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Levothyroxine

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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 15 USDMF, 10 CEP/COS, 2 JDMF, 5 EU WC, 5 KDMF, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

595 FDF Dossiers, 263 FDA Orange Book, 187 Europe, 29 Canada, 37 Australia, 24 South Africa, 55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG, TABLET;ORAL - 0.025MG;0.0063MG, TABLET;ORAL - 0.05MG;0.0125MG, TABLET;ORAL - 0.15MG;0.0375MG, TABLET;ORAL - 0.1MG;0.025MG, POWDER;INTRAVENOUS - 100MCG/VIAL, POWDER;INTRAVENOUS - 200MCG/VIAL, POWDER;INTRAVENOUS - 500MCG/VIAL, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, CAPSULE;ORAL - 0.013MG, CAPSULE;ORAL - 0.025MG, CAPSULE;ORAL - 0.0375MG, CAPSULE;ORAL - 0.044MG, CAPSULE;ORAL - 0.05MG, CAPSULE;ORAL - 0.0625MG, CAPSULE;ORAL - 0.075MG, CAPSULE;ORAL - 0.088MG, CAPSULE;ORAL - 0.112MG, CAPSULE;ORAL - 0.125MG, CAPSULE;ORAL - 0.137MG, CAPSULE;ORAL - 0.15MG, CAPSULE;ORAL - 0.175MG, CAPSULE;ORAL - 0.1MG, CAPSULE;ORAL - 0.2MG

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 20 SPI Pharma, 7 DKSH, 1 Jai Radhe Sales, 9 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 2 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 43 Direct Compression, 30 Disintegrants & Superdisintegrants, 28 Thickeners and Stabilizers, 26 Controlled & Modified Release, 26 Granulation, 24 Taste Masking, 20 Parenteral, 20 Lubricants & Glidants, 18 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 15 Solubilizers, 9 Film Formers & Plasticizers, 9 Empty Capsules, 7 API Stability Enhancers, 6 Emulsifying Agents, 6 Topical, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

8 DATA COMPILATION #PharmaFlow, 86 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 177 Finished Drug Prices, 8 Annual Reports

MARKET PLACE

30 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

125 US Patents

125 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Fareva	Luxembourg	EXCELLA GMBH AND CO KG	24402	LEVOTHYROXINE SODIUM	2011-10-20	Active	II	Complete	2014-06-23	2013-09-26
28/10/2024	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INDIA PVT LTD	30113	LEVOTHYROXINE SODIUM USP	2016-03-01	Inactive	II	N/A

Levothyroxine

Levothyroxine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

28 API Suppliers

15 USDMF

10 CEP/COS

2 JDMF

5 EU WC

5 KDMF

20 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

595 FDF Dossiers

263 FDA Orange Book

187 Europe

29 Canada

37 Australia

24 South Africa

55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG

TABLET;ORAL - 0.025MG;0.0063MG

TABLET;ORAL - 0.05MG;0.0125MG

TABLET;ORAL - 0.15MG;0.0375MG

TABLET;ORAL - 0.1MG;0.025MG

POWDER;INTRAVENOUS - 100MCG/VIAL

POWDER;INTRAVENOUS - 200MCG/VIAL

POWDER;INTRAVENOUS - 500MCG/VIAL

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

CAPSULE;ORAL - 0.013MG

CAPSULE;ORAL - 0.025MG

CAPSULE;ORAL - 0.0375MG

CAPSULE;ORAL - 0.044MG

CAPSULE;ORAL - 0.05MG

CAPSULE;ORAL - 0.0625MG

CAPSULE;ORAL - 0.075MG