WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Zoloft and Lustral (sertraline) are SSRI antidepressants for major depression and anxiety-related disorders, supplied as 25, 50 and 100 mg tablets and, in some markets, an oral concentrate, all stored at ambient temperature.

M Care Exports supplies Zoloft (sertraline), distributed in the US by Viatris Specialty LLC, and Lustral (sertraline), the Viatris brand in the UK, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for sertraline 25, 50 or 100 mg tablets, send the destination, the strength, the pack and the quantity, and we quote per destination.

Lustral 50 mg sertraline tablets pack
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Sertraline exporter and bulk supplier from India.

"We need a partner for sertraline" is a typical psychiatry formulary or MoH tender enquiry. M Care is a merchant-exporter: we supply originator or regulator-registered brands and Indian-made lines, and we confirm which one your destination's registration route accepts before quoting. The US Zoloft label lists 25, 50 and 100 mg film-coated tablets and a 20 mg/mL oral solution supplied as a concentrate. The UK emc lists Lustral as 50 mg and 100 mg film-coated tablets, with generic sertraline tablets and oral concentrates listed by other companies. Indian-made lines on our roster include Serta, Serlift and Zosert in 25, 50 and 100 mg tablets, and Daxid in 50 mg. We do not state that any of these Indian-made lines is registered in a given destination. Sertraline needs no cold chain, which keeps freight simple. Buyers often list it beside escitalopram, duloxetine, mirtazapine and amitriptyline.

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.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Selective serotonin reuptake inhibitor (SSRI), antidepressant, sourced and documented for export.

Sertraline is a selective serotonin reuptake inhibitor (SSRI). The US Zoloft label (DailyMed, distributed by Viatris Specialty LLC, revised August 2023) lists 25 mg (light green), 50 mg (light blue) and 100 mg (light yellow) film-coated tablets, and a 20 mg/mL oral solution (listed on DailyMed as solution, concentrate) with 12% alcohol in a 60 mL bottle with a calibrated dropper. The concentrate must be diluted: the dose is mixed with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice only and taken immediately. The US indications are major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder. The UK emc SmPCs for Lustral (Viatris Products Limited, first authorised 23 June 2009) list a different set: major depressive episodes and prevention of recurrence, panic disorder with or without agoraphobia, OCD in adults and in patients aged 6 to 17, social anxiety disorder and PTSD. The UK Lustral SmPCs list no premenstrual dysphoric disorder indication. For the EU, the EMA referral page for Zoloft records an Article 30 review to harmonise the prescribing information, with a European Commission decision dated 27 March 2009. That page lists the other trade names covered by the review as Tresleen, Serlain, Lustral, Tatig and Besitran.

Active ingredient

Sertraline (as hydrochloride). Selective serotonin reuptake inhibitor (SSRI), antidepressant.

Forms and strengths

25 mg film-coated tablet; 50 mg film-coated tablet; 100 mg film-coated tablet; 20 mg/mL oral concentrate, 60 mL bottle (US Zoloft label).

Indications

Sertraline is an SSRI antidepressant used for major depression and several anxiety-related disorders, with indications that differ between the US and UK labels.

Administration

Oral. Film-coated tablet and oral concentrate.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers are hospital pharmacists in psychiatry and mental health units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for sertraline 50 mg tablets for a hospital formulary" or "We need a partner for Zoloft 100 mg for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. M Care supplies both originator or regulator-registered brands and Indian-made lines, and does not state that any Indian-made line is registered in a destination unless that destination's regulator confirms it.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on sertraline.

Check which label your destination follows, because the market texts differ. The US label starts major depression at 50 mg a day, OCD at 50 mg a day for ages 13 and over (25 mg for ages 6 to 12), and panic disorder, PTSD and social anxiety disorder at 25 mg a day. The UK SmPC gives 50 mg a day for depression and OCD, and 25 mg for one week, then 50 mg, for panic, PTSD and social anxiety. Both texts allow titration up to 200 mg a day for these indications, with dose changes no more often than once a week. The US label carries a boxed warning on suicidal thoughts and behaviours in paediatric and young adult patients. The UK SmPC says not to use sertraline under 18 except for OCD in ages 6 to 17. Contraindications in both texts include MAOIs (the UK SmPC requires 14 days after stopping an irreversible MAOI) and pimozide. The oral concentrate is also contraindicated with disulfiram because of its alcohol content. Both texts warn of serotonin syndrome, bleeding and QTc prolongation, and both advise tapering gradually on discontinuation. The US label stores tablets at 20 to 25 °C. The UK Lustral SmPC says do not store above 30 °C, with a 5-year shelf life.

Regulatory & quality

The documentation pack a regulator actually asks for.

Sertraline is an ambient-temperature product, so no cold chain applies on the texts we read. The US Zoloft label shows storage at 20 to 25 °C, with excursions permitted to 15 to 30 °C. The UK Lustral SmPCs state do not store above 30 °C and a 5-year shelf life. The UK Rosemont 20 mg/mL concentrate has a 24-month shelf life and should be discarded 60 days after first opening. Generic sertraline is regulator-listed in the US (DailyMed lists many generic sertraline labels) and in the UK (the emc lists generic tablets from several companies, including 25 mg strengths, plus oral concentrates). For the EU, we cite only the EMA Zoloft referral page and do not state the generic position. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state the source and quality status of each line before quoting, and make no manufacturing or WHO claim for M Care itself.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for sertraline.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Sertraline supply, the specific questions.

What is the Zoloft generic name?

The generic name is sertraline, supplied as sertraline hydrochloride. Zoloft is the US brand, and the current DailyMed label names Viatris Specialty LLC as distributor. In the UK the same molecule is sold under the brand Lustral, and the emc lists Viatris Products Limited as its holder. M Care Exports supplies the molecule as originator or regulator-registered brands and as Indian-made lines such as Serta, Serlift and Zosert, quoted per destination.

What does Zoloft 50 mg mean, and what is the dose?

Zoloft 50 mg is one strength of sertraline film-coated tablet, light blue in the US label. The UK Lustral 50 mg tablet is white, capsule-shaped and scored. Dosing depends on the indication and the label: both the US label and the UK SmPC start depression at 50 mg a day and allow titration up to 200 mg a day, with dose changes no more often than once a week. Treat the local label as the reference, and send us the strength, pack and quantity you need.

Can I buy Zoloft in Dubai, and what is the UAE route?

The UAE route depends on the destination regulator. Product registration in the UAE sits with the Emirates Drug Establishment (EDE). Whether a given sertraline brand or Indian-made line is registered there is something M Care Exports confirms per enquiry, and we do not state that any line is registered in the UAE. Send the brand or strength you need and your licensed importer details.

What sets the landed price of Zoloft for an importer in Nigeria?

We do not publish prices. The landed cost depends on whether you want the originator Zoloft or Lustral, a regulator-registered generic or an Indian-made line, the strength (25, 50 or 100 mg), the pack size, the quantity, the registration route with NAFDAC, and Incoterms. No cold chain applies on the texts we read, which keeps freight simpler. M Care Exports quotes per destination once we have the strength, pack and quantity.

What is Zoloft used for?

The US label lists major depressive disorder, OCD, panic disorder, PTSD, social anxiety disorder and premenstrual dysphoric disorder. The UK SmPCs list major depressive episodes and prevention of recurrence, panic disorder, OCD in adults and ages 6 to 17, social anxiety disorder and PTSD, and no premenstrual dysphoric disorder. The US label carries a boxed warning on suicidal thoughts and behaviours in paediatric and young adult patients. Any use not on the local label is not a labelled indication, and we do not suggest it.

Is there a generic Zoloft tablet, and what do you supply?

Yes, generic sertraline is listed by regulators in the two markets we checked. DailyMed lists many generic sertraline labels in the US, and the emc lists generic sertraline tablets from several UK companies, including 25 mg tablets. For the EU we cite only the EMA Zoloft referral page, which records an Article 30 review to harmonise prescribing information. M Care Exports supplies the originator or regulator-registered brand and Indian-made lines, and confirms per enquiry which one your destination's registration route accepts.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.

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.

Sertraline enquiry

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.

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