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Terbinafine HCl

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 14 EU WC, 35 KDMF, 24 NDC API, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 13 Canada, 15 South Africa, 24 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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET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, 3 Faran Shimi Pharmaceutical, 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, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 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, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 26 Controlled & Modified Release, 23 Topical, 23 Disintegrants & Superdisintegrants, 22 Thickeners and Stabilizers, 22 Fillers, Diluents & Binders, 17 Solubilizers, 15 Granulation, 14 Lubricants & Glidants, 12 Direct Compression, 11 Emulsifying Agents, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 Rheology Modifiers, 5 Parenteral, 5 Co-Processed Excipients, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Chewable & Orodispersible Aids, 2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 2 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 34 Regulatory FDF Prices

MARKET PLACE

17 APIs

17 APIs

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	15887	TERBINAFINE HYDROCHLORIDE USP	2002-03-06	Active	II	N/A
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	18758	TERBINAFINE HYDROCHLORIDE	2005-09-12	Inactive	II	N/A

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

14 EU WC

35 KDMF

24 NDC API

26 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers

25 FDA Orange Book

68 Europe

13 Canada

15 South Africa

24 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

3 Faran Shimi Pharmaceutical

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

3 Finar

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

16 Kerry

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

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

2 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives

26 Controlled & Modified Release

23 Topical

23 Disintegrants & Superdisintegrants

22 Thickeners and Stabilizers

22 Fillers, Diluents & Binders

17 Solubilizers

15 Granulation

14 Lubricants & Glidants

12 Direct Compression

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