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Quetiapine Fumarate Extended-Release 50 mg tablets (XR) bulk supplier for pharma manufacturers

Quetiapine Fumarate Extended-Release 50 mg 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®

Category: Antipsychotropic Drugs

Quetiapine XR is an atypical antipsychotic that works by modulating dopamine and serotonin receptors in the brain, helping to stabilize mood and reduce psychotic symptoms. It is used for schizophrenia, bipolar disorder, and as an adjunct in major depressive disorder, offering controlled, once-daily dosing for improved symptom management.

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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.

Quetiapine Fumarate Extended-Release 50 mg Tablets (XR) — third party manufacturing & bulk supply

Quetiapine Fumarate Extended-Release 50 mg Tablets (XR) is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Quetiapine Fumarate Extended-Release 50 mg Tablets (XR) is supplied as Extended-Release tablets (XR) — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Quetiapine Fumarate Extended-Release 50 mg Tablets (XR) listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Quetiapine Fumarate is an atypical antipsychotic medication used to treat psychiatric conditions such as schizophrenia, bipolar disorder (mania and depression), and major depressive disorder (as an adjunct therapy). It helps manage symptoms such as hallucinations, delusions, mood swings, and agitation.

Quetiapine Fumarate is the fumarate salt form of Quetiapine, a dibenzothiazepine derivative that works by modulating neurotransmitters in the brain, including serotonin and dopamine, to restore chemical balance and improve mood and thought processes.

It is marketed under trade names such as Seroquel, Ketipinor, Quetapine XR, and other regional generics.

More than one company makes it, including manufacturers in India. Share your market and we will find licensed makers whose documents fit.

The generic name is Quetiapine Fumarate.

Common brand names include Seroquel, Ketipinor, and Quetapine XR.

It is manufactured globally, including in the USA, Europe, India, and LATAM, by both innovator and generic pharmaceutical companies.

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