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

78 API Suppliers, 13 USDMF, 10 CEP/COS, 3 JDMF, 6 EU WC, 14 KDMF, 28 NDC API, 38 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

416 FDF Dossiers, 227 FDA Orange Book, 66 Europe, 63 Canada, 17 South Africa, 43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 4%, INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.005MG/ML;0.5%, INJECTABLE;INJECTION - 0.005MG/ML;1%, INJECTABLE;INJECTION - 0.005MG/ML;1.5%, INJECTABLE;INJECTION - 0.005MG/ML;2%, INJECTABLE;INJECTION - 0.01MG/ML;1%, INJECTABLE;INJECTION - 0.01MG/ML;2%, INJECTABLE;INJECTION - 0.02MG/ML;2%, INJECTABLE;INJECTION - 0.5%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 1.5%, INJECTABLE;INJECTION - 2%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 2%, INJECTABLE;INJECTION - 1%, INJECTABLE;SPINAL - 5%, JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%, INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Evonik, 6 Rochem International Inc, 12 SPI Pharma, 18 DKSH, 1 PMC Isochem, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 18 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Capital Farma, 1 ACG Worldwide, 22 Actylis, 3 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 43 BASF, 1 Bioplus Life Sciences, 1 BioSpectra, 1 Clariant, 17 Corel Pharma Chem, 3 Doshion Polyscience, 5 Finar, 13 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 18 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 9 Lubrizol Life Science Health, 9 Microlex e.U, 3 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 25 Seppic, 3 Shandong Focus Biotechnology Co., Ltd, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 2 Symrise, 3 The Dow Chemical Company, 2 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

77 Topical, 66 Solubilizers, 52 Coating Systems & Additives, 50 Thickeners and Stabilizers, 36 Fillers, Diluents & Binders, 33 Parenteral, 32 Emulsifying Agents, 32 Controlled & Modified Release, 26 Film Formers & Plasticizers, 22 Surfactant & Foaming Agents, 20 Rheology Modifiers, 18 Granulation, 18 Taste Masking, 17 Direct Compression, 14 Co-Processed Excipients, 10 API Stability Enhancers, 10 Lubricants & Glidants, 8 Chewable & Orodispersible Aids, 7 Disintegrants & Superdisintegrants, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 60 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 58 Regulatory FDF Prices

MARKET PLACE

54 APIs, 15 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

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	Apex Healthcare Limited	India	M/s Apex Healthcare limited	WC-0409	Lidocaine Hydrochloride BP/EP/USP	2024-03-01	2026-12-31	4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuch-393002, Gujarat, India
04/06/2025	Dishman Carbogen Amcis	India	M/s Dishman Carbogen Amcis Limiteds	WC-0135	Lidocaine Hydrochloride BP/Ph.Eur./USP	2022-09-30	2025-06-30	Survey No.47,48 Paiki sub Plot No.1, Village Lodariyal, Tal -Sanand, Dist -Ahmedabad-382220, Gujarat, India.

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

78 API Suppliers

13 USDMF

10 CEP/COS

3 JDMF

6 EU WC

14 KDMF

28 NDC API

38 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

416 FDF Dossiers

227 FDA Orange Book

66 Europe

63 Canada

17 South Africa

43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 4%

INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.005MG/ML;0.5%

INJECTABLE;INJECTION - 0.005MG/ML;1%

INJECTABLE;INJECTION - 0.005MG/ML;1.5%

INJECTABLE;INJECTION - 0.005MG/ML;2%

INJECTABLE;INJECTION - 0.01MG/ML;1%

INJECTABLE;INJECTION - 0.01MG/ML;2%

INJECTABLE;INJECTION - 0.02MG/ML;2%

INJECTABLE;INJECTION - 0.5%

INJECTABLE;INJECTION - 1%

INJECTABLE;INJECTION - 1.5%

INJECTABLE;INJECTION - 2%

INJECTABLE;INJECTION - 1%

INJECTABLE;INJECTION - 2%

INJECTABLE;INJECTION - 1%

INJECTABLE;SPINAL - 5%

JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%

INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Evonik

6 Rochem International Inc

12 SPI Pharma

18 DKSH

1 PMC Isochem

1 Pharm-RX Chemical

3 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

2 Gangwal Healthcare

18 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Capital Farma

1 ACG Worldwide

22 Actylis

3 Aeon Procare

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

43 BASF

1 Bioplus Life Sciences

1 BioSpectra

1 Clariant

17 Corel Pharma Chem

3 Doshion Polyscience

5 Finar

13 Gangwal Chemicals

4 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

18 Kerry

4 Kima Chemical

INJECTABLE;INJECTION - 1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 20% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

JELLY;TOPICAL - 2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons