Vortioxetine Film-Coated Tablets bulk supplier for pharma manufacturers

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.

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📘 Sourcing Guide
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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.

Frequently Asked Questions

Yes, Vortioxetine Film-Coated Tablets is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Vortioxetine Film-Coated Tablets is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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