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

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

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 12 USDMF, 11 CEP/COS, 3 JDMF, 9 EU WC, 2 KDMF, 6 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

38 Drugs in Development

38 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 31 FDA Orange Book, 191 Europe, 15 Canada, 6 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 6 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 27 BASF, 1 Corel Pharma Chem, 3 DFE Pharma, 1 Doshion Polyscience, 2 Esteem Industries, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures, 3 Ingredion Pharma Solutions, 1 Kerry, 2 Keval Exports, 8 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 25 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders, 22 Direct Compression, 20 Disintegrants & Superdisintegrants, 20 Granulation, 20 Solubilizers, 20 Thickeners and Stabilizers, 17 Topical, 16 Film Formers & Plasticizers, 16 Lubricants & Glidants, 15 Taste Masking, 13 Coating Systems & Additives, 13 Co-Processed Excipients, 12 Controlled & Modified Release, 11 Parenteral, 9 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

8 News #PharmaBuzz

8 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 155 Regulatory FDF Prices, 5 Annual Reports

MARKET PLACE

7 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 6 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ 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
06/09/2025	Dr. Reddy's Laboratories	India	Dr. Reddys Laboratories Ltd.	WC-0034	Repaglinide USP/Ph. Eur.	2025-07-25	2028-06-16	Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Industrial Estate, Bollaram (V), Jinnaram (M), Sangareddy (Dist.), Telangana, India
06/09/2025	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0023	Repaglinide Ph.Eur	07-11-2025	25-06-2028	Sy. No’s. 52,53,58,59,61 to 78, 127 & 128,Pydibhimavaram Village & Sy. No’s. 1,2,4 to 9,11,29,30,31 & 32,Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India, PIN: 532409

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

29 API Suppliers

12 USDMF

11 CEP/COS

3 JDMF

9 EU WC

2 KDMF

6 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

38 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers

31 FDA Orange Book

191 Europe

15 Canada

6 South Africa

25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;1MG

TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

6 SPI Pharma

3 DKSH

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Kirsch Pharma

5 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

27 BASF

1 Corel Pharma Chem

3 DFE Pharma

1 Doshion Polyscience

2 Esteem Industries

2 Finar

9 Gangwal Chemicals

1 Ideal Cures

3 Ingredion Pharma Solutions

1 Kerry

2 Keval Exports

8 Microlex e.U

2 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

25 Roquette

1 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 Silverline Chemicals

1 Ulanqab Kema New Material

2 Valens Pharmachem

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders

22 Direct Compression

20 Disintegrants & Superdisintegrants

TABLET;ORAL - 0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons