DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

Data Compilation
#PharmaFlow

Pipeline Prospector April 2025: Merck KGaA buys SpringWorks for US$ 3.9 bn; Swiss giants lead pharma migration to US soil

Stock Recap
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Armex

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ACTIVE PHARMA INGREDIENTS

87 API Suppliers, 22 USDMF, 16 CEP/COS, 8 JDMF, 14 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

332 FDF Dossiers, 62 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- 7.5MG, SOLUTION;INTRAVENOUS - 30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 7.5MG/5ML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, 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, 18 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

79 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
25/04/2025	Apex Healthcare	India	APEX HEALTHCARE LTD	39911	MELOXICAM USP	2024-05-06	Active	II	N/A
25/04/2025	Alkermes Plc	Ireland	ALKERMES INC	18805	MELOXICAM NANOCRYSTAL® TABLETS	2005-09-26	Inactive	II	N/A

Armex

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

87 API Suppliers

22 USDMF

16 CEP/COS

8 JDMF

14 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

332 FDF Dossiers

62 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

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

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