Ranexa (ranolazine) is licensed as add-on therapy for chronic angina that is not adequately controlled on first-line antianginals, and FDA-approved generic ranolazine extended-release tablets are now on the market alongside it.
Ranexa (ranolazine), originated by CV Therapeutics and now marketed by Gilead Sciences in the US and by Menarini in Europe, is an oral antianginal taken alongside beta-blockers, calcium channel blockers or nitrates when angina symptoms persist. M Care Exports is a merchant exporter: we source Ranexa and FDA-approved generic ranolazine extended-release tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Ranolazine exporter and bulk supplier from India.
For hospital cardiology pharmacies, wholesaler and tender-desk orders, M Care quotes ranolazine extended-release tablets against buyer specification: brand (Ranexa) or generic, pack size, strength (500mg or 1000mg for the US-labelled dose range; 375mg, 500mg or 750mg where a market follows the EU titration schedule) and destination-market regulatory documentation. Because ranolazine is contraindicated with strong CYP3A inhibitors and inducers and needs dose limits with moderate CYP3A inhibitors, we confirm the buyer's intended co-prescribing pattern is on file 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.
Piperazine-derivative antianginal; late inward sodium current (INa) inhibitor, sourced and documented for export.
Ranolazine is a piperazine-derivative antianginal that inhibits the late inward sodium current in cardiac myocytes, reducing intracellular calcium overload and myocardial wall tension without significantly lowering heart rate or blood pressure. That mechanism sets it apart from beta-blockers, calcium channel blockers and nitrates, which is why it is used on top of them rather than instead of them.
In the US, Ranexa is FDA-labelled for chronic angina and dosed from 500mg twice daily up to a maximum of 1000mg twice daily. In the EU, Ranexa carries a narrower add-on licence, for patients inadequately controlled or intolerant on first-line antianginal therapies, titrated from 375mg twice daily up to a maximum of 750mg twice daily. Buyers should quote against their own market's approved dose range, not assume the two are interchangeable.
Ranexa and generic ranolazine are supplied as film-coated extended-release tablets, swallowed whole, not crushed, broken or chewed, and taken with or without food. It is a solid oral dosage form stored at controlled room temperature, not a cold-chain product, which simplifies freight compared with the biologics and injectables M Care also handles.
Active ingredient
ranolazine. Piperazine-derivative antianginal; late inward sodium current (INa) inhibitor.
Forms and strengths
375 mg extended-release film-coated tablet; 500 mg extended-release film-coated tablet; 750 mg extended-release film-coated tablet; 1000 mg extended-release film-coated tablet.
Indications
Oral antianginal indicated as add-on therapy for chronic angina inadequately controlled on first-line agents (beta-blockers, calcium channel blockers, nitrates). Reduces angina frequency without significantly affecting heart rate or blood pressure.
Administration
oral. Film-coated extended-release tablet, swallowed whole.
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 ranolazine are mainly hospital cardiology and cardiac-rehabilitation pharmacies, national and regional MoH tender desks running cardiovascular procurement lists, licensed pharmaceutical wholesalers and importers serving cardiac centres, and private hospital groups in markets where chronic angina is managed on a multi-drug regimen alongside beta-blockers and nitrates.
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 ranolazine.
US and EU dosing for ranolazine are not the same regimen, and a tender specification should say which one it is quoting against: the US label starts at 500mg twice daily and titrates to a 1000mg twice-daily ceiling, while the EU label starts lower, at 375mg twice daily, and titrates over 2 to 4 weeks to a 750mg twice-daily ceiling, with lower doses recommended in patients under 60kg or with renal, hepatic or cardiac impairment.
Ranolazine is contraindicated with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, certain HIV protease inhibitors) and with CYP3A4 inducers (rifampin, phenytoin, carbamazepine, St John's Wort), because both push exposure outside the safe range; moderate CYP3A4 inhibitors such as diltiazem and verapamil require capping the dose at 500mg twice daily. A documented 2023 case report describes ranolazine toxicity, including altered mental status, in a patient co-prescribed nirmatrelvir/ritonavir (Paxlovid) for COVID-19, caused by ritonavir's inhibition of the same CYP3A4 pathway, so a co-medication check belongs in the dispensing workflow, not just the initial prescription.
Ranolazine prolongs the QTc interval in a dose-related manner, so it is avoided or used cautiously alongside other QT-prolonging agents. It is contraindicated in clinically significant hepatic impairment, and plasma levels rise meaningfully with even mild hepatic dysfunction. Counsel patients to swallow tablets whole; splitting or crushing defeats the extended-release matrix. No reconstitution or cold-chain handling is required.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, ranolazine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics. What buyers need instead is confirmation of the correct strength-and-dosing schedule for their market (US-pattern 500mg/1000mg versus EU-pattern 375/500/750mg), plus the usual import licence, certificate of analysis and batch documentation M Care compiles for every shipment.
On the brand-versus-generic question, Ranexa remains the originator product, developed by CV Therapeutics and marketed by Gilead Sciences in the US since CV Therapeutics was acquired in 2009, and by Menarini in Europe under the same brand (previously registered as Latixa before the EMA approval carried the Ranexa name forward). FDA-approved generic ranolazine extended-release tablets, including Glenmark's (ANDA211082) and Teva's, are separately registered and marketed in the US in the 500mg and 1000mg strengths, so buyers genuinely have a brand-or-generic choice on that market's dosing schedule; M Care quotes either against the tender specification and destination-market registration status, since generic availability and dosing conventions can differ by country.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed 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.
Adjacent lines procurement desks order alongside ranolazine.
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 ranolazine.
- 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.
Ranolazine supply, the specific questions.
Does a generic version of Ranexa exist?
Yes. FDA-approved generic ranolazine extended-release tablets, in 500mg and 1000mg strengths, are registered and marketed in the US alongside Gilead's Ranexa, including lines from Glenmark and Teva. Registration status for generic ranolazine varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Ranexa to our market?
Yes, on an import basis. We source Ranexa through the originator's licensed Indian distribution channels and dispatch against your import authorisation and destination-market registration requirements.
What strengths of ranolazine are available, and does the dosing schedule differ by market?
Yes, and this matters for the quote. The US-labelled range is 500mg and 1000mg extended-release tablets, dosed twice daily up to a 1000mg twice-daily ceiling. The EU-labelled range is 375mg, 500mg and 750mg, titrated over 2 to 4 weeks up to a 750mg twice-daily ceiling. Tell us which dosing pattern your market follows and we quote the matching strength mix.
What documentation does M Care provide with a ranolazine shipment?
CTD/eCTD-aligned dossier documentation, certificates of analysis, batch records and CDSCO export paperwork from the Indian side, plus confirmation that the strength mix matches your destination market's approved dosing schedule.
Does ranolazine need cold-chain shipping?
No. It is an oral extended-release tablet stored at controlled room temperature, so it moves on standard ambient logistics rather than the validated cold-chain lanes M Care uses for biologics and vaccines.
What is ranolazine licensed to treat?
It is licensed as add-on antianginal therapy for chronic angina in patients not adequately controlled, or intolerant, on first-line agents such as beta-blockers, calcium channel blockers or nitrates. It reduces angina frequency and improves exercise tolerance without significantly lowering heart rate or blood pressure. Check your destination-country labelling for the exact licensed wording, since the US and EU indications are not phrased identically.
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.
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