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

41 API Suppliers, 10 USDMF, 6 CEP/COS, 7 JDMF, 2 EU WC, 4 KDMF, 2 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

105 Drugs in Development

105 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

684 FDF Dossiers, 60 FDA Orange Book, 343 Europe, 3 Canada, 22 Australia, 88 South Africa, 168 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, SUSPENSION;OTIC - 6% (60MG/ML), SUSPENSION/DROPS;OTIC - 0.3%;0.1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 5 SPI Pharma, 7 DKSH, 10 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 35 BASF, 1 BioSpectra, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Esteem Industries, 2 Finar, 14 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 30 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 36 Thickeners and Stabilizers, 35 Granulation, 33 Direct Compression, 32 Solubilizers, 29 Parenteral, 28 Controlled & Modified Release, 23 Topical, 21 Lubricants & Glidants, 19 Film Formers & Plasticizers, 16 Taste Masking, 14 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 10 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

58 News #PharmaBuzz

58 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 336 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

72 APIs, 38 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 18 Others

ANALYTICAL

2 BioAnalytical Methods

2 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	Neuland Laboratories	India	M/sNeuland Laboratories ltd	WC-0037	Ciprofloxacin USP/Ph. Eur	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
06/09/2025	Sun Pharmaceutical Industries Limited	India	M/sSun Pharmaceutical Industries Ltd	WC-0216	Ciprofloxacin Ph. Eur	10-07-2025	04-07-2028	Industrial Area-03, A. B. Road, Dewas — 455 001, Madhya Pradesh, India.

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

41 API Suppliers

10 USDMF

6 CEP/COS

7 JDMF

2 EU WC

4 KDMF

2 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

105 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

684 FDF Dossiers

60 FDA Orange Book

343 Europe

3 Canada

22 Australia

88 South Africa

168 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE, SUSPENSION;OTIC - 6% (60MG/ML)

SUSPENSION/DROPS;OTIC - 0.3%;0.1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

5 SPI Pharma

7 DKSH

10 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

2 Pfanstiehl

7 Kirsch Pharma

1 ACG Worldwide

12 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

35 BASF

1 BioSpectra

1 Clariant

11 Corel Pharma Chem

6 DFE Pharma

2 Esteem Industries

2 Finar

14 Gangwal Chemicals

5 Ideal Cures

4 Ingredion Pharma Solutions

22 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

2 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

30 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

3 The Dow Chemical Company

INJECTABLE;INJECTION - 200MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 400MG/200ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons