Quetiapine Fumarate Extended-Release tablets (XR) bulk supplier for pharma manufacturers

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.

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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.

Frequently Asked Questions

Yes, Quetiapine Fumarate Extended-Release tablets (XR) 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, Quetiapine Fumarate Extended-Release tablets (XR) 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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