Vortioxetine Film-Coated Tablets Suppliers & Bulk Manufacturers
Available Forms: Film-Coated Tablets
Available Strengths: 5 mg, 10 mg, 15 mg(EU only), 20 mg
Reference Brands: Trintellix®(US); Brintellix®(EU)
Category:
Antipsychotropic Drugs
Vortioxetine is a serotonin modulator and stimulator that inhibits serotonin reuptake and acts on multiple 5-HT receptors. It is approved for treating major depressive disorder (MDD) in adults, improving both mood and cognitive symptoms. Vortioxetine offers favourable tolerability with minimal sexual side effects and weight gain compared to other antidepressants.
Vortioxetine Film-Coated Tablets is available in Film-Coated Tablets
and strengths such as 5 mg, 10 mg, 15 mg(EU only), 20 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Vortioxetine Film-Coated Tablets is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Vortioxetine Film-Coated Tablets can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Vortioxetine film-coated tablets are FDA-approved in the United States for the treatment of major depressive disorder (MDD) in adults. As a serotonin modulator and stimulator, vortioxetine's approval includes strict labeling for suicidal thoughts and behaviors, particularly in young adults. Regulatory requirements in the U.S. include GMP-compliant manufacturing, bioequivalence standards for generics, and ongoing post-marketing surveillance.
In the European Union, vortioxetine is authorized under the centralized EMA procedure for the treatment of MDD. EU regulations require a comprehensive Risk Management Plan (RMP), safety monitoring, and periodic safety update reports (PSURs). For dossier-ready sourcing and global supply options, visit Pharmatradz.com.
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