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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM,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 - 21813 / DOSAGE - GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.6mg in 1

Inactive Ingredients

Ingredient Name	Jazz Pharmaceuticals Commercial Corp.
ALCOHOL(3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E)
DIETHYLENE GLYCOL MONOETHYL ETHER(A1A1I8X02B)
EDETATE DISODIUM(7FLD91C86K)
PROPYLENE GLYCOL(6DC9Q167V3)
TROLAMINE(9O3K93S3TK)
WATER(059QF0KO0R)

Drug Product Composition: Estradiol Hemihydrate