Farxiga (dapagliflozin) now has FDA-approved generic tablets alongside the AstraZeneca original, so buyers can choose between brand and generic supply depending on the market.
Farxiga (dapagliflozin), AstraZeneca's SGLT2 inhibitor, is licensed for type 2 diabetes, heart failure and chronic kidney disease. The US patent position opened to generic competition in 2026, and the EU already carries an EMA-authorised generic. M Care is a merchant exporter: we route both brand-channel and generic dapagliflozin tablets to importers and tenders through licensed Indian distribution and manufacturing partners, we do not manufacture either ourselves.
Dapagliflozin exporter and bulk supplier from India.
For MoH tenders and hospital-formulary listings, dapagliflozin now splits into two sourcing lanes: originator Farxiga/Forxiga through licensed brand-distribution channels, and generic dapagliflozin tablets through WHO-GMP partner manufacturing sites once local patent status and marketing authorisation permit sale in that market. Where a generic is registered, its approved indications can be narrower than the originator's, so M Care's Mumbai desk tracks which lane and which indications apply market by market and builds the CTD dossier and export documentation to match, so a tender response names the correct product, licensing basis and indication scope rather than assuming brand-only, generic-only or full interchangeability.
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.
SGLT2 (sodium-glucose cotransporter-2) inhibitor, sourced and documented for export.
Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor. It blocks glucose reabsorption in the renal proximal tubule, lowering blood glucose and increasing urinary glucose excretion, with additional haemodynamic and renal effects that extend its use beyond glycaemic control.
FDA-licensed indications for Farxiga cover three separate populations: adults with type 2 diabetes mellitus as an adjunct to diet and exercise, and to reduce the risk of hospitalisation for heart failure in those with established cardiovascular disease or multiple cardiovascular risk factors; adults with heart failure, to reduce cardiovascular death, heart-failure hospitalisation and urgent heart-failure visits; and adults with chronic kidney disease at risk of progression, to reduce sustained eGFR decline, end-stage kidney disease, cardiovascular death and heart-failure hospitalisation. EMA licensing for Forxiga aligns closely: type 2 diabetes, chronic heart failure, and chronic kidney disease, each per the EU SmPC. Buyers should confirm the exact wording licensed in their own destination-country labelling.
Dapagliflozin is supplied as a film-coated oral tablet, 5 mg and 10 mg strengths. It is an oral solid dose form: no cold chain is required, and it ships and stores under standard ambient warehousing rather than the 2-8°C chain needed for the injectable diabetes and obesity biologics in this category.
Active ingredient
dapagliflozin. SGLT2 (sodium-glucose cotransporter-2) inhibitor.
Forms and strengths
5 mg; 10 mg.
Indications
Licensed for type 2 diabetes mellitus, heart failure (to reduce cardiovascular death and heart-failure hospitalisation), and chronic kidney disease at risk of progression, per FDA label and EMA SmPC.
Administration
oral. Film-coated 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 dapagliflozin span hospital pharmacy formularies stocking it for heart-failure and CKD indications alongside diabetes clinics, MoH tender desks in GCC and African markets adding SGLT2 inhibitors to essential-medicine and NCD procurement lists, licensed wholesalers and importers building out a cardiometabolic portfolio, and NGO or donor-funded procurement programmes sourcing affordable oral glucose-lowering therapy for non-communicable disease control.
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 dapagliflozin.
Dosing differs by indication, and getting this into a formulary note matters for tender specification. For type 2 diabetes, the FDA label starts patients at 5 mg once daily, with an option to increase to 10 mg once daily if additional glycaemic control is needed and tolerated. For heart failure and for chronic kidney disease, the label specifies 10 mg once daily as the treatment dose with no titration step, so a pharmacy stocking dapagliflozin for cardio-renal indications should expect single-strength, steady-state ordering rather than a titration pack.
As an SGLT2 inhibitor, dapagliflozin carries label warnings a receiving pharmacist should flag on intake: ketoacidosis (including euglycaemic presentations, sometimes without marked hyperglycaemia) and volume depletion or hypotension. It is not indicated for type 1 diabetes, where SGLT2 inhibitors as a class carry a materially increased ketoacidosis risk. Renal function should be assessed before initiation and monitored per the label, since efficacy on glycaemic endpoints is reduced at lower eGFR even though the heart-failure and CKD indications extend use into more advanced renal impairment.
There is no premedication or infusion-reaction protocol to build into standing orders here, unlike the injectable agents in this category: dapagliflozin is a once-daily oral tablet with no administration device, no reconstitution step and no cold-chain handling from receipt through dispensing.
On substitution: FDA-approved generic dapagliflozin tablets are now on the US market alongside Farxiga, but the current US generic labelling is narrower than the brand, covering type 2 diabetes (including the heart-failure-hospitalisation-risk-reduction indication tied to type 2 diabetes with cardiovascular disease or risk factors) and not yet the standalone heart-failure or chronic kidney disease indications carried by branded Farxiga. In the EU, the authorised generic Dapagliflozin Viatris carries the same type 2 diabetes, heart failure and chronic kidney disease indications as Forxiga. Procurement teams building a formulary line should specify explicitly whether the brand or a licensed generic is wanted, confirm which indications that specific product's approved labelling covers in the destination country, and not assume brand and generic are interchangeable across all indications.
The documentation pack a regulator actually asks for.
Every dapagliflozin shipment M Care handles, brand or generic, moves with a CTD-format dossier built around the manufacturing site's WHO-GMP status and the destination market's own registration requirements. As an oral solid with no cold-chain dependency, the documentation chain centres on batch release testing, stability data supporting the labelled shelf life, and the CDSCO export licence covering dispatch from India, rather than on the temperature-logging paperwork a biologic shipment needs.
On the brand-versus-generic question: Farxiga/Forxiga is AstraZeneca's originator product, and M Care sources it through licensed Indian distribution channels rather than manufacturing it. Generic dapagliflozin now has FDA approval in the US and EMA authorisation in the EU market, so for markets where a licensed generic is registered, M Care can also source it through WHO-GMP partner manufacturing sites. Approved indications can differ between the originator and a given generic (the current US generic's labelling, for example, does not yet carry the standalone heart-failure and chronic kidney disease indications held by branded Farxiga), so we confirm the specific product's registered indications before a tender response is built. We state plainly which lane any given shipment falls under; we never represent a generic as the branded product or vice versa.
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 dapagliflozin.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Dulaglutide
Another diabetes & endocrine line ordered on the same formularies.
Empagliflozin
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 dapagliflozin.
- 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.
Dapagliflozin supply, the specific questions.
Is there a generic version of Farxiga?
Yes, in some markets. The US FDA approved the first generic dapagliflozin tablets in April 2026, though the initial US generic labelling covers type 2 diabetes (including the heart-failure-hospitalisation-risk-reduction indication tied to type 2 diabetes) and not yet the standalone heart-failure or chronic kidney disease indications carried by branded Farxiga. The EU has a full-indication EMA-authorised generic, Dapagliflozin Viatris, covering type 2 diabetes, heart failure and chronic kidney disease. Availability, indication scope and patent-clearance status all vary by country, so we confirm current local status before quoting a generic line.
Can M Care supply Farxiga itself, not just a generic?
Yes. As a merchant exporter we source Farxiga/Forxiga through licensed Indian distribution channels of the originator. We do not manufacture it; we manage the export documentation and licensed sourcing chain.
Does dapagliflozin need cold-chain shipping?
No. It is an oral film-coated tablet stored and transported at standard ambient warehouse conditions, unlike the injectable SGLT2-adjacent or GLP-1 biologics also used in diabetes care.
What indications is dapagliflozin licensed for?
Per the FDA label for branded Farxiga: type 2 diabetes mellitus, heart failure (to reduce cardiovascular death and heart-failure hospitalisation), and chronic kidney disease at risk of progression. EMA licensing for Forxiga covers the same three areas under the EU SmPC. A given generic product's approved indications can be narrower than the brand's, so always check the specific wording on your destination-country labelling and the labelling of the exact product being supplied.
Can you supply Farxiga into my market even though M Care doesn't hold a local marketing authorisation?
We supply on an import basis: your importer of record or MoH tender process handles local registration and marketing authorisation, and M Care provides the CTD dossier, WHO-GMP sourcing evidence and export documentation needed to support that registration and the shipment itself.
What strengths are available?
5 mg and 10 mg film-coated tablets, matching the FDA and EMA licensed strengths. Type 2 diabetes dosing typically starts at 5 mg with an option to step up to 10 mg; the heart-failure and CKD indications use 10 mg once daily with no titration.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.