17.alpha.-Ethynyl-19-nortestosterone | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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17.alpha.-Ethynyl-19-nortestosterone
South Africa

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17.alpha.-Ethynyl-19-nortestosterone

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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

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers, 116 FDA Orange Book, 20 Europe, 13 Canada, 3 Australia, 17 South Africa, 11 Listed Dossiers

180 FDF Dossiers
116 FDA Orange Book
20 Europe
13 Canada
3 Australia
17 South Africa
11 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- 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG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TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Lubricants & Glidants, 16 Film Formers & Plasticizers, 11 Solubilizers, 10 Taste Masking, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring 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 Lubricants & Glidants
16 Film Formers & Plasticizers
11 Solubilizers
10 Taste Masking
6 Chewable & Orodispersible Aids
5 Empty Capsules
5 API Stability Enhancers
4 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring 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) : 1,995 Xls

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01 4Adcock Ingram Limited

02 2Bayer (Pty) Ltd

03 2Janssen Pharmaceutica (Pty) Ltd

04 1Novartis South Africa (Pty) Ltd

05 5Novo Nordisk (Pty) Ltd

06 1Pfizer Laboratories (Pty) Ltd

07 2Sandoz SA (Pty) Ltd

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17 All

01 2Noresthisterone

02 15Norethisterone

filter Dosage Form Reset all filters

17 All

01 3PAD

02 2PTD

03 12TAB

filter Brand Name Reset all filters

17 All

01 1Activelle

02 2Estalis

03 1Estracombi TTS

04 1Estro-Pause N

05 1Estro-Pause N Forte

06 1Evorel Conti

07 1Evorel Sequi

08 1Kliogest

09 1Micro-Novum

10 1Norinyl 1mg

11 1Novofem

12 2Primolut N

13 1Trinovum Tablets

14 1Trisequens

15 1Trisequens Forte

Coral drugs Norethisterone

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01

Adcock Ingram Limited

2024 ACI Convention

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Adcock Ingram Limited

2024 ACI Convention

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Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Evorel Sequi

Dosage Form : PAD

Dosage Strength : 170mg/16cm

Packaging : 8X1mg/16cm^2

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Adcock Ingram Limited

2024 ACI Convention

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Adcock Ingram Limited

2024 ACI Convention

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Evorel Conti

Dosage Form : PAD

Dosage Strength : 170mg/16cm

Packaging : 8X1mg/16cm^2

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Regulatory Info : Originator

Registration Country : South Africa

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03

Adcock Ingram Limited

2024 ACI Convention

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Norethisterone

Brand Name : Estro-Pause N

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 28X1mg

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Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

2024 ACI Convention

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Adcock Ingram Limited

2024 ACI Convention

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Norethisterone

Brand Name : Estro-Pause N Forte

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 28X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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05

Bayer (Pty) Ltd

2024 ACI Convention

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Bayer (Pty) Ltd

2024 ACI Convention

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Noresthisterone

Brand Name : Primolut N

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

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Regulatory Info : Originator

Registration Country : South Africa

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06

Bayer (Pty) Ltd

2024 ACI Convention

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Bayer (Pty) Ltd

2024 ACI Convention

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Noresthisterone

Brand Name : Primolut N

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 150X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

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Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Micro-Novum

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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08

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

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Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

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Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Trinovum Tablets

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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09

Novo Nordisk (Pty) Ltd

2024 ACI Convention

Not Confirmed

Novo Nordisk (Pty) Ltd

2024 ACI Convention

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Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Novofem

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Novartis South Africa (Pty) Ltd

Country

2024 ACI Convention

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

2024 ACI Convention

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Regulatory Info : Originator

Registration Country : South Africa

Norethisterone

Brand Name : Estracombi TTS

Dosage Form : PAD

Dosage Strength : 30mg

Packaging : 8X1mg

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Regulatory Info : Originator

Registration Country : South Africa

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