Estradiol

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 11 USDMF, 11 CEP/COS, 2 JDMF, 2 EU WC, 10 KDMF, 31 NDC API, 4 VMF, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

535 FDF Dossiers, 224 FDA Orange Book, 222 Europe, 29 Canada, 23 Australia, 27 South Africa, 10 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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM,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

1 Rochem International Inc, 8 SPI Pharma, 2 Seqens, 10 DKSH, 6 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 1 BioSpectra, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 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, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 45 Direct Compression, 35 Controlled & Modified Release, 33 Solubilizers, 33 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 31 Topical, 31 Granulation, 24 Film Formers & Plasticizers, 23 Parenteral, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 17 Taste Masking, 15 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 8 Chewable & Orodispersible Aids, 7 Surfactant & Foaming Agents, 5 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 126 Finished Drug Prices, 7 Annual Reports

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10 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

131 US Patents, 6 US Exclusivities

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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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

Estradiol

Estradiol

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers

11 USDMF

11 CEP/COS

2 JDMF

2 EU WC

10 KDMF

31 NDC API

4 VMF

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

535 FDF Dossiers

224 FDA Orange Book

222 Europe

29 Canada

23 Australia

27 South Africa

10 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

1 Rochem International Inc

8 SPI Pharma

2 Seqens

10 DKSH

6 Faran Shimi Pharmaceutical

6 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

8 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

8 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

33 BASF

1 BioSpectra

TABLET;ORAL - 0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;VAGINAL - 25MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons