Dapagliflozin and metformin XR, Indian WHO-GMP supply of the SGLT2-biguanide combination for type 2 diabetes.
A fixed-dose oral combination, the generic equivalent of Xigduo XR (originator AstraZeneca): dapagliflozin drives insulin-independent urinary glucose excretion through SGLT2 blockade, while metformin cuts hepatic glucose output and improves insulin sensitivity. Together they lower HbA1c with low hypoglycaemia risk and modest weight loss. 5/500, 5/1000, 10/500 and 10/1000 mg extended-release tablets from Indian WHO-GMP-certified manufacturers, in wholesale and tender volumes. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 5/500, 5/1000, 10/500, 10/1000 mg XR · generic equivalent of Xigduo XR · CTD dossier on file · exporter, not manufacturer.
Active ingredients
Dapagliflozin, a selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, plus metformin hydrochloride, the first-line biguanide. The pairing is complementary: dapagliflozin removes glucose through the kidney independent of insulin, metformin suppresses hepatic gluconeogenesis. Supplied from Indian WHO-GMP-certified manufacturers; M Care does not manufacture.
Strengths stocked
Extended-release tablets in dapagliflozin 5 mg / metformin 500 mg, 5 / 1000, 10 / 500 and 10 / 1000 mg, once daily with the evening meal, total daily dapagliflozin 10 mg. Single agents (dapagliflozin 5 and 10 mg; metformin 500/850/1000 mg) and immediate-release combinations supplied where a market prefers them.
Indication
Type 2 diabetes mellitus, as an adjunct to diet and exercise, where treatment with both dapagliflozin and metformin is appropriate, either as initial combination or to replace separate tablets. The SGLT2 component additionally carries recognised cardiovascular and renal benefit, which is why this class has moved up the diabetes treatment algorithm.
Mechanism and benefit
SGLT2 blockade lowers the renal glucose threshold, excreting ~70 g glucose daily, while metformin improves insulin sensitivity. Net effect: meaningful HbA1c reduction, low intrinsic hypoglycaemia risk (neither agent drives insulin secretion), modest weight loss and a small blood-pressure reduction. A rational fixed-dose pairing for tender formularies.
Storage and pack
Store below 30°C, protect from moisture, in the original blister or HDPE bottle. Alu-Alu or Alu-PVDC blister to destination standard, hospital and retail pack sizes (28, 30, 56, 98). Shelf life typically 24 months, minimum 18 months at dispatch. Standard ambient dispatch lane.
Safety headlines
Metformin: lactic acidosis risk, contraindicated below eGFR 30, hold around contrast imaging. Dapagliflozin: euglycaemic ketoacidosis, genital mycotic and urinary infection, volume depletion, and the rare Fournier's gangrene warning. Full grading on the SmPC.
Diabetes and chronic-disease formularies, hospital tenders and chain pharmacies.
India is our origin. We do not sell into the Indian market. This combination is exported only.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Type 2 diabetes prevalence in the GCC is among the highest in the world, so SGLT2-based combinations are a fast-growing chronic-disease formulary line. Supplied through licensed importers against MoH and insurer formulary tenders (NUPCO and SFDA; MoHAP, DHA and DoH; Kuwait, Oman, Qatar and Bahrain MoH). Full CTD for MoH registration and GCC central registration.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania
Rising non-communicable-disease burden is pushing modern oral antidiabetics into African public-sector and private-channel formularies (NAFDAC, KEMSA, FDA Ghana, SAHPRA, EFDA, TMDA). Indian generic SGLT2 combinations bring the cost down to where a public programme can afford them, a real access lever. Donor and NGO procurement supported.
United Kingdom and Europe
Supplied through licensed importers and wholesalers, subject to the originator patent and SPC position in each market, which we confirm per country before quoting. Ph.Eur.-grade product with QP certification on EU arrival, CTD and CoPP prepared for BfArM, ANSM and comparable bodies. UK supply via licensed wholesaler or the Specials route where applicable.
Latin America and ASEAN
Brazil (ANVISA), Mexico (COFEPRIS) and ASEAN (Philippines FDA, Vietnam DAV, Malaysia NPRA) through licensed importers against chronic-disease tenders. Bioequivalence data and CTD prepared for destination recognition. M Care does not hold US FDA or TGA registration for this molecule, and patent position is confirmed per market before any offer.
Renal thresholds, euglycaemic ketoacidosis, sick-day rules and the contrast-imaging hold.
The combination is taken once daily with the evening meal as an extended-release tablet, with the dose built to a total daily dapagliflozin of 10 mg and metformin titrated to tolerance and renal function. Renal function governs the metformin component: the fixed-dose combination is contraindicated below an eGFR of 30 ml/min/1.73m², used with caution and dose review from 30-45, and metformin should be temporarily held around iodinated-contrast imaging and during any acute illness with dehydration or hypoxia because of the lactic-acidosis risk. The dapagliflozin component can cause euglycaemic diabetic ketoacidosis, ketoacidosis with only modestly raised or near-normal glucose, so counsel patients on ketone awareness and apply sick-day rules, pausing the SGLT2 inhibitor during acute illness, prolonged fasting, surgery or very low carbohydrate intake. Genital mycotic infections and urinary tract infections are more frequent on SGLT2 inhibitors, perineal hygiene counselling reduces them, and the rare but serious Fournier's gangrene (necrotising fasciitis of the perineum) is a labelled warning requiring urgent surgical referral for any perineal pain, swelling or erythema with fever. Volume depletion and symptomatic hypotension can occur, particularly in the elderly, on loop diuretics, or with low baseline blood pressure, so review concomitant antihypertensives. Long-term metformin can cause vitamin B12 deficiency, worth periodic checking. There is a low intrinsic hypoglycaemia risk from the combination itself, but the risk rises when it is added to a sulfonylurea or insulin, where a dose reduction of those agents is usually needed. The SmPC carries the full interaction and monitoring detail for the receiving formulary.
The documentation pack a regulator actually asks for.
Metformin is a WHO Essential Medicines List item and dapagliflozin was added to the list in 2023. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls for the fixed-dose combination, in eCTD-ready format where accepted, Module 2 quality overall summary included. Extended-release dissolution method and the two-active uniformity controls documented.
Bioequivalence
Comparative bioequivalence data against the reference listed product available where the registration requires it, covering both actives and the extended-release dissolution profile.
CoA and MoA, per batch
Assay of both actives, dissolution including the XR profile, related substances per ICH, content uniformity, water content, signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (India), apostilled where required, notarised copies in the shipping pack. M Care does not hold US FDA or TGA registration for this molecule, confirm the regulatory route on enquiry.
Pack insert, labels, artwork
Destination-language leaflet and labelling carrying the renal-threshold, lactic-acidosis, euglycaemic-ketoacidosis, genital-infection and Fournier's-gangrene warnings. Artwork QC before print.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C. Diabetic ketoacidosis, genital and urinary infection, volume depletion and lactic acidosis are the priority signals.
The diabetes formulary, oral and injectable.
A diabetes tender is rarely a single molecule. Buyers pair modern oral combinations with insulins and the rest of the endocrine shelf.
Insulin glargine
Long-acting basal insulin biosimilar. Vial and pre-filled pen. Cold-chain validated supply for diabetes programmes.
Levothyroxine
Thyroid hormone replacement. 25-200 mcg tablets, the high-volume endocrine maintenance line.
Diabetes & endocrine range →
Oral antidiabetics, SGLT2 and DPP-4 combinations, insulins, thyroid and bone-metabolism therapy across the endocrine shelf.
Full portfolio →
Eighteen therapeutic categories across orals, injectables, biologicals and surgical consumables, exported to forty-nine markets.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (5/500, 5/1000, 10/500, 10/1000), pack format, quantity, destination, and channel: MoH or insurer formulary tender, hospital, chain pharmacy, or importer stock. Flag if single agents or an immediate-release combination are needed.
- We confirm patent position and route. We check the originator patent and SPC position in the destination market and route to the right WHO-GMP line; we will not quote into a market where supply is not clear.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status per destination, and the documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch, in-transit logging and on-arrival inspection.
- After delivery. Batch records, CoA and stability data archived for the full shelf life, PV contact opened on registration.
Dapagliflozin-metformin supply, the specific questions.
Is this the generic equivalent of Xigduo XR?
Yes. We supply the generic dapagliflozin plus metformin hydrochloride fixed-dose combination, which is the generic equivalent of the originator brand Xigduo XR (originator AstraZeneca). We supply the generic molecule, not the branded product, and we are clear about that distinction. Indian WHO-GMP generic versions are registered and tendered across many markets where the originator patent position allows, at a materially lower cost than the brand.
What strengths of dapagliflozin and metformin do you supply?
The four standard extended-release strengths: dapagliflozin 5 mg / metformin 500 mg, 5 mg / 1000 mg, 10 mg / 500 mg, and 10 mg / 1000 mg, taken once daily with the evening meal. The total daily dapagliflozin dose is 10 mg and metformin is titrated to tolerance and renal function. Immediate-release dapagliflozin-metformin combinations and the single agents (dapagliflozin 5 mg and 10 mg tablets, metformin 500/850/1000 mg) are available where a market prefers them. All from WHO-GMP-certified Indian manufacturers.
Is M Care a manufacturer of dapagliflozin-metformin?
No. M Care is a merchant exporter. We supply the dapagliflozin plus metformin combination from Indian WHO-GMP-certified manufacturers and handle export, documentation, registration support and freight. We do not run a manufacturing plant ourselves. For a buyer, that means we route each order to the right WHO-GMP line for the destination and carry the regulatory and logistics paperwork.
What are the key safety points for the combination?
From the metformin component: lactic acidosis is the rare but serious risk, the combination is contraindicated below an eGFR of 30 ml/min/1.73m², used with caution from 30-45, and should be held around iodinated-contrast imaging and acute illness; long-term use can lower vitamin B12. From the dapagliflozin component: euglycaemic diabetic ketoacidosis can occur with near-normal glucose, genital mycotic infections and urinary infections are more frequent, volume depletion and hypotension can occur, and rare necrotising fasciitis of the perineum (Fournier's gangrene) is a labelled warning. The destination-language SmPC carries the full table.
Which markets can you ship dapagliflozin-metformin into?
GCC chronic-disease and diabetes formulary tenders through licensed importers (NUPCO and SFDA, MoHAP/DHA/DoH, and the Kuwait, Oman, Qatar and Bahrain MoH); African public-sector and chain-pharmacy supply (NAFDAC, KEMSA, FDA Ghana, SAHPRA, EFDA, TMDA, NDA); the UK and EU through licensed importers; and Latin America (ANVISA, COFEPRIS) and ASEAN (Philippines FDA, Vietnam DAV, Malaysia NPRA). Registration and patent position vary by country and we confirm both per market. M Care does not hold US FDA or TGA registration for this molecule. We do not supply into India. Full coverage at markets.
What documentation ships with a dapagliflozin-metformin consignment?
A batch-specific Certificate of Analysis (assay of both actives, dissolution including the extended-release profile, related substances per ICH, uniformity, water content), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, Certificate of Origin, destination-language pack insert with the lactic-acidosis, ketoacidosis, renal-function and genital-infection warnings, and stability/temperature documentation. Full CTD Module 3 dossiers are available against an NDA, with bioequivalence data for the combination where the registration requires it, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength (5/500, 5/1000, 10/500, 10/1000), pack format, volume, destination, and channel: MoH or insurer formulary tender, hospital, chain pharmacy, or importer stock. That's the enquiry. Everything else is on us.