Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

Data Compilation
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Pipeline Prospector May 2025: Pfizer strikes US$ 6 bn oncology pact; Lilly diversifies pipeline with US$ 2.3 bn in deals

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Norluten

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 5 EU WC, 3 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

182 FDF Dossiers, 116 FDA Orange Book, 20 Europe, 13 Canada, 3 Australia, 17 South Africa, 13 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- 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG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, 4 Faran Shimi Pharmaceutical, 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, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 26 Controlled & Modified Release, 24 Direct Compression, 22 Granulation, 19 Co-Processed Excipients, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 15 Lubricants & Glidants, 15 Film Formers & Plasticizers, 10 Solubilizers, 10 Taste Masking, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 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

10 US Medicaid Prescriptions, 29 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM

1 EDQM

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
04/06/2025	Symbiotec Pharmalab	India	M/s Symbiotec Pharmalab Private limited	WC-0161A2	Norethisterone BP/EP	2022-06-30	2025-07-02	385/2, Gram Pigdamber, Rau, Indore-453331, M.P., India
04/06/2025	Symbiotec Pharmalab	India	M/s Symbiotec Pharmalab Private Limited	WC-0162Amended	Norethisterone BP/EP	2022-08-31	2025-07-02	Plot No. 5,6,7 & 8, Special Economic Zone, Phase II, Pharma Zone, Pithampur, District-Dhar (M.p)-454774

Norluten

Norluten

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers

15 USDMF

8 CEP/COS

4 JDMF

5 EU WC

3 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

182 FDF Dossiers

116 FDA Orange Book

20 Europe

13 Canada

3 Australia

17 South Africa

13 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

4 Faran Shimi Pharmaceutical

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

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

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

2 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders

46 Coating Systems & Additives

26 Controlled & Modified Release

24 Direct Compression

22 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