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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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 16 USDMF, 13 CEP/COS, 1 JDMF, 3 EU WC, 15 KDMF, 11 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

FINISHED DOSAGE FORMULATIONS

409 FDF Dossiers, 118 FDA Orange Book, 87 Europe, 18 Canada, 14 Australia, 50 South Africa, 122 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/100ML, INJECTABLE;INJECTION - 500MG/100ML, GEL;TOPICAL - 0.75%, GEL;VAGINAL - 0.75%, GEL;VAGINAL - 1.3%, CREAM;TOPICAL - 0.75%, SUSPENSION;ORAL - 500MG/5ML, GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 6 SPI Pharma, 13 DKSH, 4 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 29 BASF, 1 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Lubrizol Life Science Health, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 32 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 45 Thickeners and Stabilizers, 39 Solubilizers, 34 Topical, 34 Controlled & Modified Release, 32 Direct Compression, 31 Disintegrants & Superdisintegrants, 27 Granulation, 23 Film Formers & Plasticizers, 20 Parenteral, 19 Lubricants & Glidants, 17 Taste Masking, 14 Co-Processed Excipients, 11 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 83 Regulatory FDF Prices

MARKET PLACE

75 APIs, 40 FDF Dossiers

PATENTS & EXCLUSIVITIES

11 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 10 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ 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	Aarti Drugs	India	M/s Aarti Drugs Ltd	WC-0377	Metronidazole BP/EP/USP	2024-05-20	2027-01-11	Plot No.2902-2904, 2601 to 2605, 2509, G.I.D.C., At & Post, - Sarigam, Dist -Valsad
04/06/2025	Unichem Laboratories Limited	India	M/s Unichem Laboratories Limited	WC-0468	Metronidazole Ph. Eur	2023-05-22	2026-03-30	Plot No. T-47, Five Star MIDC, Kagal, Hatkanangale, Dist. Kolhapur, Pin-416236, Maharashtra, India

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers

16 USDMF

13 CEP/COS

1 JDMF

3 EU WC

15 KDMF

11 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

FINISHED DOSAGE FORMULATIONS

409 FDF Dossiers

118 FDA Orange Book

87 Europe

18 Canada

14 Australia

50 South Africa

122 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 500MG/100ML

INJECTABLE;INJECTION - 500MG/100ML

GEL;TOPICAL - 0.75%

GEL;VAGINAL - 0.75%

GEL;VAGINAL - 1.3%

CREAM;TOPICAL - 0.75%

SUSPENSION;ORAL - 500MG/5ML

GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

6 SPI Pharma

13 DKSH

4 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

4 ACG Worldwide

12 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

29 BASF

1 Clariant

17 Corel Pharma Chem

6 DFE Pharma

3 Finar

11 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

37 Kerry

3 Kima Chemical

6 Lonza Capsugel

8 Lubrizol Life Science Health

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

32 Roquette

14 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons