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

Terbinafine HCl

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 11 EU WC, 36 KDMF, 22 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

146 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 12 Canada, 15 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 Seqens, 4 DKSH, 4 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Esteem Industries, 3 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 10 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

38 Coating Systems & Additives, 24 Topical, 23 Disintegrants & Superdisintegrants, 23 Fillers, Diluents & Binders, 22 Thickeners and Stabilizers, 20 Controlled & Modified Release, 17 Solubilizers, 15 Granulation, 14 Lubricants & Glidants, 12 Direct Compression, 12 Emulsifying Agents, 7 Co-Processed Excipients, 6 Film Formers & Plasticizers, 6 Taste Masking, 5 Parenteral, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 2 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 34 Regulatory FDF Prices

MARKET PLACE

17 APIs

17 APIs

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 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	M/s Dr. Reddys Laboratories Limited	WC-0035	Terbinafine Hydrochloride 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	Tagoor Laboratories	India	M/s Tagoor Laboratories Pvt ltd	WC-0494	Terbinafine Hydrochloride IP/BP	2024-08-16	2027-02-26	(Unit-1), Sy No 29, Tupakulagudem (V), Pochavaram Panchayat, Tallapudi (M), West Godavari, Dist-534341, A.P, India

Terbinafine HCl

Terbinafine HCl

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

94 API Suppliers

27 USDMF

24 CEP/COS

17 JDMF

11 EU WC

36 KDMF

22 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

146 FDF Dossiers

25 FDA Orange Book

68 Europe

12 Canada

15 South Africa

26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

CREAM;TOPICAL - 1%

SOLUTION;TOPICAL - 1%

GRANULE;ORAL - EQ 125MG BASE/PACKET

GRANULE;ORAL - EQ 187.5MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

1 Seqens

4 DKSH

4 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 ACG Worldwide

4 Actylis

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

21 BASF

10 Corel Pharma Chem

4 DFE Pharma

2 Esteem Industries

3 Finar

8 Gangwal Chemicals

4 Ideal Cures

2 Ingredion Pharma Solutions

10 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

3 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

10 Roquette

8 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

38 Coating Systems & Additives

24 Topical

23 Disintegrants & Superdisintegrants

23 Fillers, Diluents & Binders

22 Thickeners and Stabilizers

20 Controlled & Modified Release

17 Solubilizers

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