Terbinafine HCl

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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 14 EU WC, 37 KDMF, 24 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 13 Canada, 15 South Africa, 23 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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET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, 3 Seqens, 2 DKSH, 3 Faran Shimi Pharmaceutical, 8 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, 27 Controlled & Modified Release, 24 Disintegrants & Superdisintegrants, 24 Fillers, Diluents & Binders, 23 Topical, 21 Thickeners and Stabilizers, 18 Direct Compression, 17 Solubilizers, 15 Granulation, 15 Lubricants & Glidants, 11 Emulsifying Agents, 8 Co-Processed Excipients, 7 Parenteral, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Coloring Agents

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2 DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

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1 US Medicaid Prescriptions, 34 Finished Drug Prices

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17 APIs

17 APIs

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

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1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 22071 / DOSAGE - GRANULE;ORAL - EQ 125MG BASE/PACKET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TERBINAFINE HYDROCHLORIDE(UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE	125mg \| 187.5mg

Inactive Ingredients

Ingredient Name	Novartis Pharmaceuticals Corporation
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
DIBUTYL SEBACATE(4W5IH7FLNY)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
NITROGEN(N762921K75)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)

Drug Product Composition: Terbinafine HCl

Terbinafine HCl

Terbinafine HCl

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

58 API Suppliers

27 USDMF

24 CEP/COS

17 JDMF

14 EU WC

37 KDMF

24 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers

25 FDA Orange Book

68 Europe

13 Canada

15 South Africa

23 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

3 Seqens

2 DKSH

3 Faran Shimi Pharmaceutical

8 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

27 Controlled & Modified Release

24 Disintegrants & Superdisintegrants

24 Fillers, Diluents & Binders

23 Topical

21 Thickeners and Stabilizers

18 Direct Compression

17 Solubilizers

15 Granulation

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