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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM,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

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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

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1 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

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

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PATENTS & EXCLUSIVITIES

131 US Patents, 6 US Exclusivities

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4 EDQM, 3 USP, 4 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20907 / DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	1mg \| 0.5mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE ACETATE	0.5mg \| 0.1mg

Inactive Ingredients

Ingredient Name	Amneal Pharmaceuticals LLC	Amneal Pharmaceuticals NY LLC	Gemini Laboratories, LLC	Novo Nordisk
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Estradiol

Estradiol

Estradiol

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CHEMISTRY

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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

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