Jardiance (empagliflozin) now carries FDA and EMA label extensions into heart failure and chronic kidney disease, not just type 2 diabetes, which is why tender desks are re-scoping it as a cardio-renal drug, not a diabetes drug alone.
Jardiance (empagliflozin) is Boehringer Ingelheim's SGLT2 inhibitor, now labelled across type 2 diabetes, heart failure and chronic kidney disease. M Care sources it through licensed Indian distribution channels and dispatches to hospital pharmacies, MoH tender desks and licensed wholesalers across our 49 export markets. We are a merchant exporter, not a manufacturer.
Empagliflozin exporter and bulk supplier from India.
Empagliflozin's label expansion into heart failure and CKD has pushed it onto cardiology and nephrology formularies, not just diabetes protocols, so tender volumes have widened accordingly. The Mumbai desk quotes Jardiance for MoH tenders, NGO procurement rounds and private hospital group contracts against firm order quantities, with CTD/eCTD documentation and cold-chain-free logistics since this is an oral solid. We work from licensed Indian channels tied to the originator; there is no generic empagliflozin to source in most of our regulated destination markets while patent protection holds.
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.
Sodium-glucose co-transporter-2 (SGLT2) inhibitor, sourced and documented for export.
Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It lowers blood glucose by blocking renal glucose reabsorption, increasing urinary glucose excretion, independent of insulin.
FDA-licensed indications: adjunct to diet and exercise for glycaemic control in adults and paediatric patients 10 years and older with type 2 diabetes; to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease; to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure (across the ejection fraction spectrum); and to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease at risk of progression. Destination-market labelling may vary; refer to other licensed indications per local labelling.
Jardiance is supplied as a film-coated tablet in 10 mg and 25 mg strengths. It is a room-temperature product: store at 20-25°C, with excursions permitted to 15-30°C. No cold chain is required, which simplifies logistics into hot-climate GCC and African destinations relative to injectable diabetes products.
Active ingredient
empagliflozin. Sodium-glucose co-transporter-2 (SGLT2) inhibitor.
Forms and strengths
10 mg; 25 mg.
Indications
Licensed for glycaemic control in type 2 diabetes, and to reduce cardiovascular death and heart failure hospitalisation in adults with heart failure and to slow progression in chronic kidney disease at risk of progression, per FDA labelling.
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 we serve for empagliflozin include hospital pharmacy procurement teams building cardiology and endocrinology formularies, MoH tender desks in the GCC and African ministries of health widening diabetes protocols to cover heart failure and CKD indications, licensed wholesalers and importers restocking retail-facing pharmacy chains, and NGO procurement units supporting non-communicable disease programmes where SGLT2 inhibitors are being added to essential-medicine lists at country level.
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 empagliflozin.
Dosing starts at 10 mg once daily in the morning, with or without food, and may be titrated to 25 mg once daily in patients tolerating the lower dose who need additional glycaemic control. For heart failure and CKD indications, 10 mg once daily is the labelled dose; there is no titration step for those indications specifically, so confirm which indication is driving the prescription before assuming an up-titration is due.
Renal function needs checking before initiation and periodically thereafter. For the glycaemic-control indication specifically, empagliflozin is not recommended once eGFR falls below 30 mL/min/1.73m2, per the current US label. The heart failure and CKD indications have been studied in patients down to an eGFR of 20 mL/min/1.73m2, and patients already established on empagliflozin are not required to discontinue solely because eGFR falls below that level during treatment. eGFR considerations therefore differ by indication, so confirm which indication is driving the prescription rather than applying one cutoff across all three.
Volume depletion is the most common practical issue on the ward: assess volume status before starting in patients with hypotension risk, renal impairment, or those on diuretics or antihypertensives, and monitor for signs of volume depletion after initiation. Genital mycotic infections and, rarely, necrotising fasciitis of the perineum (Fournier's gangrene) are label warnings; counsel patients on genital hygiene and instruct them to seek urgent review for perineal pain, tenderness, erythema or fever.
No cold chain is required. It is a standard room-temperature tablet, stored at 20-25°C with 15-30°C excursions permitted, and dispensed in its original container with desiccant to protect against humidity. There is no FDA- or EMA-licensed generic or biosimilar empagliflozin available while Jardiance remains under patent protection in most regulated markets; substitution is not currently an option for buyers in those jurisdictions.
The documentation pack a regulator actually asks for.
As an oral solid, empagliflozin travels through standard ambient-temperature logistics rather than a validated cold chain, which keeps documentation focused on batch release, CoA, and import licensing rather than temperature-excursion records. M Care's Mumbai desk prepares the CTD/eCTD-format dossier support that destination-market importers and MoH tender desks require, and works within CDSCO export licensure for outbound shipment from India.
Jardiance is a patented originator brand from Boehringer Ingelheim. M Care sources it through licensed Indian distribution channels tied to the originator, not from generic manufacturers, because no FDA- or EMA-approved generic empagliflozin currently exists. We state this plainly to buyers rather than implying a generic option that does not exist: importers should plan tender specifications around brand-name Jardiance supply for now.
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 empagliflozin.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Gliclazide
Another diabetes & endocrine line ordered on the same formularies.
Glimepiride
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 empagliflozin.
- 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.
Empagliflozin supply, the specific questions.
Is there a generic or biosimilar version of empagliflozin?
No. Jardiance remains under patent protection in most regulated markets and there is no FDA- or EMA-approved generic or biosimilar empagliflozin at present. M Care sources Jardiance through licensed Indian distribution channels tied to the originator, Boehringer Ingelheim.
Does Jardiance need cold-chain shipping?
No. Jardiance is a film-coated tablet stored at 20-25°C, with excursions permitted to 15-30°C. It ships under standard ambient-temperature logistics, not validated cold chain, which is simpler than our injectable diabetes lines into hot-climate destinations.
Can M Care supply Jardiance to our market?
Yes, through licensed Indian channels on an import basis appropriate to your destination country's regulatory framework. Contact the Mumbai desk with your quantity and country requirement and we will confirm the licensing route and documentation needed for your import.
What strengths of Jardiance are available?
Jardiance is supplied as 10 mg and 25 mg film-coated tablets. Dosing starts at 10 mg once daily and may be titrated to 25 mg for additional glycaemic control in the type 2 diabetes indication; the heart failure and CKD indications are labelled at 10 mg once daily.
What indications is Jardiance licensed for, beyond type 2 diabetes?
The FDA label now covers reduction of cardiovascular death and heart failure hospitalisation in adults with heart failure, and reduction of eGFR decline, end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease at risk of progression, in addition to glycaemic control in type 2 diabetes. Destination-market labelling should be checked for locally licensed indications.
What documentation does M Care provide for a Jardiance tender?
We prepare CTD/eCTD-format dossier support and work within CDSCO export licensure for outbound shipment from India, alongside batch CoA and import documentation aligned to your destination market's tender requirements.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-26.
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.