Janumet (sitagliptin/metformin) is a fixed-dose type 2 diabetes tablet in two forms, a twice-daily immediate-release tablet and the once-daily Janumet XR, and importers must specify the form, strength and market label before any quote is useful.
M Care Exports supplies Janumet (sitagliptin/metformin), the Merck Sharp & Dohme combination of a DPP-4 inhibitor and metformin for adults with type 2 diabetes, in brand or generic form. I'm looking for Janumet is the usual opening line from a UAE or Nigerian importer, and the first question back is which Janumet: the US twice-daily tablet, the once-daily Janumet XR, or the EU labelling sold as Janumet, Velmetia or Efficib. M Care is a merchant exporter: we source against your specification and dispatch on quote, not from our own manufacturing.
Sitagliptin/metformin exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes sitagliptin/metformin against a written specification: originator Janumet or Janumet XR, or a generic equivalent; the strength (50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 mg or, for XR, 100 mg/1,000 mg); the pack count; and the labelling the destination regulator has registered. We need a partner for this product is common wording from distributors who have a registration in hand and need a dependable, documented source. Send the registered strength and pack, and we confirm what can be supplied against it before anything is priced.
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.
DPP-4 inhibitor and biguanide fixed-dose combination, sourced and documented for export.
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride is a biguanide. Janumet combines them in one oral tablet as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes; it is not for type 1 diabetes, and the US label notes it has not been studied in patients with a history of pancreatitis. The US immediate-release Janumet is available as sitagliptin 50 mg with metformin 500 mg or 1,000 mg, taken twice daily with meals, to a maximum of 100 mg sitagliptin and 2,000 mg metformin a day. Janumet XR is a film-coated extended-release tablet in 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg, taken once daily with a meal and swallowed whole, never split, crushed or chewed. In the EU the same combination is authorised to Merck Sharp & Dohme B.V. under three names, Janumet, Velmetia and Efficib, each as 50 mg/850 mg and 50 mg/1,000 mg tablets. The 50 mg/850 mg strength is therefore an EU presentation and does not appear on the US Janumet label.
Active ingredient
Sitagliptin (as phosphate monohydrate) and metformin hydrochloride. DPP-4 inhibitor and biguanide fixed-dose combination.
Forms and strengths
50/500 mg film-coated tablet (sitagliptin/metformin HCl); 50/850 mg film-coated tablet (sitagliptin/metformin HCl, EU); 50/1000 mg film-coated tablet (sitagliptin/metformin HCl); 100/1000 mg extended-release tablet (Janumet XR).
Indications
Fixed-dose oral combination of sitagliptin and metformin hydrochloride, an adjunct to diet and exercise for glycaemic control in adults with type 2 diabetes.
Administration
Oral. Film-coated tablet (immediate-release) and film-coated extended-release 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 are hospital and outpatient pharmacies running diabetes clinics, ministry of health and hospital tender desks that list DPP-4 combinations beside metformin and sulfonylureas, licensed importers and distributors in the GCC, Africa and the UK, and private-sector wholesalers with an existing registration for the brand or a generic. Because Janumet is a chronic-use oral tablet with no cold chain and no specialist administration, it moves through retail and hospital channels alike, so the buying decision is mostly about registration status, labelling and strength, not handling.
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 sitagliptin/metformin.
Specify the form first. Janumet is a twice-daily tablet taken with meals, while Janumet XR is once daily with a meal and must be swallowed whole; swapping one for the other on a dispensing list changes the regimen, not just the strength. Both US labels carry a boxed warning for metformin-associated lactic acidosis, and list eGFR below 30 mL/min/1.73 m2 and metabolic acidosis, including diabetic ketoacidosis, as contraindications. Both US labels also report acute pancreatitis and say to stop the drug if it is suspected. Renal function should be assessed before and during treatment, and the Janumet XR label addresses pausing around iodinated contrast in higher-risk patients. Storage on both US labels is 20-25 C, with excursions permitted to 15-30 C, and Janumet XR is to be kept in a dry place with the cap tightly closed. No reconstitution is needed.
The documentation pack a regulator actually asks for.
Sitagliptin/metformin is an oral solid dosage form and travels on ambient lanes, so there is no cold-chain requirement. What import-side regulators ask for is batch-level certificates of analysis, export documentation and, where the destination requires it, CTD or country-specific dossier support. On the generic question, Par Health announced on 24 July 2026 the US launch of what it describes as the first and currently the only FDA-approved generic of Janumet XR. In the EU, the EMA lists Janumet, Velmetia and Efficib as authorised to Merck Sharp & Dohme B.V., and we have not confirmed EU generics by name. We have not verified the Indian generic position from a primary source and do not state it. Originator and generic supply are both quoted, against the registration the buyer holds.
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 sitagliptin/metformin.
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 sitagliptin/metformin.
- 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.
Sitagliptin/metformin supply, the specific questions.
What is the price of Janumet XR 50/1000, and what decides the landed price for an importer?
M Care Exports does not publish a price for Janumet or Janumet XR, because the landed cost depends on facts that differ per order. These are originator or generic, the exact strength and pack count, the quantity, the destination's registration route, the labelling the regulator has approved, and the Incoterms. Janumet XR is a once-daily extended-release tablet and is quoted separately from the twice-daily Janumet. Send your registered strength, pack and destination and the Mumbai desk quotes per destination.
I'm looking for Janumet 50/1000 in the UAE. Can M Care Exports supply it?
Yes, M Care Exports can quote Janumet 50 mg/1,000 mg, or a generic sitagliptin/metformin equivalent, to UAE importers and distributors. The 50 mg/1,000 mg strength exists on both the US and EU labels. Before we quote we need to know whether your Emirates Drug Establishment (EDE) registration is for the brand or a generic, and which pack it covers. We do not assume a registration status; the importer confirms it, and we align documents to it.
Is there a Janumet 50/850, and is it the same as Velmetia or Efficib?
Yes. The 50 mg/850 mg strength is an EU presentation. Per the European Medicines Agency, Merck Sharp & Dohme B.V. holds authorisations for Janumet, Velmetia and Efficib, each covering sitagliptin 50 mg with metformin 850 mg or 1,000 mg tablets. The US Janumet label lists 50 mg/500 mg and 50 mg/1,000 mg instead. If your register names 50/850, tell us the brand name on it, because the three EU names are separate authorisations and the carton must match.
What is Janumet 50/500 used for?
Janumet 50 mg/500 mg is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes, per the US label. It is not for type 1 diabetes. It pairs sitagliptin, a DPP-4 inhibitor, with metformin, and is taken twice daily with meals, up to 100 mg sitagliptin and 2,000 mg metformin a day. The lower metformin strength lets prescribers titrate to tolerance. Prescribing decisions rest with the treating clinician and the destination-country label.
What is the difference between Janumet and Janumet XR, and which pack sizes exist?
Janumet is a twice-daily immediate-release tablet taken with meals. Janumet XR is a once-daily extended-release tablet taken with a meal and swallowed whole, available as 50/500, 50/1,000 and 100/1,000 mg. The 100 mg/1,000 mg strength exists only as XR. The US Janumet label lists bottles of 60 and 180 plus bulk bottles of 1,000; Janumet XR is listed in 60 and 180 for the 50 mg strengths and 30 and 90 for 100/1,000. EU pack sizes differ, so we quote the pack your register names.
Is there a generic of Janumet, and how do the US, EU and India differ?
In the US, Par Health announced on 24 July 2026 the launch of what it calls the first and currently the only FDA-approved generic of Janumet XR. In the EU, the EMA lists the originator names Janumet, Velmetia and Efficib under Merck Sharp & Dohme B.V.; we have not confirmed an EU generic. We have not verified the Indian position from a primary source, so we do not state it. M Care Exports quotes the originator or a generic, according to what your tender or registration permits.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
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.