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

242 API Suppliers, 80 USDMF, 21 CEP/COS, 16 JDMF, 7 EU WC, 109 KDMF, 106 NDC API, 35 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

45 Drugs in Development

45 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

2667 FDF Dossiers, 733 FDA Orange Book, 500 Europe, 289 Canada, 69 Australia, 409 South Africa, 667 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 1 Evonik, 14 Rochem International Inc, 32 SPI Pharma, 37 DKSH, 2 Pharm-RX Chemical, 11 Faran Shimi Pharmaceutical, 14 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 13 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

142 Fillers, Diluents & Binders, 85 Thickeners and Stabilizers, 72 Solubilizers, 68 Coating Systems & Additives, 60 Taste Masking, 57 Topical, 50 Disintegrants & Superdisintegrants, 50 Direct Compression, 44 Parenteral, 40 Granulation, 39 Film Formers & Plasticizers, 38 Controlled & Modified Release, 37 Lubricants & Glidants, 27 Chewable & Orodispersible Aids, 25 Emulsifying Agents, 23 Rheology Modifiers, 21 Co-Processed Excipients, 15 Surfactant & Foaming Agents, 12 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 351 News #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 403 Regulatory FDF Prices, 20 Annual Reports

MARKET PLACE

183 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 1 US Exclusivities, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 26 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

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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	Granules India Limited	India	M/s Granules India Ltd	WC-0116n	Paracetamol IP/BP/Ph. Eur	2022-06-29	2025-02-07	H.No. 6-5 & 6-11, Temple Road, Bonthapally (V), Gummadidala(M), Sangareddy(Dist.)-502313, Telangana State, India
04/06/2025	IOL Chemicals and Pharmaceuticals	India	M/s IOL Chemicals and Pharmaceuticals Ltd	WC-0004	Paracetamol IP/BP/Ph. Eur.	2025-02-27	2028-03-17	Village Fatehgarh Channa Mansa Road (Trident Complex), Barnala, District Barnala -148101, Punjab (India)

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

242 API Suppliers

80 USDMF

21 CEP/COS

16 JDMF

7 EU WC

109 KDMF

106 NDC API

35 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

45 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

2667 FDF Dossiers

733 FDA Orange Book

500 Europe

289 Canada

69 Australia

409 South Africa

667 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 325MG;37.5MG

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

TABLET;ORAL - 325MG;5MG

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

1 Evonik

14 Rochem International Inc

32 SPI Pharma

37 DKSH

2 Pharm-RX Chemical

11 Faran Shimi Pharmaceutical

14 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

4 ACG Worldwide

19 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

4 Finar

17 Gangwal Chemicals

2 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

5 Kima Chemical

6 Lonza Capsugel

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons