Vastarel (trimetazidine) is licensed only as add-on therapy for stable angina pectoris in patients inadequately controlled by or intolerant to first-line antianginals, and buyers can specify the Servier brand or a licensed generic modified-release tablet against the same tender line.
Vastarel (trimetazidine), originated by Les Laboratoires Servier, is an oral anti-ischaemic metabolic agent that shifts myocardial energy production from fatty-acid oxidation towards glucose oxidation, cutting the heart's oxygen demand without the blood-pressure or heart-rate effects of a beta-blocker or nitrate. M Care Exports is a merchant exporter: we source Vastarel and licensed generic trimetazidine modified-release tablets through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Trimetazidine exporter and bulk supplier from India.
Tell us the strength (20mg immediate-release tablet, 35mg modified-release tablet, or 20mg/3mL oral drop solution), pack size, brand-or-generic preference and destination market, and we quote against your specification, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because trimetazidine's licence was narrowed by EU regulators in 2012 to second-line add-on therapy only, we confirm the exact indication a tender or formulary line specifies before we release a quote, 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.
Anti-ischaemic metabolic agent; fatty-acid oxidation (3-ketoacyl-CoA thiolase) inhibitor, sourced and documented for export.
Trimetazidine is an anti-ischaemic metabolic agent, not a haemodynamic one: it inhibits long-chain 3-ketoacyl-CoA thiolase, blocking beta-oxidation of fatty acids so the ischaemic myocardium switches to the less oxygen-hungry route of glucose oxidation, preserving intracellular ATP without altering heart rate or blood pressure. Its current licensed indication, narrowed by the European Medicines Agency in 2012, is add-on therapy for the symptomatic treatment of stable angina pectoris in adults inadequately controlled by, or intolerant to, first-line antianginal therapies; earlier indications for tinnitus, vertigo and visual disturbance were withdrawn for insufficient evidence. It is not indicated for unstable angina, myocardial infarction, or use in the pre-hospital phase. Vastarel is supplied as a 35mg modified-release film-coated tablet dosed twice daily with meals, alongside a 20mg immediate-release tablet and a 20mg/3mL oral drop solution (60 drops) used in some markets. Trimetazidine is not approved by the US FDA and is not marketed in the United States; the originator brand's core markets are the EU, GCC and wider MENA region, alongside licensed generic modified-release tablets from European generic manufacturers.
Active ingredient
trimetazidine dihydrochloride. Anti-ischaemic metabolic agent; fatty-acid oxidation (3-ketoacyl-CoA thiolase) inhibitor.
Forms and strengths
20 mg tablet; 35 mg modified-release film-coated tablet; 20 mg per 3mL oral drop solution (60 drops).
Indications
Oral anti-ischaemic metabolic agent licensed as add-on therapy for stable angina pectoris inadequately controlled by, or intolerant to, first-line antianginal treatments, following the EU's 2012 restriction of its earlier, broader licence.
Administration
oral. Modified-release film-coated tablet, immediate-release tablet and oral drop solution.
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 trimetazidine are cardiology and general-medicine hospital pharmacists managing patients on layered antianginal regimens, MoH tender desks in GCC and MENA markets where Vastarel has long formulary presence as an established second-line option, licensed pharmaceutical wholesalers and importers serving outpatient cardiac clinics, and regulatory affairs teams confirming which named product (brand or a specific generic modified-release line) a tender actually specifies before registration. Because trimetazidine sits on the WADA Prohibited List as a metabolic modulator, sports-medicine and anti-doping-adjacent institutional buyers also occasionally raise chain-of-custody and end-use questions that M Care can address in the documentation pack.
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 trimetazidine.
Trimetazidine dosing is renal-adjusted, not fixed: the standard 35mg modified-release tablet is taken twice daily with meals, but patients with moderate renal impairment (creatinine clearance 30-60mL/min), including most patients over 75, take a single 35mg tablet at breakfast only, and severe renal impairment (creatinine clearance below 30mL/min) is an outright contraindication. Elderly patients carry higher plasma exposure from age-related renal decline, so titrate cautiously and flag age and renal function on every dispensing record. The clinically distinctive risk to counsel on is drug-induced parkinsonism: tremor, akinesia, hypertonia, restless leg syndrome or gait instability warrant definitive withdrawal, and most cases resolve within four months, though a persistent case needs neurology referral. Trimetazidine is a solid oral dosage form on standard ambient, moisture-controlled logistics stored below 30°C, not a cold-chain product, with a three-year shelf life from the manufacturer. Flag to sports-medicine-adjacent institutional buyers that trimetazidine is a WADA-prohibited metabolic modulator at all times, in- and out-of-competition.
The documentation pack a regulator actually asks for.
Trimetazidine's defining regulatory event is the EMA's 2012 Article 31 safety review, which withdrew its indications for tinnitus, vertigo and visual disturbance, restricted the remaining stable-angina indication to second-line add-on therapy, and added contraindications for Parkinson's disease, parkinsonian symptoms, tremor, restless leg syndrome and severe renal impairment. Buyers running an EU, GCC or MENA tender should quote against that current label, not older marketing claims. On brand-versus-generic, Vastarel remains the Servier originator; the EMA's own referral file confirms multiple licensed generic trimetazidine 35mg modified-release products (assessed under mutual-recognition and Article 29 referrals such as Trimetazidine ratiopharm) are separately registered across EU member states, so buyers genuinely have a brand-or-generic choice, though we always confirm which named product a formulary line specifies. Trimetazidine is not approved by the US FDA and does not appear on the WHO Model List of Essential Medicines; it is not a controlled or scheduled substance, but it is a WADA-prohibited metabolic modulator, a detail worth flagging on any pharmacovigilance or end-use declaration.
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 trimetazidine.
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 trimetazidine.
- 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.
Trimetazidine supply, the specific questions.
What is trimetazidine (Vastarel) licensed to treat?
Its current licensed indication is add-on therapy for the symptomatic treatment of stable angina pectoris in adults who are inadequately controlled by, or intolerant to, first-line antianginal therapies. It is not indicated for unstable angina, myocardial infarction, or as an initial or pre-hospital treatment. Earlier indications for tinnitus, vertigo and visual disturbance were withdrawn by EU regulators in 2012 for insufficient evidence, so any tender or formulary line referencing those uses is out of date.
Why was trimetazidine's licence restricted in 2012?
The European Medicines Agency reviewed trimetazidine-containing medicines and concluded the benefit-risk balance no longer supported its broader historical uses. It withdrew the tinnitus, vertigo and visual-disturbance indications, narrowed the angina indication to second-line add-on therapy, and added contraindications for Parkinson's disease, parkinsonian symptoms, tremor, restless leg syndrome and severe renal impairment. M Care quotes against the current, post-2012 label.
Who should not take trimetazidine?
It is contraindicated in patients with Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome and related movement disorders, and in severe renal impairment (creatinine clearance below 30mL/min). Moderate renal impairment and age over 75 require a reduced, once-daily morning dose rather than outright avoidance. Movement-disorder symptoms that emerge during treatment should prompt definitive withdrawal and, if persistent, neurology referral.
Is trimetazidine available as a generic, or only as the Vastarel brand?
Both. Vastarel is the Servier originator, and licensed generic trimetazidine 35mg modified-release tablets are separately registered by other manufacturers across EU member states through mutual-recognition referrals. Buyers can specify brand or generic; M Care confirms exactly which named product a tender or formulary line requires before quoting.
Does trimetazidine need cold-chain shipping?
No. Vastarel tablets and oral solution are stored below 30°C on standard ambient, moisture-controlled logistics, not the validated cold-chain lanes M Care runs for biologics, and carry a three-year shelf life from the manufacturer.
Why does trimetazidine appear on anti-doping lists, and does that affect supply?
Trimetazidine is classified by the World Anti-Doping Agency as an S4 metabolic modulator, prohibited at all times, in- and out-of-competition, because its metabolic effects have been misused by athletes. This has no bearing on its legitimate use as a cardiology medicine, but institutional buyers with sports-medicine adjacency sometimes ask for end-use and chain-of-custody documentation, which M Care can include in the standard shipping pack.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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.