CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

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Pipeline Prospector September 2025: Genmab buys Merus for ~US$ 8 billion, Pfizer buys Metsera to enter obesity race

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 7 USDMF, 5 CEP/COS, 1 JDMF, 2 EU WC, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers, 61 FDA Orange Book, 35 Europe, 3 Canada, 1 Australia, 59 South Africa, 17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 50MG;300MG;120MG, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 50MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 12 SPI Pharma, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 4 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 17 BASF, 1 CD Formulation, 7 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 4 Ingredion Pharma Solutions, 14 Kerry, 4 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 18 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 27 Roquette, 2 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 6 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 34 Thickeners and Stabilizers, 30 Direct Compression, 28 Granulation, 27 Disintegrants & Superdisintegrants, 23 Lubricants & Glidants, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 15 Co-Processed Excipients, 14 Parenteral, 14 Taste Masking, 13 Solubilizers, 9 Chewable & Orodispersible Aids, 9 Controlled & Modified Release, 8 Empty Capsules, 8 Topical, 7 Rheology Modifiers, 7 Emulsifying Agents, 3 API Stability Enhancers, 3 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 15 Regulatory FDF Prices

MARKET PLACE

12 APIs, 5 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 3 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

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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
27/09/2025	Bayer AG	Germany	BAYER CORP	5890	ISONIAZID (NEOTEBEN)	1985-06-21	Inactive	II	N/A
27/09/2025	Bristol Myers Squibb	U.S.A	ER SQUIBB AND SONS INC	89	NYDRAZID	1979-04-04	Inactive	II	N/A

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers

7 USDMF

5 CEP/COS

1 JDMF

2 EU WC

7 NDC API

5 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers

61 FDA Orange Book

35 Europe

3 Canada

1 Australia

59 South Africa

17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 50MG;300MG;120MG

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SYRUP;ORAL - 50MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI

3 Rochem International Inc

12 SPI Pharma

12 DKSH

4 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

4 ACG Worldwide

4 Actylis

2 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

17 BASF

1 CD Formulation

7 DFE Pharma

1 Finar

7 Gangwal Chemicals

1 Ideal Cures

4 Ingredion Pharma Solutions

14 Kerry

4 Keval Exports

1 Kima Chemical

3 Lonza Capsugel

18 Microlex e.U

2 Nitika Pharmaceutical Specialities

1 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qualicaps

27 Roquette

2 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

5 Silverline Chemicals

1 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

6 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders

34 Thickeners and Stabilizers

30 Direct Compression

28 Granulation

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons