Estradiol

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 9 CEP/COS, 2 JDMF, 2 EU WC, 10 KDMF, 33 NDC API, 4 VMF, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

534 FDF Dossiers, 223 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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM,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, 2 Jai Radhe Sales, 2 Nippon Fine Chemical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 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 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, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 46 Direct Compression, 35 Controlled & Modified Release, 34 Solubilizers, 34 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 31 Granulation, 31 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 17 Taste Masking, 15 Emulsifying Agents, 9 API Stability Enhancers, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

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 - 20907 / DOSAGE - TABLET;ORAL - 1MG;0.5MG

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	Lupin Pharmaceuticals, Inc.	Mylan Pharmaceuticals Inc.	Naari Pte. Limited	Gemini Laboratories, LLC	Novo Nordisk
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
FD&C YELLOW NO. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYSORBATE 80(6OZP39ZG8H)
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

30 API Suppliers

11 USDMF

9 CEP/COS

2 JDMF

2 EU WC

10 KDMF

33 NDC API

4 VMF

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

39 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

534 FDF Dossiers

223 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

2 Jai Radhe Sales

2 Nippon Fine Chemical

6 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

2 Pfanstiehl

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