Remeron (mirtazapine), marketed in the UK as Zispin SolTab, is a once-nightly tetracyclic antidepressant for major depressive disorder in adults, and FDA- and MHRA-licensed generic mirtazapine tablets now account for most of the volume moving through hospital and tender-desk orders.
M Care Exports supplies mirtazapine, a tetracyclic noradrenergic and specific serotonergic antidepressant (NaSSA) originated by Organon and sold as Remeron in the United States, taken once daily in the evening for major depressive disorder in adults. M Care is a merchant exporter: we source the originator brand and FDA- and MHRA-licensed generic mirtazapine tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Mirtazapine exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes mirtazapine tablets against buyer specification: brand (Remeron/Zispin) or generic, strength mix (15 mg, 30 mg, 45 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because mirtazapine's sedative effect is more pronounced at lower doses and lessens as the dose is titrated upward, we confirm the buyer's intended titration protocol and pack-size split before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Tetracyclic antidepressant; noradrenergic and specific serotonergic antidepressant (NaSSA), sourced and documented for export.
Mirtazapine is a tetracyclic NaSSA, structurally unrelated to SSRIs, that blocks central presynaptic alpha2-adrenergic autoreceptors and heteroreceptors, increasing noradrenaline and serotonin release, while its antagonism of H1 histamine and 5-HT2/5-HT3 receptors accounts for its sedative and antiemetic profile. It is dosed orally, taken once daily at night, and needs no reconstitution. The FDA and MHRA labels' sole licensed indication is major depressive disorder in adults; mirtazapine is not licensed for paediatric use, and destination-country labelling should be checked before a quote is finalised. Remeron/Zispin SolTab is supplied as 15 mg, 30 mg and 45 mg film-coated or orodispersible tablets, and an oral solution is also registered in some markets for patients who cannot swallow tablets.
Active ingredient
Mirtazapine. Tetracyclic antidepressant; noradrenergic and specific serotonergic antidepressant (NaSSA).
Forms and strengths
15 mg film-coated tablet; 30 mg film-coated tablet; 45 mg film-coated tablet.
Indications
Mirtazapine, a tetracyclic NaSSA antidepressant indicated for major depressive disorder in adults, taken once daily in the evening. Supplied as originator Remeron/Zispin SolTab and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Film-coated tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for mirtazapine are mainly hospital and community mental-health pharmacies managing adult patients with major depressive disorder, national and regional MoH tender desks running mental-health formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting mental-health access in markets where local registration is in place.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on mirtazapine.
Mirtazapine's sedative effect runs counter to most antidepressants: it is more pronounced at the 15 mg starting dose, because low-dose H1 blockade dominates, and tends to lessen as the dose is titrated to 30-45 mg once the noradrenergic effect strengthens, so dose reduction for daytime sedation can be counterproductive and should be flagged on any dispensing record. Dosing is once daily, preferably in the evening before sleep, with adjustments at one- to two-week intervals given a 20-40 hour half-life. Clearance falls by roughly 30 percent in hepatic impairment and 30-50 percent in moderate-to-severe renal impairment, so both should prompt a lower starting dose. Mirtazapine carries a rare but serious agranulocytosis risk: patients presenting with fever, sore throat, stomatitis or other infection signs should stop treatment and have a full blood count taken immediately. It also carries the class boxed warning on suicidal thinking and behaviour in children, adolescents and young adults during early treatment, and a minimum 14-day washout is required either side of an MAOI. No cold-chain handling or reconstitution is required; it is not a controlled substance in the US, and UK sources reviewed do not list it as a controlled drug either.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, mirtazapine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; UK SmPCs for the generic tablets state no special storage precautions, while the US label recommends storage at 25 degrees Celsius with excursions to 15-30 degrees permitted. Mirtazapine is not included on the current WHO Model List of Essential Medicines for depressive disorders; fluoxetine is the antidepressant WHO lists for adult and adolescent depression, so buyers should treat mirtazapine as a formulary-specific second-line agent rather than a WHO EML first-line antidepressant when building a tender specification. On the brand-versus-generic question, Remeron (US) and Zispin SolTab (UK, originated by Organon) were the originator products; FDA- and MHRA-approved generic mirtazapine tablets from multiple manufacturers have been registered for two decades and now account for the great majority of UK and US dispensing, with the current UK market on eMC dominated by generic film-coated, orodispersible and oral-solution lines rather than the branded product, so buyers genuinely have a brand-or-generic choice and generic mirtazapine is the practical default for volume tender orders. Because agranulocytosis is a recognised class-level risk, destination-market pharmacovigilance registration should name a local PV contact for adverse-event reporting rather than relying on the manufacturer's own PSUR cycle alone.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside mirtazapine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for mirtazapine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Mirtazapine supply, the specific questions.
Does a generic version of Remeron/Zispin exist?
Yes. FDA- and MHRA-approved generic mirtazapine tablets are registered and widely dispensed in the US and UK alongside the originator brands Remeron and Zispin SolTab, and generic lines now account for most volume on the UK market. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Remeron or Zispin SolTab to our market?
Yes, on an import basis. We source Remeron/Zispin through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds. Most orders we quote are for generic mirtazapine tablets, which are the lower-cost, more widely available option for tender-scale volume.
What strengths of mirtazapine tablets are available?
15 mg, 30 mg and 45 mg film-coated tablets, matching the Remeron/Zispin strengths, with orodispersible tablet and oral-solution formats also registered in some markets. Tell us your titration protocol and preferred formulation and we quote the strength split accordingly.
Why is mirtazapine sometimes more sedating at a lower dose?
Mirtazapine blocks histamine H1 receptors strongly at low doses, which drives sedation, while its noradrenergic effect, which counters sedation, becomes more prominent as the dose is titrated to 30-45 mg. This means reducing the dose to manage daytime drowsiness can be counterproductive, which is why prescribers and pharmacists flag it as a dosing nuance rather than a simple dose-response relationship.
What monitoring does mirtazapine require?
Mirtazapine carries a rare but serious agranulocytosis risk, so any patient presenting with fever, sore throat, stomatitis or other infection signs should stop treatment and have a full blood count taken immediately. It also carries the class boxed warning on suicidal thinking and behaviour in children, adolescents and young adults during early treatment, and clearance is reduced in hepatic or moderate-to-severe renal impairment, warranting a lower starting dose in those patients.
Is mirtazapine on the WHO Essential Medicines List?
No. Mirtazapine is not included on the current WHO Model List of Essential Medicines for depressive disorders; fluoxetine is the antidepressant WHO lists for adult and adolescent depression. Tender desks that specify mirtazapine typically do so for an existing formulary line or a patient already stabilised on it, rather than as a WHO EML first-line choice.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.