CDMO Activity Tracker: Lupin’s CDMO commissions oncology block in India; Cambrex, Axplora, Hovione expand operations

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Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy

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Norluten

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 15 USDMF, 7 CEP/COS, 4 JDMF, 4 EU WC, 3 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

27 Drugs in Development

27 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

199 FDF Dossiers, 116 FDA Orange Book, 40 Europe, 13 Canada, 5 Australia, 17 South Africa, 8 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- 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 6 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 12 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 30 Direct Compression, 27 Granulation, 21 Controlled & Modified Release, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 15 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 10 Solubilizers, 10 Taste Masking, 8 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Parenteral

DIGITAL CONTENT

22 News #PharmaBuzz

22 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 27 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 5 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
30/12/2025	Fareva	Luxembourg	VALDEPHARM	24416	NORETHINDRONE	2011-03-07	Active	II	Complete	2014-06-05	2013-09-18
30/12/2025	Sanofi	France	ROUSSEL CORP	1920	NORETHINDRONE	1972-04-17	Inactive	II	N/A

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Norluten

Norluten

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers

15 USDMF

7 CEP/COS

4 JDMF

4 EU WC

3 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

27 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

199 FDF Dossiers

116 FDA Orange Book

40 Europe

13 Canada

5 Australia

17 South Africa

8 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

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

6 DKSH

8 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

12 BASF

11 Corel Pharma Chem

6 DFE Pharma

7 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nitika Pharmaceutical Specialities

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

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

2 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders

42 Coating Systems & Additives

30 Direct Compression

27 Granulation

TABLET;ORAL-28 - 0.35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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,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