Glimepiride, Indian WHO-GMP supply for once-daily type 2 diabetes therapy
Glimepiride is the sulfonylurea most often specified by name when a formulary wants once-daily dosing without stepping up to a DPP-4 inhibitor or GLP-1 agent, and it is rarely ordered as a single SKU: strength ladders from 1 mg to 4 mg (occasionally to 8 mg) sit alongside metformin fixed-dose combinations on the same purchase order. M Care sources glimepiride tablets and glimepiride-metformin FDCs from WHO-GMP certified Indian manufacturers for hospital procurement, licensed importers, wholesalers and tender desks across the Gulf, Africa, UK/EU, Southeast Asia and LATAM, with India excluded as a destination market.
Glimepiride exporter and bulk supplier from India.
Procurement teams sourcing glimepiride are rarely buying one SKU. Formularies typically specify a strength ladder (1/2/3/4 mg, sometimes 6/8 mg) plus one or more metformin FDC ratios, and tender desks in the Gulf and Africa frequently split an award across single-agent and combination lines within the same lot. M Care sources glimepiride tablets and glimepiride-metformin FDCs from WHO-GMP certified Indian manufacturers against buyer-specified strength and pack requirements, with documentation (COA, stability data, regulatory dossiers where applicable) assembled per shipment. We do not hold standing MOQs, price lists, or lead times published on this page; those are confirmed per enquiry once destination, strength mix, and registration status are known.
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.
Sulfonylurea (second-generation), oral antidiabetic / insulin secretagogue, sourced and documented for export.
Glimepiride is an oral second-generation sulfonylurea for type 2 diabetes mellitus, distinguished within its class by a once-daily dosing schedule and a wide fixed-dose combination (FDC) footprint. It is marketed as single-agent tablets from 1 mg through 4 mg (with 6 mg and 8 mg available in some formularies), and as FDCs with metformin (multiple mg/mg ratios) and, in some markets, with pioglitazone. It is a CYP2C9 substrate, cleared through hepatic metabolism to an active hydroxy metabolite with renal and biliary excretion, which is why renal function and CYP2C9 genotype variability both matter clinically. It is not scheduled or controlled and carries no withdrawal history in our export markets; standard prescription-only, cold-chain-free logistics apply.
Active ingredient
Glimepiride. Sulfonylurea (second-generation), oral antidiabetic / insulin secretagogue.
Forms and strengths
1 mg; 2 mg; 3 mg; 4 mg.
Indications
Glimepiride is a second-generation sulfonylurea that lowers blood glucose in type 2 diabetes mellitus by stimulating insulin release from pancreatic beta cells, with an additional modest insulin-sensitising effect at peripheral tissue. Its defining clinical feature relative to older sulfonylureas is a once-daily dosing schedule, supported by a long duration of action and a metabolite (hydroxy-glimepiride) that retains some hypoglycaemic activity. It is used as monotherapy when metformin is contraindicated or not tolerated, and very commonly in combination with metformin, either as separate tablets or as a fixed-dose combination. It is metabolised in the liver primarily via CYP2C9 to its active metabolite, then further oxidised and excreted roughly 60 percent renally and 40 percent via bile/faeces, which is the basis for its renal and hepatic impairment cautions.
Administration
Oral. Tablet (immediate-release; also formulated as fixed-dose combination tablets with metformin, and in some markets with pioglitazone).
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.
We supply glimepiride tablets and glimepiride-metformin fixed-dose combinations to hospital procurement teams, licensed pharmaceutical importers, wholesalers and tender desks across the Gulf Cooperation Council states, Sub-Saharan and North African markets, the UK and EU, Southeast Asia, and Latin America. Enquiries typically come from buyers already running a sulfonylurea line in their formulary who need either a strength expansion (adding 3 mg or 4 mg to an existing 1-2 mg listing), a switch from an older sulfonylurea to glimepiride for its once-daily profile, or a metformin FDC to reduce pill burden in a diabetes programme with high polypharmacy. As with all our molecule listings, India is excluded as a served market; we source from India and export to the regions above only.
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 glimepiride.
Glimepiride's once-daily convenience is real but should not be read as a lower-vigilance drug. Dose it with the first main meal of the day; missed-meal hypoglycaemia after dosing is one of the more common preventable adverse events pharmacists see with this molecule, and it is worth flagging explicitly in patient counselling materials rather than assuming the once-daily schedule makes timing self-evident. Renal function should be checked before initiation and periodically thereafter, since both glimepiride and its active hydroxy metabolite depend on renal clearance and impairment extends drug exposure and hypoglycaemia duration, not just risk. Hepatic impairment carries a similar caution because hepatic metabolism via CYP2C9 is the first clearance step; avoid initiation in significant hepatic impairment and use the lowest effective dose where any hepatic function is compromised. Screen for G6PD deficiency where locally relevant before prescribing, as haemolytic anaemia is a recognised, rare but serious class reaction. CYP2C9 genetic polymorphism is worth knowing about even outside a pharmacogenomic-testing workflow: poor metabolisers can have meaningfully higher glimepiride exposure at standard doses, which partly explains why some patients on identical mg-for-mg doses show very different hypoglycaemia patterns. When dispensing a metformin fixed-dose combination, confirm the individual metformin dose against the patient's renal function separately from the glimepiride component, since FDC ratios do not always map cleanly onto what a prescriber would choose if titrating the two drugs independently. Alcohol should be flagged at counselling; while glimepiride's disulfiram-like reaction potential is lower than with chlorpropamide, flushing and hypoglycaemia potentiation with alcohol are both documented.
The documentation pack a regulator actually asks for.
M Care Exports is an Indian merchant-exporter holding ISO 9001:2015 certification for its trading and quality management operations. We do not manufacture glimepiride and do not hold WHO-GMP or WHO-PQ certification ourselves; those are manufacturing-site certifications. Every glimepiride line we quote is sourced from Indian manufacturing partners holding current WHO-GMP certification for their facilities, and, where a shipment requires it, from sites holding destination-specific registrations (for example a market-specific dossier or CoPP). Batch documentation, including certificates of analysis and, on request, stability and dossier support, is compiled per shipment against the buyer's destination-market requirements. India is not a market we serve; we export from India to the Gulf, Africa, UK/EU, Southeast Asia and LATAM only.
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.
Renal and hepatic impairment carry caution-to-contraindication labelling across markets due to hypoglycaemia risk from reduced clearance of glimepiride and its active metabolite; not a barrier to export but a prescribing-label matter the importer's regulatory team must carry through
G6PD deficiency haemolytic anaemia risk and rare hepatic/hematologic adverse reactions are known class and molecule-specific signals that belong in destination-market labelling and pharmacovigilance, not omitted from this page
No MOQ, price, lead time, client volume, or approval-date figures are stated on this page; all such figures are confirmed per enquiry and not published as general claims
Adjacent lines procurement desks order alongside glimepiride.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Gliclazide
Another diabetes & endocrine line ordered on the same formularies.
Insulin glargine
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 glimepiride.
- 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.
Glimepiride supply, the specific questions.
Why do buyers ask for glimepiride specifically instead of a generic sulfonylurea line item?
Formularies in several of our export markets specify glimepiride by molecule because its once-daily schedule is written into local prescribing guidance for patients on multi-drug regimens, where dosing frequency affects adherence. Tender desks in the Gulf and parts of Africa list glimepiride and gliclazide as distinct line items rather than interchangeable sulfonylureas, so a procurement officer asking for glimepiride by name is usually matching an existing formulary entry, not making a generic-class substitution.
What strengths and combination ratios does a typical glimepiride sourcing enquiry cover?
Single-agent tablets are commonly requested at 1 mg, 2 mg, 3 mg and 4 mg, with 6 mg and 8 mg present in some formularies for uptitrated patients. Glimepiride-metformin fixed-dose combinations come in several mg/mg ratios (glimepiride 1-2 mg paired with metformin 500-1000 mg being the most common range), and a smaller number of markets also carry a glimepiride-pioglitazone combination. Because the ratio and pack size vary by destination and by the buyer's own formulary, we confirm the exact SKU list per enquiry rather than publishing a fixed catalogue here.
How does renal impairment affect glimepiride sourcing or labelling requirements?
Glimepiride and its active metabolite are cleared substantially through the kidneys, so hypoglycaemia risk rises as renal function declines, and prescribing information across our export markets carries caution-to-contraindication language for moderate-to-severe renal impairment. This is a clinical prescribing matter for the importer's own regulatory and medical affairs teams, but it is also why buyers in markets with a high burden of diabetic nephropathy sometimes request gliclazide or a DPP-4 inhibitor alongside a glimepiride order rather than glimepiride alone, and we source to whichever mix the buyer specifies.
Is glimepiride associated with more or less hypoglycaemia than other sulfonylureas?
Head-to-head trial and pharmacovigilance data generally place glimepiride in a similar hypoglycaemia risk band to gliclazide and below glibenclamide, though it is not risk-free and severe hypoglycaemia has been reported, particularly in elderly patients, those with renal impairment, and those skipping meals after dosing. This is prescribing guidance for the buyer's clinical staff; we do not make comparative safety claims on stock we have not clinically evaluated, and defer to the product's approved labelling in each destination market.
Are there hematologic or hypersensitivity concerns pharmacists should flag on the label or in patient counselling?
Yes. Like other sulfonylureas, glimepiride carries a rare but recognised risk of haemolytic anaemia in patients with G6PD deficiency, and rare reports of leukopenia, thrombocytopenia, and hepatic reactions including cholestatic jaundice exist in post-marketing data. Cross-sensitivity with sulfonamide antibiotics is debated but noted cautiously in most labelling. These are prescribing and pharmacovigilance matters for the importing pharmacist, not claims M Care makes about the batches we source.
Does glimepiride interact with common co-administered drugs in a way that matters for combination-product sourcing?
Glimepiride is a CYP2C9 substrate, so strong CYP2C9 inhibitors (for example fluconazole) or inducers (for example rifampicin) can meaningfully shift its exposure and hypoglycaemia risk, and it interacts with warfarin. Beta-blockers can mask the adrenergic warning signs of hypoglycaemia. These interactions are why some buyers request combination products with metformin rather than co-packaging separate sulfonylurea and biguanide lines, simplifying the dispensing point even though the interaction profile itself is unchanged.
Is glimepiride subject to narcotic-style export controls or scheduling in any of M Care's markets?
No. Glimepiride is not a controlled or scheduled substance in the Gulf, African, UK/EU, Southeast Asian, or Latin American markets we export to, and it has no withdrawal history in these regions. Standard prescription-only medicine documentation, batch release testing, and destination-market registration requirements apply, the same as for other oral antidiabetics we supply.
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.