloring Agents
4 Emulsifying Agents
3 Parenteral
2 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 22 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
22 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 29 Finished Drug Prices, 1 Annual Reports

10 US Medicaid Prescriptions
29 Finished Drug Prices
1 Annual Reports

MARKET PLACE

7 APIs, 1 FDF Dossiers

7 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 2 Others

1 EDQM
2 USP
2 Others

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

Filters

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FILTER :

filter Applicant Reset all filters

20 All

01 12care4

02 1BAYER PHARMA AG

03 1Bayer (Schweiz) AG

04 1Bayer Pharma AG

05 1Campus pharma AB

06 1Dr. Kade Pharmazeuyische Fabrik GmbH

07 1Farm Agon

08 1NOVO NORDISK FARMACEUTICI SpA

09 1NOVO NORDISK SpA

10 4Novo Nordisk A/S

11 1Novo Nordisk Pharma AG

12 1Orifarm AS

13 1Pfizer AB

14 4Pfizer AS

filter Active Ingredients Reset all filters

20 All

01 1Estradiol Valerate; Norethindrone

02 1Estradiol; Estradiol; Norethisterone acetas

03 1Estradiol; Norethindrone

04 3Norethindrone

05 12Norethindrone; Conjugated Estrogens

06 1Norethisterone

07 1noretisteron

filter Dosage Form Reset all filters

20 All

01 6Antic-calc Tablet

02 6Antic-calc Tablet, Film Coated

03 1Estradiol+Norethisterone+0,51 Mg 28 Combined Oral Use

04 1Film-Coated Tablets

05 1Norethisterone 10Mg 30 Joined' Oral Use

06 1TABLETT

07 1Tabl

08 2Transdermal patches

09 1Blank

filter Country Reset all filters

20 All

01 3Italy

02 14Norway

03 1Sweden

04 2Switzerland

filter Brand Name Reset all filters

20 All

01 2Activ crazy

02 1Activelle

03 1Almina 28

04 1Cliovelle

05 1Conludag

06 2Estalis

07 1Eviana

08 1Mini-Pe

09 1Nor Prolut

10 2Novofem

11 2Primolut N

12 3Synfase

13 1Trisekvens

14 1Trisequens

Coral drugs Norethisterone

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

BAYER PHARMA AG

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BAYER PHARMA AG

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Regulatory Info :

Registration Country : Italy

Norethindrone

Brand Name : Nor Prolut

Dosage Form : Norethisterone 10Mg 30 Joined' Oral Use

Dosage Strength : 30 CPR 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Bayer Pharma AG

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Bayer Pharma AG

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Regulatory Info :

Registration Country : Norway

Norethindrone

Brand Name : Primolut N

Dosage Form : Antic-calc Tablet

Dosage Strength : 5 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

NOVO NORDISK SpA

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NOVO NORDISK SpA

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Regulatory Info :

Registration Country : Italy

Estradiol; Norethindrone

Brand Name : Activelle

Dosage Form : Estradiol+Norethisterone+0,51 Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 1 mg + 0.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

NOVO NORDISK FARMACEUTICI SpA

Luxepack

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NOVO NORDISK FARMACEUTICI SpA

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Regulatory Info :

Registration Country : Italy

Estradiol Valerate; Norethindrone

Brand Name : Trisequens

Dosage Form :

Dosage Strength : 12 Cpr + 10 Cpr + 6 Cpr

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novo Nordisk A/S

Luxepack

Not Confirmed

Novo Nordisk A/S

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Regulatory Info :

Registration Country : Norway

Norethindrone; Conjugated Estrogens

Brand Name : Activ crazy

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1MG; 0.5MG

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Pfizer AB

Luxepack

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Pfizer AB

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Regulatory Info :

Registration Country : Sweden

noretisteron

Brand Name : Mini-Pe

Dosage Form : TABLETT

Dosage Strength : 0,35 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

07

Pfizer AS

Luxepack

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Pfizer AS

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Regulatory Info :

Registration Country : Norway

Norethindrone

Brand Name : Conludag

Dosage Form : Antic-calc Tablet

Dosage Strength : 0.35 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

08

Farm Agon

Country

Luxepack

Not Confirmed

Farm Agon

Country

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Regulatory Info :

Registration Country : Norway

Norethindrone; Conjugated Estrogens

Brand Name : Activ crazy

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1MG; 0.5MG

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Campus pharma AB

Country

Luxepack

Not Confirmed

Campus pharma AB

Country

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Regulatory Info :

Registration Country : Norway

Norethindrone; Conjugated Estrogens

Brand Name : Almina 28

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100MCG; 20MCG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Dr. Kade Pharmazeuyische Fabrik GmbH

Country

Luxepack

Not Confirmed

Dr. Kade Pharmazeuyische Fabrik GmbH

Country

Luxepack

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Regulatory Info :

Registration Country : Norway

Norethindrone; Conjugated Estrogens

Brand Name : Cliovelle

Dosage Form : Antic-calc Tablet

Dosage Strength : 1MG; 0.5MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Website

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