Prandin (repaglinide), sold internationally as NovoNorm, is licensed as an adjunct to diet and exercise for glycaemic control in adults with type 2 diabetes, dosed before each meal, and FDA-approved generic repaglinide tablets are available alongside the Novo Nordisk brand.
Prandin (repaglinide), from Novo Nordisk and marketed outside the US as NovoNorm, is a short-acting oral meglitinide taken before each meal to control post-prandial glucose in type 2 diabetes. M Care Exports is a merchant exporter: we source the Novo Nordisk brand and FDA-approved generic repaglinide tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Repaglinide exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes repaglinide tablets against buyer specification: brand (Prandin/NovoNorm) or generic, strength mix (0.5 mg, 1 mg, 2 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because repaglinide carries a hard contraindication with gemfibrozil, we confirm the buyer's intended formulary co-listing and counselling materials before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Meglitinide; non-sulfonylurea, short-acting prandial insulin secretagogue, sourced and documented for export.
Repaglinide is a meglitinide, a non-sulfonylurea insulin secretagogue that closes ATP-sensitive potassium channels on pancreatic beta cells to trigger a rapid, short-lived burst of insulin release timed to a meal, rather than the sustained stimulation a sulfonylurea produces. It is dosed orally, not injected, and needs no reconstitution. Prandin's FDA-labelled indication is as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus; it is not indicated for type 1 diabetes or diabetic ketoacidosis. NovoNorm's EU indication is the same disease area and extends to use in combination with metformin for patients inadequately controlled on metformin alone. Destination-country labelling should be checked against this before a tender quote is finalised. Prandin/NovoNorm is supplied as 0.5 mg, 1 mg and 2 mg tablets, taken within 30 minutes before each main meal.
Active ingredient
repaglinide. Meglitinide; non-sulfonylurea, short-acting prandial insulin secretagogue.
Forms and strengths
0.5 mg tablet; 1 mg tablet; 2 mg tablet.
Indications
Short-acting oral meglitinide indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, dosed per meal rather than per day, and contraindicated with gemfibrozil.
Administration
oral. Tablet, taken within 30 minutes before each main meal.
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 repaglinide are mainly hospital and community diabetes pharmacies serving patients with irregular meal patterns or renal impairment where sulfonylurea hypoglycaemia risk is a concern, national and regional MoH tender desks running diabetes formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting diabetes-care access in markets where local registration is in place.
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 repaglinide.
Repaglinide is dosed per meal, not per day: 0.5 mg to 4 mg taken within 30 minutes before each main meal, doubled at intervals of at least a week based on blood glucose response, to a maximum of 16 mg daily. The counselling point that matters most at dispensing is the skip rule: if a meal is skipped, the dose is skipped, since repaglinide's rapid onset and short half-life make it a genuinely prandial agent rather than a background insulin secretagogue. This is the clinical case for choosing it over a sulfonylurea in patients with erratic meal timing or renal impairment, where prolonged hypoglycaemia from a longer-acting secretagogue is a real risk. Gemfibrozil co-administration is contraindicated outright: combined dosing raised repaglinide exposure roughly eightfold in the FDA label's pharmacokinetic data, and adding itraconazole pushed that to around nineteenfold. Medicines reconciliation should flag any fibrate on the patient's record before repaglinide is dispensed. Hepatic impairment also warrants caution, with longer intervals between dose titrations; severe renal impairment needs a cautious 0.5 mg start.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, repaglinide travels on standard ambient-temperature logistics rather than the cold-chain lanes we validate for insulins and GLP-1 biologics. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Repaglinide does not appear among the oral glucose-lowering agents on the current WHO Model List of Essential Medicines, which lists metformin, sulfonylureas and, since the 2025 update, short-acting insulin analogues and GLP-1 agents for type 2 diabetes; repaglinide functions as a second-line, formulary-specific option rather than an EML first-line agent, which buyers should factor into tender specification. On the brand-versus-generic question, Prandin/NovoNorm remains the originator product from Novo Nordisk, sourced through Novo Nordisk's licensed Indian distribution channels. FDA-approved generic repaglinide tablets from multiple manufacturers, including Aurobindo, are also separately registered, so buyers genuinely have a brand-or-generic choice; M Care quotes either against the tender specification and destination-market registration status. Buyers in the UK should also note that repaglinide 0.5 mg and 1 mg tablets faced an out-of-stock supply notification from late August to early December 2025, with 2 mg tablets in constrained supply over the same period, which we treat as a live example of why formulary desks keep a secondary export source on file.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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 repaglinide.
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 repaglinide.
- 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.
Repaglinide supply, the specific questions.
Does a generic version of Prandin/NovoNorm exist?
Yes. FDA-approved generic repaglinide tablets are registered and marketed in the US alongside Novo Nordisk's Prandin, including from manufacturers such as Aurobindo. Registration status for generic repaglinide varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Prandin or NovoNorm to our market?
Yes, on an import basis. We source Prandin/NovoNorm through Novo Nordisk's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy or hospital holds.
What strengths of repaglinide tablets are available?
0.5 mg, 1 mg and 2 mg tablets, matching the Prandin/NovoNorm strengths. Tell us your dosing protocol and meal-pattern population and we quote the strength mix accordingly.
Why choose repaglinide over a sulfonylurea for some patients?
Repaglinide is dosed per meal and skipped if a meal is skipped, which suits patients with irregular eating patterns or renal impairment, where a longer-acting sulfonylurea carries a higher risk of prolonged hypoglycaemia. It is not on the WHO Essential Medicines List, so tender desks typically specify it as a formulary-specific second-line option rather than a first-line agent.
Is repaglinide safe to co-prescribe with gemfibrozil?
No. Co-administration with gemfibrozil is contraindicated on the FDA label: combined dosing raised repaglinide exposure roughly eightfold in pharmacokinetic studies, and adding itraconazole increased that further. Medicines reconciliation should check for any fibrate before dispensing.
What documentation does M Care provide with a repaglinide shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
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.