Terbinafine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

97 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 12 EU WC, 37 KDMF, 23 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

118 FDF Dossiers, 25 FDA Orange Book, 39 Europe, 13 Canada, 16 South Africa, 25 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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET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 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Rheology Modifiers, 5 Parenteral, 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, 16 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

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USFDA APPLICATION NUMBER - 20539 / DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TERBINAFINE HYDROCHLORIDE(UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE	250mg

Inactive Ingredients

Ingredient Name	Novartis Pharmaceuticals Corporation
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)

Setid 7c6c1494 Fb92 4442 Bcff 764b77397495 Applno 20539 Form Tablet Oral Dosage Eq 250mg Base - Drug Product Composition: Terbinafine Hydrochloride