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

Data Compilation
#PharmaFlow

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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ACTIQ

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 14 USDMF, 12 CEP/COS, 4 JDMF, 2 EU WC, 4 KDMF, 15 NDC API, 16 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

383 FDF Dossiers, 77 FDA Orange Book, 159 Europe, 24 Canada, 75 Australia, 20 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 2 DKSH, 4 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Direct Compression, 22 Controlled & Modified Release, 19 Thickeners and Stabilizers, 18 Taste Masking, 16 Chewable & Orodispersible Aids, 16 Granulation, 13 Co-Processed Excipients, 10 Lubricants & Glidants, 10 Film Formers & Plasticizers, 9 Parenteral, 6 Solubilizers, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 103 Regulatory FDF Prices

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

$ 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	Rusan Pharma	India	M/s Rusan Pharma Ltd	WC-0278	Fentanyl Citrate EP/BP/USP	2025-02-11	2027-06-09	Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
04/06/2025	Pioneer Agro Extracts	India	M/s M/s. Pioneer Agro Industries Sanvin Laboratories Private Limited	WC-0174	Fentanyl Citrate USP	2022-08-08	2024-07-08	Plot No. 6,7,8,20 & 24, MIDC Industrial Area, Post Kulgaon, Badlapur, Dist. Thane?421503, Maharashtra, India

ACTIQ

ACTIQ

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers

14 USDMF

12 CEP/COS

4 JDMF

2 EU WC

4 KDMF

15 NDC API

16 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

383 FDF Dossiers

77 FDA Orange Book

159 Europe

24 Canada

75 Australia

20 South Africa

28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE

TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

18 SPI Pharma

2 DKSH

4 Faran Shimi Pharmaceutical

2 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

6 Actylis

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 BASF

10 Corel Pharma Chem

4 DFE Pharma

1 Finar

5 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

17 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

8 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons