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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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Synflex

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ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 22 USDMF, 8 CEP/COS, 4 EU WC, 34 KDMF, 10 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

150 FDF Dossiers, 85 FDA Orange Book, 11 Europe, 18 Canada, 4 South Africa, 32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 11 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 12 DKSH, 8 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 3 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 38 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 49 Controlled & Modified Release, 45 Thickeners and Stabilizers, 44 Disintegrants & Superdisintegrants, 40 Solubilizers, 39 Direct Compression, 31 Granulation, 30 Film Formers & Plasticizers, 29 Parenteral, 26 Taste Masking, 25 Topical, 23 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 12 Rheology Modifiers, 9 Empty Capsules, 9 Emulsifying Agents, 8 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

44 News #PharmaBuzz

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Regulatory FDF Prices

MARKET PLACE

38 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 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
28/03/2025	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	3208	NAPROXEN SODIUM	1978-05-25	Active	II	Complete	2015-03-26	2015-03-19
28/03/2025	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	12342	NAPROXEN SODIUM	1997-01-28	Active	II	Complete	2013-01-30	2013-01-16

Synflex

Synflex

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers

22 USDMF

8 CEP/COS

4 EU WC

34 KDMF

10 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

150 FDF Dossiers

85 FDA Orange Book

11 Europe

18 Canada

4 South Africa

32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 500MG BASE

TABLET;ORAL - 220MG

TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

CAPSULE;ORAL - EQ 200MG BASE

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI

11 Evonik

4 Rochem International Inc

20 SPI Pharma

12 DKSH

8 Faran Shimi Pharmaceutical

11 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

11 Actylis

2 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

33 BASF

3 Clariant

17 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

4 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

9 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

38 Roquette

13 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

3 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons