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

Istin, Norvasc, Amlodipine besylate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

191 API Suppliers, 41 USDMF, 44 CEP/COS, 25 JDMF, 39 EU WC, 90 KDMF, 27 NDC API, 59 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

824 FDF Dossiers, 457 FDA Orange Book, 47 Europe, 130 Canada, 50 South Africa, 140 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 22 SPI Pharma, 22 DKSH, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 5 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 35 BASF, 1 CD Formulation, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 49 Direct Compression, 48 Disintegrants & Superdisintegrants, 47 Thickeners and Stabilizers, 38 Solubilizers, 37 Granulation, 31 Lubricants & Glidants, 29 Topical, 29 Controlled & Modified Release, 25 Parenteral, 23 Chewable & Orodispersible Aids, 23 Film Formers & Plasticizers, 20 Taste Masking, 15 Co-Processed Excipients, 14 Rheology Modifiers, 13 Emulsifying Agents, 10 Surfactant & Foaming Agents, 10 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

42 News #PharmaBuzz

42 News #PharmaBuzz

GLOBAL SALES INFORMATION

49 US Medicaid Prescriptions, 40 Regulatory FDF Prices

MARKET PLACE

39 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

37 US Patents, 195 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 3 USP, 7 JP, 1 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
06/09/2025	Dr. Reddy's Laboratories	India	M/s Dr. Reddys Laboratories Limited	WC-0035	Amlodipine Besylate Ph. Eur	28-05-2025	25-06-2028	Chemical Technical Operations, Unit -Ill, Plot No. 116,Sri Venkateswara Co-operative Industrial Estate, IDA,Bollaram (Village), Jinnaram (Mandal), Sangareddy (Dist.),Telangana State, India
04/06/2025	Alkem Laboratories	India	M/s Alkem Laboratories Ltd	WC-0370	Amlodipine Besylate USP	2022-09-30	2025-06-05	Plot No. 288/A, 289-290, G.I.D.C At & Post-Ankleshwar, Dist.- Bharuch, Gujarat, India

Istin, Norvasc, Amlodipine Besylate

Istin, Norvasc, Amlodipine besylate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

191 API Suppliers

41 USDMF

44 CEP/COS

25 JDMF

39 EU WC

90 KDMF

27 NDC API

59 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

30 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

824 FDF Dossiers

457 FDA Orange Book

47 Europe

130 Canada

50 South Africa

140 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE

TABLET;ORAL - EQ 5MG BASE

CAPSULE;ORAL - EQ 10MG BASE;20MG

CAPSULE;ORAL - EQ 10MG BASE;40MG

CAPSULE;ORAL - EQ 2.5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;20MG

CAPSULE;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;14MG

TABLET;ORAL - EQ 2.5MG BASE;3.5MG

TABLET;ORAL - EQ 5MG BASE;7MG

TABLET;ORAL - EQ 10MG BASE;200MG

TABLET;ORAL - EQ 2.5MG BASE;200MG

TABLET;ORAL - EQ 5MG BASE;200MG

TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 10MG BASE;160MG

TABLET;ORAL - EQ 10MG BASE;320MG

TABLET;ORAL - EQ 5MG BASE;160MG

TABLET;ORAL - EQ 5MG BASE;320MG

TABLET;ORAL - EQ 10MG BASE;20MG

TABLET;ORAL - EQ 10MG BASE;40MG

TABLET;ORAL - EQ 5MG BASE;20MG

TABLET;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;320MG

TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 5MG BASE;25MG;160MG

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

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

TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

3 Rochem International Inc

22 SPI Pharma

22 DKSH

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

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

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

TABLET;ORAL - EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons