FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

Data Compilation
#PharmaFlow

Pipeline Prospector August 2025: Novo’s Wegovy approved for MASH, Tonix Pharma’s fibromyalgia drug okayed

Stock Recap
#PipelineProspector

CTY

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

115 API Suppliers, 23 USDMF, 20 CEP/COS, 16 JDMF, 4 EU WC, 58 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

103 Drugs in Development

103 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

513 FDF Dossiers, 50 FDA Orange Book, 229 Europe, 24 Canada, 8 Australia, 37 South Africa, 165 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML, FOR SUSPENSION;ORAL - 250MG/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 2 Rochem International Inc, 9 SPI Pharma, 15 DKSH, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 28 BASF, 3 CD Formulation, 2 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 10 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 15 Microlex e.U, 3 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

70 Coating Systems & Additives, 69 Fillers, Diluents & Binders, 40 Thickeners and Stabilizers, 38 Solubilizers, 36 Controlled & Modified Release, 30 Topical, 29 Disintegrants & Superdisintegrants, 28 Granulation, 25 Lubricants & Glidants, 25 Direct Compression, 24 Parenteral, 21 Film Formers & Plasticizers, 15 Emulsifying Agents, 15 Taste Masking, 13 Co-Processed Excipients, 10 Rheology Modifiers, 10 Chewable & Orodispersible Aids, 9 Surfactant & Foaming Agents, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

27 News #PharmaBuzz

27 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 206 Regulatory FDF Prices

MARKET PLACE

43 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

57 Health Canada Patents

57 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 8 USP, 12 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
05/06/2025	Century Pharmaceuticals	India	M/s Century Pharmaceuticals Limited	WC-0293	Clarithromycin BP/EP/USP	2022-11-02	2024-12-16	103-106, GIDC Halol, Dist.-Panchmahal, Pin-389350, Gujarat, India
06/09/2025	Sun Pharmaceutical Industries Limited	India	M/sSun Pharmaceutical Industries Ltd	WC-0216	Clarithromycin Ph. Eur	10-07-2025	04-07-2028	Industrial Area-03, A. B. Road, Dewas — 455 001, Madhya Pradesh, India.

CTY

CTY

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

115 API Suppliers

23 USDMF

20 CEP/COS

16 JDMF

4 EU WC

58 KDMF

12 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

103 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

513 FDF Dossiers

50 FDA Orange Book

229 Europe

24 Canada

8 Australia

37 South Africa

165 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML

FOR SUSPENSION;ORAL - 250MG/5ML

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

2 Rochem International Inc

9 SPI Pharma

15 DKSH

1 Pharm-RX Chemical

4 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

7 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

1 Avesta Pharma

28 BASF

3 CD Formulation

2 Clariant

14 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

10 Ideal Cures

4 Ingredion Pharma Solutions

22 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

15 Microlex e.U

3 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

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

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons