Estradiol Hemihydrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

74 API Suppliers, 11 USDMF, 12 CEP/COS, 2 JDMF, 11 EU WC, 10 KDMF, 37 NDC API, 3 VMF, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

82 Drugs in Development

82 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

701 FDF Dossiers, 229 FDA Orange Book, 379 Europe, 29 Canada, 30 Australia, 27 South Africa, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR, INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR, SYSTEM;TRANSDERMAL - 0.025MG/24HR, SYSTEM;TRANSDERMAL - 0.0375MG/24HR, SYSTEM;TRANSDERMAL - 0.05MG/24HR, SYSTEM;TRANSDERMAL - 0.075MG/24HR, SYSTEM;TRANSDERMAL - 0.1MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 0.25MG;0.5MG, TABLET;ORAL - 0.5MG;1MG, GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION), SPRAY;TRANSDERMAL - 1.53MG/SPRAY, GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET), GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (1GM/PACKET), CREAM;VAGINAL - 0.01%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 8 SPI Pharma, 12 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 33 BASF, 1 BioSpectra, 2 CD Formulation, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 40 Direct Compression, 38 Thickeners and Stabilizers, 36 Granulation, 35 Solubilizers, 34 Topical, 31 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 27 Parenteral, 22 Film Formers & Plasticizers, 21 Lubricants & Glidants, 18 Taste Masking, 17 Emulsifying Agents, 14 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 43 News #PharmaBuzz

GLOBAL SALES INFORMATION

42 US Medicaid Prescriptions, 84 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

14 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

129 US Patents, 4 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 16 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20908 / DOSAGE - TABLET;VAGINAL - 10MCG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESTRADIOL HEMIHYDRATE(UNII: CXY7B3Q98Z) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	10ug

Inactive Ingredients

Ingredient Name	Glenmark Pharmaceuticals Inc., USA	Amneal Pharmaceuticals NY LLC
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Estradiol Hemihydrate