Mirtazapine Tablets/Odt Suppliers & Bulk Manufacturers
Available Forms: Tablets/ODT
Available Strengths: 15 mg, 30 mg, 45 mg
Reference Brands: US: Remeron®, Remeron SolTab®; EU: Zispin®, Mirtazapine Teva®, Mirtazon®, Espran®
Category:
Antipsychotropic Drugs
Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) that enhances norepinephrine and serotonin neurotransmission by blocking central presynaptic α2-adrenergic receptors. It is used to treat major depressive disorder (MDD), offering fast onset of action, improved sleep, and appetite stimulation. ODT formulation improves compliance in patients with swallowing difficulties.
Mirtazapine Tablets/ODT is available in Tablets/ODT
and strengths such as 15 mg, 30 mg, 45 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, Mirtazapine Tablets/ODT 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) |
Mirtazapine Tablets/ODT 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:
Mirtazapine Tablets and Orally Disintegrating Tablets (ODT) are FDA-approved in the USA for the treatment of major depressive disorder (MDD). As a noradrenergic and specific serotonergic antidepressant (NaSSA), mirtazapine requires a Boxed Warning for the risk of suicidal thoughts in young adults. Regulatory compliance includes GMP, labeling accuracy, and robust post-marketing safety reporting. In the European Union, Mirtazapine is approved under national procedures or via mutual recognition, with strict guidelines for Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs). Explore global dossiers and reliable sources of Mirtazapine at Pharmatradz.com.
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