CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

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Pipeline Prospector March 2025: Trump’s FDA overhaul spooks biotech stocks; Roche, AbbVie, Novo ink obesity drug deals

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 16 USDMF, 9 CEP/COS, 1 JDMF, 3 EU WC, 14 KDMF, 5 NDC API, 10 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem, 5 SPI Pharma, 5 DKSH, 3 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 28 Solubilizers, 28 Controlled & Modified Release, 25 Thickeners and Stabilizers, 23 Direct Compression, 19 Granulation, 18 Topical, 16 Film Formers & Plasticizers, 13 Co-Processed Excipients, 11 Disintegrants & Superdisintegrants, 11 Parenteral, 11 Lubricants & Glidants, 9 Emulsifying Agents, 7 API Stability Enhancers, 7 Taste Masking, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents

DIGITAL CONTENT

6 News #PharmaBuzz

6 News #PharmaBuzz

GLOBAL SALES INFORMATION

75 Regulatory FDF Prices, 3 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical 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
28/03/2025	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	25373	FELODIPINE USP	2011-10-11	Active	II	Complete	2014-06-03	2013-09-27
28/03/2025	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	20890	FELODIPINE USP, NON-STERILE DRUG SUBSTANCE	2007-09-24	Active	II	N/A

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers

16 USDMF

9 CEP/COS

1 JDMF

3 EU WC

14 KDMF

5 NDC API

10 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers

44 FDA Orange Book

96 Europe

8 Canada

22 Australia

7 South Africa

27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem

5 SPI Pharma

5 DKSH

3 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

4 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pramukh Pharmachem

1 Zeal MediPharma

1 ACG Worldwide

5 Actylis

3 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

21 BASF

1 Clariant

11 Corel Pharma Chem

5 DFE Pharma

2 Finar

11 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

7 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

3 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

15 Roquette

14 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

2 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders

46 Coating Systems & Additives

28 Solubilizers

28 Controlled & Modified Release

25 Thickeners and Stabilizers

TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons