Terbinafine HCl | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Terbinafine HCl
South Africa

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Terbinafine Hydrochloride

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Terbinafine HCl

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 27 USDMF, 25 CEP/COS, 17 JDMF, 11 EU WC, 37 KDMF, 22 NDC API, 25 Listed Suppliers, $ API Reference Price

95 API Suppliers
27 USDMF
25 CEP/COS
17 JDMF
11 EU WC
37 KDMF
22 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

106 FDF Dossiers, 25 FDA Orange Book, 39 Europe, 10 Canada, 6 South Africa, 26 Listed Dossiers

106 FDF Dossiers
25 FDA Orange Book
39 Europe
10 Canada
6 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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, SOLUTION;TOPICAL - 1%, GRANULE;ORAL - EQ 125MG BASE/PACKET, GRANULE;ORAL - EQ 187.5MG BASE/PACKET

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Coloring Agents

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 Chewable & Orodispersible Aids
4 Vegetarian Capsules
4 API Stability Enhancers
2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 2 News #PharmaBuzz

1 Data Compilation #PharmaFlow
2 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 16 Regulatory FDF Prices

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

2 EDQM
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 148 Xls

Filters

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filter Applicant Reset all filters

6 All

01 1Activo Health (Pty) Ltd

02 5GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 5Terbinafine Hcl

02 1Terbinafine Hydrochoride

filter Dosage Form Reset all filters

6 All

01 2CRE

02 1SOL

03 2SPO

04 1TAB

filter Brand Name Reset all filters

6 All

01 2Lamisil Cream

02 1Lamisil Film Forming Solution Once

03 2Lamisil Spray

04 1Terbi-Clear

List of Suppliers

Product Main Page

01

Activo Health (Pty) Ltd

PackExpo

Not Confirmed

Activo Health (Pty) Ltd

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Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Terbinafine Hydrochoride

Brand Name : Terbi-Clear

Dosage Form : TAB

Dosage Strength : 250mg

Packaging : 14X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Terbinafine Hcl

Brand Name : Lamisil Spray

Dosage Form : SPO

Dosage Strength : 10mg/g

Packaging : 15X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

GlaxoSmithKline Consumer Healthcare Sout...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Terbinafine Hcl

Brand Name : Lamisil Film Forming Solution Once

Dosage Form : SOL

Dosage Strength : 10mg/g

Packaging : 4X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Terbinafine Hcl

Brand Name : Lamisil Cream

Dosage Form : CRE

Dosage Strength : 10mg/g

Packaging : 15X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Terbinafine Hcl

Brand Name : Lamisil Cream

Dosage Form : CRE

Dosage Strength : 10mg/g

Packaging : 7.5X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

GlaxoSmithKline Consumer Healthcare Sout...

PackExpo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Terbinafine Hcl

Brand Name : Lamisil Spray

Dosage Form : SPO

Dosage Strength : 10mg/g

Packaging : 30X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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