Ethinyl Estradiol

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 13 USDMF, 10 CEP/COS, 4 JDMF, 2 EU WC, 13 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

712 FDF Dossiers, 418 FDA Orange Book, 108 Europe, 88 Canada, 56 South Africa, 42 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- 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE,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- 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL -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

2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 4 DKSH, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 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, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 35 Direct Compression, 33 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 26 Granulation, 25 Thickeners and Stabilizers, 21 Lubricants & Glidants, 18 Co-Processed Excipients, 16 Taste Masking, 16 Solubilizers, 12 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 150 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

31 US Medicaid Prescriptions, 102 Finished Drug Prices, 22 Annual Reports

MARKET PLACE

17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

30 US Patents, 1 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 3 JP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21090 / DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

Inactive Ingredients

Ingredient Name	Mayne Pharma Inc.
ALPHA-TOCOPHEROL(H4N855PNZ1)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Ethinyl Estradiol