Fluvoxamine Extended-Release Capsules Suppliers & Bulk Manufacturers
Available Forms: Extended-Release Capsules
Available Strengths: Luvox CR
Reference Brands: Luvox(US); Fevarin(EU)
Category:
Antipsychotropic Drugs
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that increases serotonin levels in the brain, helping regulate mood and behavior. The extended-release formulation offers once-daily dosing. It is primarily used to treat obsessive-compulsive disorder (OCD) and social anxiety disorder (SAD) in adults, improving both intrusive thoughts and anxiety symptoms.
Fluvoxamine Extended-Release Capsules is available in Extended-Release Capsules
and strengths such as Luvox CR.
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, Fluvoxamine Extended-Release Capsules 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) |
Fluvoxamine Extended-Release Capsules 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.
Product Description:
In the United States, fluvoxamine extended-release (ER) capsules are FDA-approved for the treatment of obsessive-compulsive disorder (OCD) and social anxiety disorder (SAD). As a selective serotonin reuptake inhibitor (SSRI), it carries a Boxed Warning for increased risk of suicidal thoughts in adolescents and young adults. Regulatory compliance includes GMP standards, bioequivalence data for generics, and strict labeling and safety reporting. Ongoing pharmacovigilance is required through FDA’s FAERS system.
In the European Union, fluvoxamine is typically available in immediate-release tablet form, with the ER capsule less commonly approved. EU regulatory approval follows centralized or national procedures, with mandatory Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and comprehensive clinical data. For regulatory-ready sourcing, visit Pharmatradz.com.
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