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

23 API Suppliers, 7 USDMF, 4 CEP/COS, 2 JDMF, 4 EU WC, 9 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

362 FDF Dossiers, 129 FDA Orange Book, 129 Europe, 15 Canada, 31 Australia, 18 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG, GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 2.5MG/0.5ML (5MG/ML), GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 3 DKSH, 5 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 26 Disintegrants & Superdisintegrants, 25 Controlled & Modified Release, 21 Direct Compression, 21 Thickeners and Stabilizers, 19 Granulation, 18 Lubricants & Glidants, 18 Film Formers & Plasticizers, 16 Topical, 13 Taste Masking, 11 Co-Processed Excipients, 9 Solubilizers, 8 Chewable & Orodispersible Aids, 7 Parenteral, 6 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 72 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 136 Regulatory FDF Prices, 3 Annual Reports

MARKET PLACE

31 APIs, 24 FDF Dossiers

PATENTS & EXCLUSIVITIES

24 US Patents, 6 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 10 Others

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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	Rusan Pharma	India	M/s Rusan Pharma Ltd	WC-0278	Diazepam EP	2025-02-11	2027-06-09	Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
04/06/2025	Centaur Pharmaceuticals	India	M/s Centaur Pharmaceuticals Pvt Ltd	WC-0107	Diazepam IP/BP/EP/USP	2022-06-08	2025-06-25	Plot No. 75/76, 76/1 & 74, Chikhloli MIDC, Ambernath (West), Thane- 421501, Maharashtra State India

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers

7 USDMF

4 CEP/COS

2 JDMF

4 EU WC

9 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

34 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

362 FDF Dossiers

129 FDA Orange Book

129 Europe

15 Canada

31 Australia

18 South Africa

40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 2MG

TABLET;ORAL - 5MG

GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 2.5MG/0.5ML (5MG/ML)

GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

3 DKSH

5 Faran Shimi Pharmaceutical

6 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 ACG Worldwide

4 Actylis

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

2 Clariant

10 Corel Pharma Chem

7 DFE Pharma

3 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

27 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

5 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

5 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders

47 Coating Systems & Additives

26 Disintegrants & Superdisintegrants

25 Controlled & Modified Release

GEL;RECTAL - 10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons