Daonil (glibenclamide), still marketed by Sanofi across several M Care markets, is a second-generation sulfonylurea that has sat on the WHO Essential Medicines List since 1982, and generic glibenclamide tablets, known in the US as glyburide, are a widely registered alternative to the originator brand.
M Care Exports is a merchant exporter: we source Daonil, the Sanofi originator brand, and generic glibenclamide tablets, known in the United States as glyburide, through licensed Indian distribution and manufacturing channels, then dispatch against buyer specification rather than from our own manufacturing. Glibenclamide is an oral sulfonylurea for type 2 diabetes and remains one of the most widely listed antidiabetics on national essential-medicines lists because of its low unit cost.
Glibenclamide exporter and bulk supplier from India.
For hospital, wholesaler and MoH tender-desk orders, M Care quotes glibenclamide tablets against buyer specification: brand (Daonil) or generic, strength mix (2.5 mg, 5 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because glibenclamide carries a higher hypoglycaemia risk than newer sulfonylureas, particularly in elderly or renally impaired patients, we confirm the buyer's target patient population before dispatch, then align CTD 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.
Second-generation sulfonylurea; ATP-sensitive potassium (KATP) channel blocker at the SUR1 subunit, sourced and documented for export.
Glibenclamide is a second-generation sulfonylurea that binds the SUR1 subunit of the pancreatic beta-cell ATP-sensitive potassium channel, closing the channel and triggering insulin release independent of the prevailing blood glucose level, which is why hypoglycaemia is its defining risk. It is dosed orally, not injected, and needs no reconstitution or cold-chain handling. The FDA label's flagship indication is as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus; it is contraindicated in type 1 diabetes, diabetic ketoacidosis and in patients taking bosentan. Daonil and generic glibenclamide are supplied as 2.5 mg and 5 mg tablets, usually taken with breakfast or the first main meal, and the US label carries a warning on increased cardiovascular mortality relative to diet alone, drawn from the University Group Diabetes Program study.
Active ingredient
Glibenclamide. Second-generation sulfonylurea; ATP-sensitive potassium (KATP) channel blocker at the SUR1 subunit.
Forms and strengths
2.5 mg tablet; 5 mg tablet.
Indications
Glibenclamide, a second-generation sulfonylurea indicated as an adjunct to diet and exercise for glycaemic control in adults with type 2 diabetes mellitus. Supplied as originator Daonil and licensed generic tablets, known in the US as glyburide, from Indian channels to regulated and semi-regulated markets outside India.
Administration
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 for glibenclamide are mainly national and regional MoH tender desks running type 2 diabetes formulary lists, hospital and primary-care pharmacies managing established diabetic populations, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting diabetes-care access in markets where glibenclamide remains the lowest-cost oral option on the formulary.
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 glibenclamide.
Glibenclamide's usual starting dose is 2.5 to 5 mg once daily with the first main meal, titrated cautiously toward a practical ceiling of 20 mg daily, and patients who may be more sensitive to hypoglycaemic agents should start at 1.25 mg. Elderly patients and those with renal or hepatic impairment clear the drug and its active metabolites more slowly, so hypoglycaemia risk rises accordingly, and glibenclamide's hypoglycaemia rate runs higher than shorter-acting sulfonylureas such as gliclazide. The US label carries a warning on increased cardiovascular mortality relative to diet alone, drawn from the University Group Diabetes Program study, and glibenclamide is contraindicated with bosentan because of a hepatotoxicity interaction. In pregnancy, insulin is generally preferred and sulfonylurea therapy should be discontinued once pregnancy is detected. As a solid oral tablet, glibenclamide needs no reconstitution and travels on standard ambient logistics, not cold chain, which simplifies dispatch compared with the insulins it is often tendered alongside.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, glibenclamide travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for insulins and biologicals. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or country-specific dossier support so the buyer's own regulator can register the product. Glibenclamide has sat on the WHO Model List of Essential Medicines since 1982, under the hypoglycaemic agents section for type 2 diabetes, and a Ugandan budget-impact study found it the least costly sulfonylurea on that country's essential medicines list, delivering meaningful government savings when used in place of glimepiride or gliclazide, while flagging a higher hypoglycaemia rate that leads some formularies to reserve it for patients under 65 and substitute glimepiride above that age. On the brand-versus-generic question, Daonil and Semi-Daonil remain marketed Sanofi products in several M Care markets, generic glibenclamide (known in the US as glyburide) is FDA-approved and widely registered elsewhere, and of the two original US brand names, Micronase was withdrawn from the market (per an FDA determination that this was not for safety or effectiveness reasons) while Diabeta remains an FDA-listed Sanofi Aventis US brand alongside generic glyburide; buyers should specify brand or generic against their tender requirement.
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 glibenclamide.
Dapagliflozin
Another diabetes & endocrine line ordered on the same formularies.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Dulaglutide
Another diabetes & endocrine line ordered on the same formularies.
All diabetes & endocrine
The full category listing for procurement desks.
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 glibenclamide.
- 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.
Glibenclamide supply, the specific questions.
Is glibenclamide the same drug as glyburide?
Yes. Glibenclamide is the international non-proprietary name and glyburide is the same molecule under its US Adopted Name. Both refer to the identical sulfonylurea, and M Care can supply against either name on a purchase order or tender specification.
Does a generic version of Daonil exist?
Yes. Generic glibenclamide, known in the US as glyburide, is FDA-approved and widely registered outside the US too. Of the two original US brand names, Micronase was withdrawn from the market, while Diabeta remains an approved Sanofi brand alongside generic glyburide. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Why is glibenclamide still on so many essential-medicines lists?
It has been on the WHO Model List of Essential Medicines since 1982, under hypoglycaemic agents for type 2 diabetes, and its low unit cost keeps it on most national lists even where newer sulfonylureas are also registered. Ministries of health weighing cost against hypoglycaemia risk often specify glibenclamide as the budget-line agent and a newer sulfonylurea as the clinical alternative for higher-risk patients.
Is glibenclamide suitable for elderly patients?
It carries a higher hypoglycaemia risk than shorter-acting sulfonylureas, and that risk is more pronounced in patients over 65 and those with renal or hepatic impairment, so many prescribers start such patients at a reduced 1.25 mg dose or move to an alternative agent such as glimepiride. M Care flags this dosing nuance to buyers sourcing for elderly-heavy formularies.
Does glibenclamide need cold-chain shipping?
No. It is a solid oral tablet stored at controlled room temperature, and it travels on M Care's standard ambient logistics rather than the cold-chain lanes reserved for insulins and biologicals.
What strengths and pack formats can M Care supply?
2.5 mg and 5 mg tablets, matching the Daonil strengths, in blister packs with destination-language patient information leaflets. Tell us your target patient population and tender strength mix and we quote accordingly.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.