Ethinyl Estradiol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 14 USDMF, 10 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

99 Drugs in Development

99 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1191 FDF Dossiers, 420 FDA Orange Book, 526 Europe, 121 Canada, 3 Australia, 75 South Africa, 46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, TABLET;ORAL - 0.02MG;0.1MG, RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR, TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 3MG;0.02MG, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 25 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 31 Disintegrants & Superdisintegrants, 31 Granulation, 30 Direct Compression, 26 Controlled & Modified Release, 25 Thickeners and Stabilizers, 20 Lubricants & Glidants, 16 Solubilizers, 15 Taste Masking, 13 Topical, 12 Co-Processed Excipients, 9 Film Formers & Plasticizers, 8 Chewable & Orodispersible Aids, 8 Parenteral, 7 API Stability Enhancers, 7 Rheology Modifiers, 6 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 156 News #PharmaBuzz

GLOBAL SALES INFORMATION

143 US Medicaid Prescriptions, 47 Regulatory FDF Prices, 41 Annual Reports

MARKET PLACE

17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

31 US Patents, 1 US Exclusivities, 29 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 JP, 5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 209627 / DOSAGE - RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETHINYL ESTRADIOL(UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	17.4mg
SEGESTERONE ACETATE(UNII: 9AMX4Q13CC) (SEGESTERONE - UNII:09Q5UV3747)	SEGESTERONE ACETATE	103mg

Inactive Ingredients

Ingredient Name	QPharma AB
DIBUTYLTIN DILAURATE(L4061GMT90)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 82dacbf8 5267 4c7f Bf1a F5c755f64619 Applno 209627 Form Ring Vaginal Dosage 0 013mg 24hr 0 15mg 24hr - Drug Product Composition: Ethinyl Estradiol