Escitalopram is the single S-enantiomer isolated from racemic citalopram, and that stereochemistry, not a new dose, is what its export dossier has to prove.
Escitalopram oxalate is not simply a stronger citalopram. It is the purified S-enantiomer separated from the racemic mixture, a distinct drug substance with its own enantiomeric purity specification and its own regulatory file. M Care Exports supplies escitalopram oxalate tablets in 5mg, 10mg, 15mg and 20mg strengths, sourced from WHO-GMP certified Indian manufacturers, to regulatory affairs and procurement teams who need that distinction documented, not assumed.
Escitalopram exporter and bulk supplier from India.
Export consignments ship with the certificate of analysis showing enantiomeric purity by chiral HPLC (not just an assay by weight), the certificate of pharmaceutical product, batch manufacturing record extracts and stability data on request, alongside M Care's CDSCO export licence and ISO 9001:2015 certificate. Tablets are packed in blister strips inside cartons designed for ambient air and sea freight; no cold chain is required. Because escitalopram oxalate is a distinct pharmacopoeial entity from citalopram hydrobromide, documentation is drafted against the correct monograph and INN for each shipment so it is not queried at destination customs or by the receiving regulator as a mismatched drug substance.
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.
Selective serotonin reuptake inhibitor (SSRI), single enantiomer of citalopram, sourced and documented for export.
Escitalopram is the single S-enantiomer isolated from racemic citalopram: roughly 30-fold more active at the serotonin transporter than the R-enantiomer it was separated from, and formulated as escitalopram oxalate. That separation is why pharmacopoeial monographs carry a specific limit on residual R-enantiomer as a chiral impurity, checked by chiral HPLC rather than an ordinary assay. Clinically it is an SSRI approved for major depressive disorder and generalised anxiety disorder, with onset over several weeks and a discontinuation syndrome on abrupt withdrawal. Dosing carries a ceiling set on cardiac grounds: most regulators cap the adult dose at 20mg per day and halve it for patients over 65, for hepatic impairment and for known CYP2C19 poor metabolisers, which is exactly the strength ladder M Care stocks.
Active ingredient
Escitalopram oxalate (expressed as escitalopram base). Selective serotonin reuptake inhibitor (SSRI), single enantiomer of citalopram.
Forms and strengths
5 mg; 10 mg; 15 mg; 20 mg.
Indications
Escitalopram oxalate is the single S-enantiomer of racemic citalopram, an SSRI antidepressant supplied by M Care Exports as oral tablets sourced from WHO-GMP certified Indian manufacturers for regulated export markets.
Administration
Oral. Oral 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 are regulatory affairs teams, hospital and government tender desks, and licensed importers across the UK, EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and the CIS who stock escitalopram as a distinct SKU from citalopram rather than a dose variant of it. Hospital and institutional formularies that list generalised anxiety disorder alongside depression as an indication are a natural fit, as are tender desks replacing a citalopram-only line with an escitalopram option once local pricing allows it. India is the country of manufacture only; it is not a served market for this listing.
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 escitalopram.
A reviewing pharmacist checks that the certificate of analysis reports enantiomeric purity by a validated chiral method, not only a non-chiral assay, since a racemisation or synthesis shortfall would not show up any other way; both the European Pharmacopoeia and USP monographs set a defined limit on residual R-enantiomer as a chiral impurity, and buyers should confirm the batch result against whichever monograph their own regulator specifies. The strength ladder matters clinically: 20mg per day is the ceiling for most adults, and 10mg is the ceiling for patients over 65, for hepatic impairment and for documented CYP2C19 poor metabolisers, because escitalopram exposure and dose-dependent QT prolongation both track CYP2C19 activity. Escitalopram is metabolised primarily by CYP2C19 with minor CYP3A4 and CYP2D6 contribution, so interaction screening against CYP2C19 inhibitors on a buyer's own formulary is standard practice, not an optional check, and the same screening should flag other serotonergic or QT-prolonging agents before a purchase order is finalised.
The documentation pack a regulator actually asks for.
The documentation pack covers CDSCO export licence and ISO 9001:2015 certification for M Care as exporter, plus manufacturer-level WHO-GMP certification, certificate of pharmaceutical product, GMP certificate and batch-specific certificate of analysis sourced from the manufacturing site. The certificate of analysis for escitalopram oxalate should report enantiomeric purity by chiral HPLC against the applicable pharmacopoeial monograph (Ph. Eur. or USP as specified by the buyer), separately from the related-substances assay, since this is the parameter that distinguishes escitalopram from racemic citalopram at the analytical level.M Care does not hold WHO-GMP or WHO-PQ certification itself and does not claim to.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Prescription-only medicine; buyers must confirm the equivalent prescription-only or controlled-medicine status of escitalopram in the destination country before import.
Adult dose ceiling of 20mg per day, reduced to 10mg per day for patients over 65, hepatic impairment, or known CYP2C19 poor metabolisers, reflecting dose-dependent QT interval prolongation risk (MHRA and EMA labelling).
Contraindicated with other QT-prolonging medicines and in patients with congenital long QT syndrome or known pre-existing QT prolongation.
Boxed warning in US labelling for increased suicidal thinking and behaviour in children, adolescents and young adults; not indicated for pediatric use below the age approved in the destination market.
Discontinuation syndrome reported on abrupt withdrawal after sustained use.
M Care Exports is a merchant-exporter and does not hold WHO-GMP or WHO-PQ certification; documentation is supplied by the sourcing manufacturer.
Adjacent lines procurement desks order alongside escitalopram.
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 escitalopram.
- 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.
Escitalopram supply, the specific questions.
Is escitalopram the same drug substance as citalopram, just at a different dose?
No. Escitalopram is the isolated S-enantiomer of racemic citalopram, formulated as escitalopram oxalate, and is registered as a separate INN and pharmacopoeial entity. A certificate of analysis for escitalopram must report enantiomeric purity by chiral HPLC against its own monograph; a citalopram certificate of analysis does not satisfy an escitalopram order and the two should never be substituted on a purchase order.
What is the maximum daily dose, and why does it matter for the strengths you stock?
Most regulators cap the adult dose at 20mg per day and reduce it to 10mg for patients over 65, for hepatic impairment and for known CYP2C19 poor metabolisers, reflecting dose-dependent QT prolongation risk. M Care's 5mg, 10mg, 15mg and 20mg tablet strengths cover that full titration range; buyers building a formulary line should stock the lower strengths, not just 20mg, to support the reduced-dose populations.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Escitalopram oxalate tablets are sourced from WHO-GMP certified Indian manufacturing sites, and the manufacturer's own WHO-GMP certificate and certificate of pharmaceutical product are supplied with each consignment. M Care's own credentials are ISO 9001:2015 and a CDSCO export licence.
What dosage forms of escitalopram does M Care actually supply?
Oral tablets only, in escitalopram base equivalent strengths of 5mg, 10mg, 15mg and 20mg, formulated as escitalopram oxalate. M Care does not currently supply escitalopram capsules, oral suspension or any injectable, topical, ophthalmic or inhaled form; buyers requiring those should confirm availability separately rather than assume this catalogue covers them.
What documentation should accompany an escitalopram consignment for regulatory review?
A batch-specific certificate of analysis (with enantiomeric purity by chiral HPLC), the manufacturer's WHO-GMP certificate, certificate of pharmaceutical product, and M Care's CDSCO export licence and ISO 9001:2015 certificate. Stability data and a certificate of free sale can be supplied on request where the destination regulator asks for them.
Are there known drug interactions that a buyer's formulary team should flag?
Escitalopram is metabolised mainly by CYP2C19, with minor CYP3A4 and CYP2D6 contribution, and its dose ceiling is reduced when co-prescribed with CYP2C19 inhibitors because of dose-dependent QT prolongation risk. It is contraindicated with other QT-prolonging medicines and in patients with congenital long QT syndrome; this should be checked against the buyer's own formulary, not assumed from the label alone.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
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