Vildagliptin's EU label requires a liver function test before treatment starts, then testing every three months through the first year, with a defined threshold for stopping therapy.
Vildagliptin's EU labelling ties its use to a fixed liver monitoring schedule: a liver function test before treatment begins, testing at three-month intervals through the first year, and periodic testing after that, with withdrawal recommended if ALT or AST elevation of three times the upper limit of normal persists. Vildagliptin is contraindicated in hepatic impairment, including anyone whose pre-treatment ALT or AST already sits above that threshold. That schedule is a dossier and patient-information requirement for the treating market, and it is one that a buyer registering or tendering this molecule has to plan for directly. M Care supplies vildagliptin 50mg tablets, thirty-five stocked lines, sourced from WHO-GMP certified Indian manufacturers, to regulatory teams and procurement desks building files for markets across the EU, UK, Gulf, Africa, Latin America, Southeast Asia and the CIS.
Vildagliptin exporter and bulk supplier from India.
M Care's vildagliptin catalogue is 50mg oral tablets only, thirty-five stocked lines supplied as monotherapy stock keeping units and sourced from WHO-GMP certified Indian manufacturers. The catalogue carries no fixed-dose combination lines and no injectable, capsule or oral suspension presentations, so buyers requiring a vildagliptin-metformin combination or a non-tablet form should raise that requirement separately rather than assume it is stocked. Each shipment is supported by a certificate of analysis against the manufacturer's approved specification, a certificate of pharmaceutical product or free sale certificate for destination registration, and batch-wise GMP documentation from the manufacturing site. Because the liver function testing schedule attached to this molecule is a labelling and prescribing obligation for the treating market, buyers building a registration or tender file should plan for it in the product monograph and patient information they submit, separately from the batch documentation M Care provides.
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, oral antihyperglycemic agent, sourced and documented for export.
Vildagliptin carries a mandatory liver function testing schedule under its EU labelling: a baseline test before treatment starts, testing at three-month intervals through the first year, and periodic testing after that. The label sets a defined stopping point, if ALT or AST rises to three times the upper limit of normal and stays there, withdrawal of therapy is recommended, and jaundice or other signs of liver dysfunction call for immediate discontinuation. Vildagliptin is contraindicated in hepatic impairment, including anyone with a pre-treatment ALT or AST above that same threshold. It is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in adults with type 2 diabetes mellitus, as monotherapy or alongside other antidiabetic agents including metformin, when glycaemic control is inadequate.
Active ingredient
Vildagliptin. Dipeptidyl peptidase-4 (DPP-4) inhibitor, oral antihyperglycemic agent.
Forms and strengths
50 mg.
Indications
Vildagliptin is an orally administered dipeptidyl peptidase-4 (DPP-4) inhibitor used in adults with type 2 diabetes mellitus, as monotherapy where metformin is unsuitable or alongside other antidiabetic agents including metformin, to improve glycaemic control when diet and exercise alone are inadequate. It is contraindicated in patients with hepatic impairment and carries a mandatory liver function monitoring schedule under its European labelling: a baseline test before initiation, testing at three-month intervals through the first year, and periodic testing thereafter, with withdrawal recommended if ALT or AST elevation of three times the upper limit of normal persists.
Administration
Oral. 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 vildagliptin 50mg tablets are regulatory affairs teams and procurement desks assembling a registration file that must account for the molecule's mandatory liver function testing schedule, across markets that register against an EU or WHO-model dossier rather than an FDA-approved reference listed drug. That includes hospital and tender procurement across the Gulf and GCC, ministry-of-health tenders and licensed importers across Sub-Saharan and North Africa, distributors in Latin America, and licensed pharmaceutical importers across Southeast Asia and the CIS. UK and EU generic applicants also work from vildagliptin's EMA-anchored innovator dossier. M Care does not supply the United States, and does not supply India, which is a country of manufacture only, not a served market.
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 vildagliptin.
A pharmacist reviewing a vildagliptin registration or import file checks the hepatic contraindication first: vildagliptin should not be used in patients with hepatic impairment, including anyone with pre-treatment ALT or AST above three times the upper limit of normal. The EU label requires a liver function test before initiation, at three-month intervals through the first year of treatment, and periodically after that, with withdrawal recommended if AST or ALT elevation of three times the upper limit persists, and immediate discontinuation on jaundice or other signs of hepatic dysfunction. That schedule needs to be reflected in the product monograph and patient information the buyer's regulatory team submits, not assumed from the innovator's file alone. Combination use with a sulfonylurea or insulin carries the expected added hypoglycaemia risk and should be checked against that partner's own label.
The documentation pack a regulator actually asks for.
M Care is not a manufacturer and holds no WHO-GMP or WHO-PQ certification of its own; it operates as a merchant-exporter under ISO 9001:2015 with a CDSCO export licence, sourcing vildagliptin tablets from WHO-GMP certified Indian manufacturing sites and passing through the manufacturer's own regulatory file rather than generating one. No FDA-approved reference product exists for vildagliptin, so importers across most of M Care's served markets, the EU, UK, Gulf, Africa, Latin America, Southeast Asia and CIS, build registration dossiers against the EMA-authorised innovator or a WHO-model Certificate of Pharmaceutical Product rather than an Orange Book listing. The mandatory liver function testing schedule set out in the EU label, baseline before treatment, three-monthly through year one, periodic thereafter, is part of that dossier and the product's patient information, and it is the buyer's regulatory team that carries it forward into the destination file. The documentation pack available per shipment includes batch-wise certificates of analysis, the manufacturer's GMP certificate, and free sale or CPP certificates suited to that dossier route.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Contraindicated in patients with hepatic impairment, including anyone with pre-treatment ALT or AST greater than three times the upper limit of normal.
Mandatory liver function test monitoring required under EU labelling: baseline before treatment starts, three-monthly through the first year, periodically thereafter; withdrawal of therapy recommended if AST or ALT elevation of three times the upper limit persists, or immediately on jaundice or other signs of liver dysfunction.
No FDA-approved reference product exists for vildagliptin; it is not marketed in the United States.
M Care is a merchant-exporter, not a manufacturer; holds ISO 9001:2015 certification and a CDSCO export licence only, no WHO-GMP or WHO-PQ certification of its own.
India is M Care's country of manufacture and export origin only, never a served market.
Catalogue is monotherapy 50mg oral tablets only; no fixed-dose combination, capsule, injectable, oral suspension, topical, ophthalmic, inhaled or sachet presentations are stocked.
Adjacent lines procurement desks order alongside vildagliptin.
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 vildagliptin.
- 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.
Vildagliptin supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant-exporter, not a manufacturer, and holds ISO 9001:2015 certification and a CDSCO export licence. Vildagliptin tablets are sourced from WHO-GMP certified Indian manufacturing sites, and the WHO-GMP certificate accompanying a shipment belongs to that manufacturer, not to M Care.
What liver function monitoring does vildagliptin's label require?
Vildagliptin's EU labelling requires a liver function test before treatment starts, testing at three-month intervals through the first year, and periodic testing after that. If ALT or AST rises to three times the upper limit of normal and stays there, withdrawal of therapy is recommended, and jaundice or other signs of liver dysfunction call for immediate discontinuation. The label does not specify a fixed interval for periodic testing beyond the first year.
Why is vildagliptin contraindicated in hepatic impairment, and does that affect how M Care documents a shipment?
Vildagliptin should not be used in patients with hepatic impairment, including anyone with a pre-treatment ALT or AST above three times the upper limit of normal. That is a prescribing and monitoring requirement for the treating market, built into the product's registration dossier and patient information; M Care's documentation covers batch quality and export compliance, not clinical monitoring.
Does M Care supply vildagliptin-metformin fixed-dose combination tablets?
No. The current catalogue is monotherapy vildagliptin 50mg tablets only, across thirty-five stocked lines, with no fixed-dose combination lines held in stock. Buyers requiring a vildagliptin-metformin combination, or a capsule, injectable or oral suspension presentation, should raise that requirement directly so it can be sourced separately.
Which strengths of vildagliptin does M Care stock?
M Care stocks vildagliptin 50mg oral tablets, which is also the only strength in which vildagliptin is marketed anywhere. There is no higher- or lower-strength tablet to source, so buyers requesting an alternate strength should confirm that requirement before placing an order.
Does M Care ship vildagliptin to India?
No. India is M Care's country of manufacture and export origin, not a served market. M Care supplies regulated importers, hospital and tender procurement, and licensed distributors across the EU, UK, Gulf and GCC, Africa, Latin America, Southeast Asia and the CIS.
What documentation accompanies a vildagliptin export shipment?
Each shipment carries a certificate of analysis against the manufacturer's specification, the manufacturer's WHO-GMP certificate, and a free sale certificate or certificate of pharmaceutical product suited to the importing market's dossier. The liver function testing schedule and hepatic contraindication belong in the product's registration file and patient information, which the importer or its regulatory partner assembles separately from M Care's batch documentation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.