Duloxetine is chemically unstable in stomach acid, so every commercial tablet or capsule is built as a delayed-release, enteric-coated dosage form, and M Care Exports supplies both from WHO-GMP certified Indian manufacturers.
Duloxetine hydrochloride breaks down rapidly at low gastric pH, which is why no plain immediate-release version of this molecule has ever reached commercial markets. Every duloxetine product, tablet or capsule, is manufactured as an enteric-coated, delayed-release formulation designed to survive the stomach intact before releasing the active substance in the intestine. M Care Exports supplies 32 duloxetine lines across oral tablets and capsules, sourced from WHO-GMP certified Indian manufacturers, for regulatory affairs teams and procurement desks who need to verify that constraint before it reaches their dossier.
Duloxetine exporter and bulk supplier from India.
Export documentation for duloxetine includes the certificate of analysis, certificate of pharmaceutical product, manufacturing site GMP certificate, and stability data supporting the enteric coating's acid resistance and delayed-release dissolution profile, since these are the parameters a receiving regulator checks first for this molecule. Tablets and capsules are packed to protect coating integrity in transit, in blister strips or HDPE containers with desiccant where moisture exposure is a transit risk, and shipments are accompanied by a packing list, commercial invoice, certificate of origin and, where the destination requires it, a free sale certificate for the manufacturing site. M Care coordinates with the sourcing manufacturer on batch-specific documentation so that importers receive paperwork matched to the actual strength and pack landing at their port, rather than generic specification sheets.
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.
Serotonin-norepinephrine reuptake inhibitor (SNRI), sourced and documented for export.
Duloxetine's defining manufacturing fact is that it cannot survive as a standard immediate-release tablet: the hydrochloride salt degrades in acidic conditions, so formulators enteric-coat every unit, whether that unit is a tablet or a capsule filled with coated pellets, to protect the drug through the stomach before it dissolves in the small intestine. Clinically, duloxetine is a serotonin-norepinephrine reuptake inhibitor used for major depressive disorder, generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and certain chronic musculoskeletal pain conditions such as osteoarthritis and chronic low back pain. It carries a boxed warning on suicidal thinking in younger patients, contraindications with monoamine oxidase inhibitors, and cautions around hepatic impairment and abrupt discontinuation. M Care's catalogue holds 32 duloxetine lines across five strengths, all oral tablets or capsules, none injectable or liquid, consistent with what the molecule's chemistry actually permits.
Active ingredient
Duloxetine hydrochloride. Serotonin-norepinephrine reuptake inhibitor (SNRI).
Forms and strengths
10 mg; 20 mg; 30 mg; 40 mg; 60 mg.
Indications
Duloxetine is a serotonin-norepinephrine reuptake inhibitor indicated for major depressive disorder, generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and certain chronic musculoskeletal pain conditions such as osteoarthritis and chronic low back pain. Because the hydrochloride salt is unstable at low gastric pH, it is manufactured exclusively as an enteric-coated, delayed-release tablet or as a capsule containing enteric-coated pellets, never as an immediate-release, injectable or liquid oral form.
Administration
Oral. Enteric-coated, delayed-release tablet and capsule.
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.
Duloxetine moves through regulatory affairs teams at generic importers, hospital and retail pharmacy chains, and tender desks preparing CNS formulary submissions in the UK, EU, Gulf Cooperation Council states, African importing markets, Latin America and Southeast Asia. Buyers in these regions typically hold a national marketing authorisation or are assembling a dossier for one, and they order duloxetine as part of a broader antidepressant or neuropathic pain portfolio rather than as a single-line purchase. CIS-region distributors and licensed importers preparing local registration files also request duloxetine alongside other SNRI and SSRI lines. Because every unit is enteric-coated, buyers across all these markets ask the same first question: whether the coating and pellet integrity have stability data behind them, which shapes how M Care packages and documents each shipment.
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 duloxetine.
A reviewing pharmacist checks first that the enteric coating and, for capsules, the pellet fill inside, are intact and validated against acid-resistance and delayed-release dissolution specifications, since duloxetine's entire formulation exists to solve one stability problem and any coating defect undermines both bioavailability and gastrointestinal tolerability. Interaction screening focuses on strong CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin, which raise duloxetine plasma levels, and on concomitant serotonergic agents and monoamine oxidase inhibitors, which are contraindicated due to serotonin syndrome risk. Hepatic function and alcohol use history are reviewed given the risk of markedly increased drug exposure in hepatic insufficiency and reports of hepatotoxicity, and renal function is checked before use in severe impairment (creatinine clearance below 30 mL/min). Reviewers also confirm the product is not indicated for abrupt discontinuation without a taper, given documented discontinuation symptoms, and that units have not been repackaged in a way that would crush, split or expose the coated pellets, since duloxetine cannot be compounded or dose-adjusted by altering the dosage form itself.
The documentation pack a regulator actually asks for.
M Care's duloxetine documentation pack covers the certificate of analysis per batch, manufacturing site GMP certificate, certificate of pharmaceutical product where required by the destination regulator, and stability data specific to the enteric-coated dosage form, since delayed-release dissolution performance is the parameter most import regulators query first for this molecule. Sourcing manufacturers maintain WHO-GMP certification, and M Care itself holds ISO 9001:2015 certification and a CDSCO export licence, and does not claim WHO-GMP or WHO-PQ status of its own, as it is a merchant-exporter rather than a manufacturing site. Buyers preparing a registration dossier receive the drug master file reference or open-part data the manufacturer provides, along with impurity and degradation profiles relevant to an acid-labile active substance. Where a destination market requires a certificate of pharmaceutical product or a free sale certificate, M Care coordinates directly with the manufacturing site to obtain the version matching the specific strength and batch being shipped, rather than a generic template document.
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.
FDA boxed warning: increased risk of suicidal thinking and behaviour in children, adolescents and young adults up to age 24, consistent with other antidepressants of this class
Contraindicated with monoamine oxidase inhibitors (MAOIs) due to risk of serotonin syndrome
Not recommended in patients with hepatic insufficiency, due to markedly increased drug exposure in this population
Not recommended with substantial alcohol use; duloxetine has been associated with reports of hepatotoxicity including rare hepatic failure
Not recommended in severe renal impairment (creatinine clearance below 30 mL/min)
Abrupt discontinuation associated with discontinuation symptoms; dose tapering recommended under clinical supervision
Adjacent lines procurement desks order alongside duloxetine.
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 duloxetine.
- 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.
Duloxetine supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturing site, and does not hold WHO-GMP or WHO-PQ certification itself. Its own credentials are ISO 9001:2015 and a CDSCO export licence. Duloxetine tablets and capsules are sourced from WHO-GMP certified Indian manufacturers, and their certification documents are supplied with each shipment.
Why are all duloxetine products enteric-coated or delayed-release rather than immediate-release?
Duloxetine hydrochloride degrades rapidly in acidic conditions, so no immediate-release oral formulation has ever been commercially viable. Every tablet is enteric-coated and every capsule contains enteric-coated pellets, both designed to survive the stomach intact and release the active substance in the small intestine.
Can duloxetine tablets or capsules be split, crushed, or opened before dispensing?
No. Splitting a tablet or opening a capsule breaks the enteric coating that protects duloxetine from stomach acid, which can reduce bioavailability and increase gastrointestinal irritation. The dosage form must reach the patient intact, so dose adjustment is made by strength selection, not by altering the unit.
What is the main safety warning associated with duloxetine?
Duloxetine carries a boxed warning for increased risk of suicidal thinking and behaviour in children, adolescents and young adults up to age 24, consistent with other antidepressants of its class. It is also contraindicated with monoamine oxidase inhibitors and carries cautions around hepatic impairment and abrupt discontinuation.
Which strengths does M Care supply for duloxetine?
M Care supplies duloxetine oral tablets and capsules in 10mg, 20mg, 30mg, 40mg and 60mg strengths across 32 catalogue lines, all enteric-coated or delayed-release formulations consistent with the molecule's stability profile.
Does M Care supply duloxetine as an injection or oral liquid?
No. M Care supplies only oral tablets and capsules. Duloxetine is not commercially marketed as an injectable or oral liquid product; it is manufactured and available in the export market as enteric-coated, delayed-release tablets and capsules only, which is what M Care's 32-line catalogue reflects.
What documentation does M Care provide for a regulatory submission dossier?
M Care coordinates batch-specific certificates of analysis, manufacturing site GMP certificates, certificates of pharmaceutical product where required, and stability data covering the enteric coating's dissolution performance. These are matched to the specific strength and batch being shipped rather than issued as generic templates.
Which regions does M Care export duloxetine to?
M Care supplies licensed importers, hospital and retail pharmacy chains, and tender desks across the UK, EU, Gulf Cooperation Council states, African markets, Latin America, Southeast Asia and CIS countries. India is the country of manufacture only and is not a served market.
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.
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.