Ethinylestradiol

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 13 USDMF, 10 CEP/COS, 4 JDMF, 2 EU WC, 13 NDC API, 19 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- 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE,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- 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL -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, 1 Jai Radhe Sales, 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, 9 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, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 36 Direct Compression, 34 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 26 Granulation, 25 Thickeners and Stabilizers, 21 Lubricants & Glidants, 18 Co-Processed Excipients, 17 Solubilizers, 16 Taste Masking, 12 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 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

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USFDA APPLICATION NUMBER - 17354 / DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETHINYL ESTRADIOL(UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	0.02mg \| 0.03mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE ACETATE	1mg \| 1.5mg

Inactive Ingredients

Ingredient Name	Aurobindo Pharma Limited	Afaxys Pharma, LLC.	RPK Pharmaceuticals, Inc.	Actavis Pharma, Inc.	Lupin Pharmaceuticals, Inc.	Mayne Pharma Inc.	Par Pharmaceutical
.ALPHA.-TOCOPHEROL(H4N855PNZ1)
.ALPHA.-TOCOPHEROL, DL-(7QWA1RIO01)
ACACIA(5C5403N26O)
ALPHA-TOCOPHEROL(H4N855PNZ1)
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROUS FUMARATE(R5L488RY0Q)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POVIDONE K25(K0KQV10C35)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE, UNSPECIFIED(FZ989GH94E)
RAW SUGAR(8M707QY5GH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SPEARMINT(J7I2T6IV1N)
STARCH, CORN(O8232NY3SJ)
SUCRALOSE(96K6UQ3ZD4)
SUCROSE(C151H8M554)
SUGARCANE(81H2R5AOH3)
TALC(7SEV7J4R1U)

Drug Product Composition: Ethinylestradiol