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

Hiconcil

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 40 USDMF, 30 CEP/COS, 5 JDMF, 2 EU WC, 37 KDMF, 21 NDC API, 4 VMF, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

126 Drugs in Development

126 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1498 FDF Dossiers, 208 FDA Orange Book, 570 Europe, 115 Canada, 71 Australia, 146 South Africa, 388 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Rochem International Inc, 1 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 1 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 22 Thickeners and Stabilizers, 22 Fillers, Diluents & Binders, 19 Controlled & Modified Release, 14 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 10 Topical, 9 Direct Compression, 9 Granulation, 7 Rheology Modifiers, 7 Co-Processed Excipients, 6 Film Formers & Plasticizers, 5 Taste Masking, 5 Solubilizers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Coloring Agents, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 1 Parenteral

DIGITAL CONTENT

77 News #PharmaBuzz

77 News #PharmaBuzz

GLOBAL SALES INFORMATION

25 US Medicaid Prescriptions, 545 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

105 APIs, 44 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 6 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 22 Others

ANALYTICAL

3 Analytical Methods

3 Analytical 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	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0023	Amoxicillin Trihydrate 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
04/06/2025	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0121	Amoxicillin Trihydrate Ph. Eur.	2022-08-02	2025-07-02	Plot No. 68-70, 73-91, 95, 96, 260, 261, IDA, Pashamylaram (village), Patancheru (Mandal), Sangareddy District, Pincode ?502307, Telangana, India

Hiconcil

Hiconcil

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

107 API Suppliers

40 USDMF

30 CEP/COS

5 JDMF

2 EU WC

37 KDMF

21 NDC API

4 VMF

26 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

126 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1498 FDF Dossiers

208 FDA Orange Book

570 Europe

115 Canada

71 Australia

146 South Africa

388 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

TABLET;ORAL - 875MG;EQ 125MG BASE

FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

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

TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/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**

FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 400MG/5ML

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 775MG

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 Rochem International Inc

1 SPI Pharma

7 DKSH

1 Pharm-RX Chemical

3 Gangwal Healthcare

1 Kirsch Pharma

1 ACG Worldwide

3 Actylis

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 BASF

2 CD Formulation

10 Corel Pharma Chem

3 DFE Pharma

1 Esteem Industries

1 Finar

6 Gangwal Chemicals

4 Ideal Cures

1 Ingredion Pharma Solutions

10 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

1 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

11 Roquette

6 Seppic

TABLET;ORAL - 250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 125MG BASE 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

TABLET;ORAL - 875MG 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

FOR SUSPENSION;ORAL - 200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE 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