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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Aspicam

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ACTIVE PHARMA INGREDIENTS

88 API Suppliers, 22 USDMF, 16 CEP/COS, 8 JDMF, 16 EU WC, 29 KDMF, 20 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

50 Drugs in Development

50 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

333 FDF Dossiers, 63 FDA Orange Book, 69 Europe, 36 Canada, 34 Australia, 44 South Africa, 87 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 15MG, TABLET;ORAL - 7.5MG, SOLUTION;INTRAVENOUS - 30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 7.5MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 8 SPI Pharma, 11 DKSH, 6 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 4 ACG Worldwide, 7 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 20 BASF, 7 DFE Pharma, 7 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 27 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders, 40 Disintegrants & Superdisintegrants, 30 Direct Compression, 26 Granulation, 23 Thickeners and Stabilizers, 19 Lubricants & Glidants, 16 Coating Systems & Additives, 16 Taste Masking, 14 Co-Processed Excipients, 13 Chewable & Orodispersible Aids, 12 Controlled & Modified Release, 12 Film Formers & Plasticizers, 10 Solubilizers, 9 Parenteral, 8 Empty Capsules, 7 Topical, 5 Rheology Modifiers, 4 Emulsifying Agents, 3 API Stability Enhancers, 2 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 49 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

35 APIs, 2 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

80 US Patents, 4 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 6 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
04/06/2025	Apex Healthcare Limited	India	APEX HEALTHCARE LTD	39911	MELOXICAM USP	2024-05-06	Active	II	N/A
04/06/2025	Alkermes Plc	Ireland	ALKERMES INC	18805	MELOXICAM NANOCRYSTAL® TABLETS	2005-09-26	Inactive	II	N/A

Aspicam

Aspicam

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

88 API Suppliers

22 USDMF

16 CEP/COS

8 JDMF

16 EU WC

29 KDMF

20 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

50 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

333 FDF Dossiers

63 FDA Orange Book

69 Europe

36 Canada

34 Australia

44 South Africa

87 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 15MG

TABLET;ORAL - 7.5MG

SOLUTION;INTRAVENOUS - 30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

SUSPENSION;ORAL - 7.5MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

8 SPI Pharma

11 DKSH

6 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

4 ACG Worldwide

7 Actylis

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

20 BASF

7 DFE Pharma

7 Gangwal Chemicals

2 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

26 Kerry

3 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Novo Excipients

5 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qualicaps

27 Roquette

1 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

4 Silverline Chemicals

2 Ulanqab Kema New Material

4 Vasa Pharmachem

2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders

40 Disintegrants & Superdisintegrants

30 Direct Compression

26 Granulation

SOLUTION;INTRAVENOUS - 30MG/ML (30MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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