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

131 API Suppliers, 29 USDMF, 11 JDMF, 18 EU WC, 73 KDMF, 19 NDC API, 50 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

151 Drugs in Development

151 Drugs in Development

INTERMEDIATES

31 Intermediate Suppliers

31 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

621 FDF Dossiers, 70 FDA Orange Book, 356 Europe, 20 Canada, 25 Australia, 42 South Africa, 108 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 6 SPI Pharma, 6 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Kirsch Pharma, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 19 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 34 Direct Compression, 32 Granulation, 22 Lubricants & Glidants, 20 Thickeners and Stabilizers, 19 Controlled & Modified Release, 12 Chewable & Orodispersible Aids, 10 Co-Processed Excipients, 10 Taste Masking, 9 Solubilizers, 8 Film Formers & Plasticizers, 7 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Emulsifying Agents, 2 Topical, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

115 News #PharmaBuzz

115 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 329 Regulatory FDF Prices, 65 Annual Reports

MARKET PLACE

22 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 3 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 4 Others

ANALYTICAL

6 BioAnalytical Methods

6 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	M/s Dr Reddy's Laboratories Limited	WC-0067	Ezetimibe IH/USP	15-07-2025	07-07-2028	Chemical Technical Operation’s Unit-VI,APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal,Srikakulam District -532409, Andhra Pradesh, India
06/09/2025	Neuland Laboratories	India	M/sNeuland Laboratories ltd	WC-0037	Ezetimibe IH/USP	27-06-2025	16-06-2028	Unit-ll, Plot No. 92-94, 257-259, IDA Pashamylaram, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Pin code-502 307, Telangana State, India

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

131 API Suppliers

29 USDMF

11 JDMF

18 EU WC

73 KDMF

19 NDC API

50 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

151 Drugs in Development

INTERMEDIATES

31 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

621 FDF Dossiers

70 FDA Orange Book

356 Europe

20 Canada

25 Australia

42 South Africa

108 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG

TABLET;ORAL - 10MG;10MG

TABLET;ORAL - 10MG;20MG

TABLET;ORAL - 10MG;40MG

TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem

6 SPI Pharma

6 DKSH

5 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

3 Kirsch Pharma

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

19 BASF

2 CD Formulation

10 Corel Pharma Chem

7 DFE Pharma

8 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

3 Nitika Pharmaceutical Specialities

3 Novo Excipients

5 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders

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

TABLET;ORAL - EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons