
Quetiapine Fumarate Extended-Release Tablets (Xr) Suppliers & Bulk Manufacturers
Available Forms: Extended-Release tablets (XR)
Available Strengths: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
Reference Brands: US: Seroquel®, Seroquel XR®; EU: Seroquel®, Seroquel Prolong®, Quetiapine Teva®
Category: Antipsychotropic Drugs
Quetiapine Fumarate Extended-Release tablets (XR) is available in Extended-Release tablets (XR) and strengths such as 50 mg, 150 mg, 200 mg, 300 mg, 400 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, Quetiapine Fumarate Extended-Release tablets (XR) 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) |
Quetiapine Fumarate Extended-Release tablets (XR) 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: Quetiapine Fumarate XR tablets are FDA-approved in the USA for treating schizophrenia, bipolar disorder, and as an adjunct in major depressive disorder (MDD). Classified as an atypical antipsychotic, the drug mandates a Boxed Warning for increased suicidality in young adults and elderly dementia-related psychosis risks. Manufacturers must ensure GMP compliance, controlled labeling, and post-marketing safety reporting. In the EU, quetiapine XR is regulated via EMA or national authorizations, with stringent requirements for Risk Management Plans (RMPs), PSURs, and bioequivalence data. Explore dossier-ready, globally compliant quetiapine XR formulations at Pharmatradz.com.
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