Fluvoxamine Extended-Release Capsules bulk supplier for pharma manufacturers

Fluvoxamine Extended-Release Capsules Luvox CR Suppliers & Bulk Manufacturers

Available Forms: Extended-Release Capsules

Available Strengths: Luvox CR

Reference Brands: Luvox(US); Fevarin(EU)

Fluvoxamine extended-release capsules for once-daily bedtime dosing, an SSRI form registered in a limited number of markets. For licensed importers, distributors and hospital buyers who need a modified-release product.

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Product Description:

This page is for fluvoxamine in an extended-release capsule. The molecule is an SSRI that slows serotonin reuptake at nerve endings. The capsule holds coated beads that release the drug over many hours, so a single bedtime dose replaces the divided doses needed with ordinary tablets. In the United States the extended-release capsule has been marketed in 100 mg and 150 mg strengths. Many markets register only the immediate-release tablet.

In the United States the extended-release capsule is labelled for obsessive-compulsive disorder and social anxiety disorder in adults. It is taken once daily at bedtime, with or without food. The capsule must be swallowed whole, never opened, crushed or chewed, because damaging the beads defeats the release control. Interaction rules match the tablet, since fluvoxamine strongly inhibits CYP1A2 and CYP2C19; tizanidine, pimozide, thioridazine and MAO inhibitors are excluded. A boxed warning on suicidality in young people applies.

Sourcing notes. Check first that an extended-release fluvoxamine product is registered in your destination, since a modified-release generic needs its own approval. Bioequivalence for this kind of form is normally shown both fasting and fed, so ask for both studies plus multi-pH dissolution profiles. The dossier should be in CTD or ACTD format, with Zone IVb stability where the climate calls for it. Bottles with a desiccant or moisture-tight blisters are typical, at room temperature. Ask for a CoA per batch, the GMP certificate and a CoPP. Your enquiry should state the strength, pack count and registration route you plan to use.

Fluvoxamine Extended-Release Capsules — third party manufacturing & bulk supply

Fluvoxamine Extended-Release Capsules Luvox CR 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

Fluvoxamine Extended-Release Capsules is supplied as Extended-Release Capsules — 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 Fluvoxamine Extended-Release Capsules 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

Fluvoxamine Extended-Release Capsules is listed as Extended-Release Capsules in Luvox CR. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Fluvoxamine Extended-Release Capsules is referenced against Luvox(US); Fevarin(EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.