
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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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