Tradjenta (linagliptin) needs no dose adjustment across any stage of renal impairment, the single label feature that separates it from every other DPP-4 inhibitor.
Tradjenta (linagliptin), from Boehringer Ingelheim, and its FDA-approved generic linagliptin are both sourceable through M Care's licensed Indian channels. We are a merchant exporter, not a manufacturer: we route each order through the dossier and quality chain that fits the buyer's regulatory market. Request a quote and tell us whether your tender specifies brand or generic.
Linagliptin exporter and bulk supplier from India.
For MoH tenders and hospital formularies specifying linagliptin, M Care sources both Tradjenta and generic linagliptin film-coated tablets against confirmed purchase orders. Volumes route through licensed Indian channels for the brand, and through WHO-GMP manufacturing partners for the generic. CTD/eCTD dossier support is available for markets that require it, and cold-chain is not a factor for this oral solid, which simplifies freight and warehousing planning for large-lot tender fulfilment.
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.
Dipeptidyl peptidase-4 (DPP-4) inhibitor, sourced and documented for export.
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It slows the breakdown of incretin hormones GLP-1 and GIP, which increases insulin release and lowers glucagon secretion in a glucose-dependent manner.
Tradjenta is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, per the FDA label. The EMA-authorised Trajenta carries the same core indication, as monotherapy when metformin is inappropriate due to intolerance or contraindicated due to renal impairment, and in combination with other diabetes medicines, including metformin, a sulphonylurea, or insulin, when these alone do not give adequate control. It is not indicated for type 1 diabetes or the treatment of diabetic ketoacidosis, per the EU label.
Supplied as a 5 mg film-coated tablet, the only marketed strength. Store at 20C to 25C (68F to 77F), with excursions permitted to 15C to 30C (59F to 86F). No cold chain is required; this is a standard oral solid dosage form.
Active ingredient
linagliptin. Dipeptidyl peptidase-4 (DPP-4) inhibitor.
Forms and strengths
5 mg.
Indications
Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, per FDA label; EMA-authorised Trajenta adds monotherapy use when metformin is inappropriate due to intolerance or contraindicated due to renal impairment, and combination use with other diabetes medicines including metformin, a sulphonylurea, or insulin.
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 linagliptin through M Care typically include NHS trust pharmacy buyers and licensed UK wholesalers sourcing Tradjenta on brand-name tenders, GCC MoH tender desks (Saudi Arabia, UAE, Kuwait) specifying either brand or WHO-GMP generic linagliptin for national diabetes formularies, African MoH procurement units and licensed importers in Nigeria, Kenya and Ghana building out type 2 diabetes treatment lines, and regional wholesalers looking to add a renal-impairment-safe DPP-4 option alongside metformin and sulphonylurea stock.
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 linagliptin.
Dosing is flat and simple: 5 mg once daily, orally, with or without food, and there is no titration schedule to manage. The distinguishing point for procurement and clinical teams is renal dosing: both the FDA and EU labels state no dose adjustment is required for patients with renal impairment, without a stage-based cut-off, because linagliptin is cleared predominantly through the enterohepatic route rather than the kidney. That is unusual among DPP-4 inhibitors; sitagliptin and saxagliptin both carry renal-based dose reductions on their labels, so linagliptin is often the formulary default for CKD or elderly diabetic populations where renal function is unpredictable.
There is no hepatic dose adjustment either, per the FDA label, which further simplifies use in mixed-morbidity populations common to tender-supplied hospital settings.
Storage is standard room temperature, 20C to 25C with 15C to 30C excursions permitted, so this product needs no cold chain and no special handling once it clears customs. That materially simplifies freight, bonded warehousing, and last-mile distribution for tender lots compared with insulin or GLP-1 injectables in the same diabetes category.
A generic linagliptin tablet (labeller: Sunshine Lake Pharma Co., Ltd) is FDA-approved and listed on DailyMed, so buyers specifying an INN-only tender line have a licensed generic option alongside Tradjenta; M Care can quote either against a purchase order.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, linagliptin carries none of the cold-chain documentation burden of injectable diabetes products: no time-out-of-refrigeration logs, no cold-chain validated lane requirement, just standard GDP-compliant ambient transport and storage records. M Care's CTD/eCTD dossier authoring support covers registration filings where a destination market requires local dossier submission ahead of tender participation.
On brand versus generic: Tradjenta remains the Boehringer Ingelheim-marketed product, and supply of the brand runs through licensed Indian distribution channels rather than a manufacturing line, consistent with M Care's role as a merchant exporter. A generic linagliptin tablet is FDA-approved and available through WHO-GMP manufacturing partner sites; M Care holds no manufacturing licence or WHO-GMP certification of its own and sources against the buyer's specification. Buyers choosing between brand and generic should confirm which their tender or formulary specification requires; M Care sources against either instruction and does not default to one over the other without a purchase order stating the requirement.
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 linagliptin.
Dapagliflozin
Another diabetes & endocrine line ordered on the same formularies.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Dulaglutide
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 linagliptin.
- 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.
Linagliptin supply, the specific questions.
Is there a generic version of linagliptin?
Yes. A generic linagliptin film-coated tablet is FDA-approved and listed on DailyMed, alongside the originator Tradjenta from Boehringer Ingelheim. M Care can source either against a confirmed purchase order; tell us which your tender or formulary specifies.
Does linagliptin require a cold chain?
No. Tradjenta and generic linagliptin are film-coated tablets stored at 20C to 25C (68F to 77F), with excursions to 15C to 30C permitted. Standard ambient GDP transport and warehousing apply, no cold-chain validated lane is needed.
Does linagliptin need dose adjustment for kidney impairment?
No. Both the FDA and EU labels state no dose adjustment is required for patients with renal impairment, without a stage-based cut-off, because linagliptin clears predominantly through the enterohepatic route rather than the kidneys. This differs from most other DPP-4 inhibitors.
Can M Care supply Tradjenta to our market?
Yes. M Care sources Tradjenta through licensed Indian distribution channels of the originator on an import basis; we are a merchant exporter and do not manufacture the product or hold WHO-GMP certification ourselves. Confirm your market's import and registration requirements and we will structure the order accordingly.
What strength does Tradjenta come in?
A single marketed strength: 5 mg film-coated tablets, dosed once daily, with or without food, per the FDA label and the EMA-authorised Trajenta product information.
What is linagliptin indicated for?
As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, per the FDA label. The EMA-authorised Trajenta adds specific positioning as monotherapy when metformin is inappropriate due to intolerance or contraindicated due to renal impairment, and in combination with other diabetes medicines, including metformin, a sulphonylurea, or insulin.
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.