[{"orgOrder":0,"company":"Moberg Pharma","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Approved FDF","graph3":"Moberg Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Solution","sponsorNew":"Moberg Pharma \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Moberg Pharma \/ Inapplicable"},{"orgOrder":0,"company":"Moberg Pharma","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Approved FDF","graph3":"Moberg Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Solution","sponsorNew":"Moberg Pharma \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Moberg Pharma \/ Inapplicable"},{"orgOrder":0,"company":"Moberg Pharma","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Approved FDF","graph3":"Moberg Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Solution","sponsorNew":"Moberg Pharma \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Moberg Pharma \/ Inapplicable"},{"orgOrder":0,"company":"Moberg Pharma","sponsor":"Padagis","pharmaFlowCategory":"D","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Agreement","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Approved FDF","graph3":"Moberg Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Solution","sponsorNew":"Moberg Pharma \/ Padagis","highestDevelopmentStatusID":"15","companyTruncated":"Moberg Pharma \/ Padagis"},{"orgOrder":0,"company":"Blueberry Therapeutics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"UNITED KINGDOM","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Blueberry Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Spray","sponsorNew":"Blueberry Therapeutics \/ Inapplicable","highestDevelopmentStatusID":"8","companyTruncated":"Blueberry Therapeutics \/ Inapplicable"},{"orgOrder":0,"company":"Blueberry Therapeutics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"UNITED KINGDOM","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Terbinafine Hydrochloride","moa":"Squalene monooxygenase","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Blueberry Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Topical Spray","sponsorNew":"Blueberry Therapeutics \/ Inapplicable","highestDevelopmentStatusID":"8","companyTruncated":"Blueberry Therapeutics \/ Inapplicable"}]

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Terbinafine HCl

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 27 USDMF, 24 CEP/COS, 17 JDMF, 11 EU WC, 36 KDMF, 22 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

146 FDF Dossiers, 25 FDA Orange Book, 68 Europe, 12 Canada, 15 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

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 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, 34 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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01

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Lead Product(s) : Terbinafine Hydrochloride

Therapeutic Area : Undisclosed

Study Phase : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 31, 2011

Lead Product(s) : Terbinafine Hydrochloride

Therapeutic Area : Undisclosed

Highest Development Status : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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02

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Lead Product(s) : Terbinafine Hydrochloride

Therapeutic Area : Undisclosed

Study Phase : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 31, 2011

Lead Product(s) : Terbinafine Hydrochloride

Therapeutic Area : Undisclosed

Highest Development Status : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Dr Reddy Company Banner

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03

Moberg Pharma

U.S.A

ChemOutsourcing

Not Confirmed

04

Moberg Pharma

U.S.A

ChemOutsourcing

Not Confirmed

05

Blueberry Therapeutics

United Kingdom

ChemOutsourcing

Not Confirmed

06

Moberg Pharma

U.S.A

ChemOutsourcing

Not Confirmed

07

Moberg Pharma

U.S.A

ChemOutsourcing

Not Confirmed

08

Blueberry Therapeutics

United Kingdom

ChemOutsourcing

Not Confirmed

09

UNITED LABORATORIES

U.S.A

ChemOutsourcing

Not Confirmed

10

Polichem S.A.

Switzerland

ChemOutsourcing

Not Confirmed

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