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Approved Drug Products containing Terbinafine Hydrochloride listed with Health Canada. Original Data : Health Canada Website

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Product

Terbinafine Hydrochloride
CAS 14489-75-9
Canada

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Terbinafine Hydrochloride

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 27 USDMF, 23 CEP/COS, 17 JDMF, 14 EU WC, 35 KDMF, 26 NDC API, 27 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

7 API Suppliers

7 API Suppliers

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 13 Canada, 15 South Africa, 23 Listed Dossiers

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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 1 Jai Radhe Sales, 8 Gangwal Healthcare, 6 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, 25 Fillers, Diluents & Binders, 24 Disintegrants & Superdisintegrants, 23 Topical, 21 Thickeners and Stabilizers, 18 Direct Compression, 17 Solubilizers, 15 Granulation, 15 Lubricants & Glidants, 11 Emulsifying Agents, 8 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Taste Masking, 6 Parenteral, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Coloring Agents

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
2 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 34 Finished Drug Prices

1 US Medicaid Prescriptions
34 Finished Drug 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

2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 150 Xls

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13 All

01 1APOTEX INC

02 1AURO PHARMA INC

03 1ELANCO CANADA LIMITED

04 3NOVARTIS PHARMACEUTICALS CANADA INC

05 1PHARMASCIENCE INC

06 1PRO DOC LIMITEE

07 2Pharmascience Inc.

08 1SANIS HEALTH INC

09 1SIVEM PHARMACEUTICALS ULC

10 1TEVA CANADA LIMITED

filter Active Ingredients Reset all filters

13 All

01 9TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

02 2TERBINAFINE HYDROCHLORIDE

03 2Terbinafine Hydrochloride

filter Dosage Form Reset all filters

13 All

01 1CREAM

02 1SOLUTION

03 1SPRAY

04 10TABLET

filter Brand Name Reset all filters

13 All

01 1ACT TERBINAFINE

02 1APO-TERBINAFINE

03 1AURO-TERBINAFINE

04 1CLARO

05 3LAMISIL

06 3PMS-TERBINAFINE

07 2TERBINAFINE

08 1TERBINAFINE-250

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

APOTEX INC

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APOTEX INC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : APO-TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 100

Approval Date :

Application Number : 2239893

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

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02

AURO PHARMA INC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : AURO-TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 28/100

Approval Date :

Application Number : 2320134

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

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03

NOVARTIS PHARMACEUTICALS CANADA INC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : LAMISIL

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 14/28

Approval Date :

Application Number : 2031116

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

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Corporate PDF

04

NOVARTIS PHARMACEUTICALS CANADA INC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : CREAM

Dosage Strength : 1%/%

Packaging : 30G

Approval Date :

Application Number : 2031094

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

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Digital Content

Corporate PDF

05

NOVARTIS PHARMACEUTICALS CANADA INC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : SPRAY

Dosage Strength : 1%/W/W

Packaging : 30ML

Approval Date :

Application Number : 2238703

Regulatory Info : Prescription

Registration Country : Canada

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06

Pharmascience Inc.

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Regulatory Info : Prescription

Registration Country : Canada

Terbinafine Hydrochloride

Brand Name : PMS-TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 100

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

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07

Pharmascience Inc.

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Regulatory Info : Prescription

Registration Country : Canada

Terbinafine Hydrochloride

Brand Name : PMS-TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 100/30

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Canada

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Digital Content

08

PRO DOC LIMITEE

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PRO DOC LIMITEE

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : TERBINAFINE-250

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 100

Approval Date :

Application Number : 2242735

Regulatory Info : Prescription

Registration Country : Canada

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09

SIVEM PHARMACEUTICALS ULC

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 30/100

Approval Date :

Application Number : 2385279

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

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Corporate PDF

10

TEVA CANADA LIMITED

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TEVA CANADA LIMITED

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Regulatory Info : Prescription

Registration Country : Canada

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Brand Name : ACT TERBINAFINE

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : 30/100

Approval Date :

Application Number : 2254727

Regulatory Info : Prescription

Registration Country : Canada

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