Vortioxetine Hydrobromide

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 27 USDMF, 3 JDMF, 13 EU WC, 10 KDMF, 9 NDC API, 42 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

67 Drugs in Development

67 Drugs in Development

INTERMEDIATES

19 Intermediate Suppliers

19 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

119 FDF Dossiers, 18 FDA Orange Book, 66 Europe, 6 Canada, 20 South Africa, 9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 2 DKSH, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Clariant, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 2 Kerry, 2 Keval Exports, 9 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 14 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

36 Fillers, Diluents & Binders, 17 Direct Compression, 17 Disintegrants & Superdisintegrants, 14 Chewable & Orodispersible Aids, 12 Taste Masking, 11 Thickeners and Stabilizers, 10 Lubricants & Glidants, 9 Granulation, 9 Co-Processed Excipients, 8 Coating Systems & Additives, 5 Parenteral, 4 Film Formers & Plasticizers, 3 Controlled & Modified Release, 2 Topical, 2 Coloring Agents, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Solubilizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 45 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Regulatory FDF Prices, 19 Annual Reports

MARKET PLACE

9 APIs, 4 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

80 US Patents, 8 US Exclusivities, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 Others

8 Others

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USFDA APPLICATION NUMBER - 204447 / DOSAGE - TABLET;ORAL - EQ 5MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VORTIOXETINE HYDROBROMIDE(UNII: TKS641KOAY) (VORTIOXETINE - UNII:3O2K1S3WQV)	VORTIOXETINE	20mg \| 15mg \| 10mg \| 5mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	Takeda Pharmaceuticals America, Inc.	REMEDYREPACK INC.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 4b0700c9 B417 4c3a B36f De461e125bd3 Applno 204447 Form Tablet Oral Dosage Eq 5mg Base - Drug Product Composition: Vortioxetine Hydrobromide