Metoprolol tartrate IR + succinate XL + IV, Indian WHO-GMP supply for hypertension, angina, heart failure and use after myocardial infarction.
Cardioselective beta-1 adrenergic antagonist supplied as both salt forms: metoprolol tartrate (twice-daily immediate-release) and metoprolol succinate (once-daily prolonged-release). The heart failure indication in the US Toprol-XL label rests on the MERIT-HF trial, which was terminated early for a 34% reduction in all-cause mortality. 25mg, 50mg, 100mg IR tartrate; 25mg, 50mg, 100mg, 200mg succinate XL; 1mg/ml IV ampoules. On the WHO Model List of Essential Medicines as a therapeutic alternative to bisoprolol.
Also marketed as Lopressor, Toprol-XL and Kapspargo.
Metoprolol exporter and bulk supplier from India.
M Care Exports supplies bulk Metoprolol, Cardioselective (beta-1 selective) beta-adrenergic receptor antagonist, to importers, distributors and tender buyers across 49+ export markets, sourced from WHO-GMP-certified Indian manufacturers. We are not the manufacturer; we place your order with the source line that best fits your market and name it on every quote.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route.
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.
Both salt forms available · 8 strengths across tartrate IR, succinate XL and IV ampoules · MERIT-HF mortality evidence for the succinate XL salt.
Active ingredient and mechanism
Metoprolol, cardioselective beta-1 adrenergic receptor antagonist. The UK SmPC contraindicates use in severe bronchial asthma or COPD. Supplied as two distinct salt forms: tartrate (twice-daily IR, 3-4 hour half-life) and succinate (once-daily prolonged-release; the Toprol-XL label describes a multiple-unit system of controlled-release pellets). The salts are not interchangeable for heart failure dosing because the MERIT-HF mortality evidence applies specifically to succinate CR/XL. M Care does not hold FDA or TGA registrations for this molecule.
Strengths available
Tartrate IR film-coated tablets: 25mg, 50mg and 100mg. Succinate prolonged-release tablets: 25mg, 50mg, 100mg and 200mg. IV solution: 1mg/ml metoprolol tartrate in 5ml glass ampoules. All tablets supplied as scored or unscored film-coated per market specification, in HDPE bottles or destination-language blister packaging.
Indications scope
The UK SmPC for metoprolol tartrate tablets lists hypertension, angina pectoris, tachycardiac arrhythmia (particularly supraventricular tachycardia), prevention of cardiac death and re-infarction after the acute phase of myocardial infarction, and prophylaxis of migraine. The US Toprol-XL label lists hypertension, angina pectoris and heart failure, and the heart failure indication is for the succinate salt. The UK Betaloc injection SmPC lists control of tachyarrhythmias, especially supraventricular tachyarrhythmias, and early IV use in acute myocardial infarction. The approved labelling of the line supplied governs.
Buyer fit
Hospital pharmacies and tender desks for IV ampoules and for oral tartrate and succinate tablets, supplied through licensed importers. Registration and import sit with the destination regulator, for example SFDA (Saudi Arabia), the Emirates Drug Establishment (UAE), NAFDAC (Nigeria), PPB (Kenya), SAHPRA (South Africa), EFDA (Ethiopia) and TMDA (Tanzania).
What we file with the quote
The source manufacturer's manufacturing licence (Form 25 or 28, issued by the state drug regulator) and WHO-GMP certificate, Certificate of Pharmaceutical Product (CoPP) per WHO format, issued by the state drug regulator, for the destination regulator, batch Certificate of Analysis (CoA) against the manufacturer's BP/USP/EP-aligned monograph, Summary of Product Characteristics (SmPC) per destination regulator's format, Patient Information Leaflet (PIL) with destination-language translation where required, CTD dossier modules and a bioequivalence study report where the source manufacturer holds them, set against the reference listed drug (Lopressor for tartrate, Toprol-XL for succinate in the US), and for IV ampoules a sterility certificate and bacterial endotoxin (LAL) results.
Lead times
Lead time depends on the source manufacturer's batch schedule for the strength and pack ordered, and is confirmed on the proforma. Larger tender quantities may need a dedicated manufacturing batch. Sea freight adds transit time that depends on the destination port; air freight is available for urgent orders. Check the storage statement of the product supplied; the UK Betaloc injection SmPC states no more than 25°C with ampoules protected from light.
Four buyer-channel models for a metoprolol pharmaceutical export from India
Pharmaceutical supply is not one channel. M Care services UK NHS, GCC government tenders, African public-sector procurement and EU/LATAM/SEA registered-market routes on different paperwork tracks. The MERIT-HF mortality evidence behind the heart failure indication in the Toprol-XL label is for the succinate salt, while the tartrate tablet SmPC covers hypertension, angina, arrhythmia, post-MI use and migraine prophylaxis.
UK NHS hospital and community pharmacy
The UK SmPCs on the electronic medicines compendium cover metoprolol tartrate 25mg, 50mg and 100mg tablets and Betaloc 1 mg/ml solution for injection (5 ml ampoules). M Care supplies UK WDA(H)-licensed wholesalers with batch CoA in BP-aligned format. Each imported batch needs certification by the importer's Qualified Person under the importer's own manufacturing/import authorisation, and we supply the manufacturer-side documents that review relies on.
GCC government tender supply
Gulf Health Council Central Registration route or state-by-state via SFDA (KSA), EDE (UAE), the Ministry of Health (Kuwait), MoPH (Qatar), the Drug Safety Center (Oman) and NHRA (Bahrain). SFDA requires the SPC in English and the PIL in Arabic and English, and the GCC stability guideline places the GCC states in climatic zones III and IVa.
African public-sector procurement
NAFDAC (Nigeria), PPB / KEMSA (Kenya), FDA Ghana, SAHPRA / NDoH (South Africa), EFDA / EPSS (Ethiopia), TMDA / MSD (Tanzania), NDA (Uganda) registration pathways. Sea-freight LCL/FCL via Mumbai / Nhava Sheva to Lagos / Mombasa / Durban / Dar es Salaam is the standard logistics lane, with FFP and pre-shipment QC sampling; transit time depends on the port and sailing schedule and is confirmed at booking.
EU and other regulated markets
EU member states through an importer holding the manufacturing/import authorisation, with QP batch certification of each imported batch; LATAM via ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru) registration pathways; SEA via Philippines FDA, Vietnam DAV, Indonesia BPOM, Malaysia NPRA, Bangladesh DGDA, Sri Lanka NMRA. M Care's role is dossier and tender-pack assembly, not manufacturing; partner manufacturers handle the API and finished dosage.
Tartrate vs succinate salt is not interchangeable for HFrEF, the MERIT-HF mortality evidence applies to the succinate CR/XL salt only.
Hypertension: the UK SmPC for metoprolol tartrate tablets gives an initial dose of 100 mg daily, increased to 200 mg daily in single or divided doses, and the Toprol-XL label gives a usual initial dosage of 25 to 100 mg daily in a single dose. Heart failure: the Toprol-XL label starts at 25 mg once daily for two weeks in NYHA class II heart failure and 12.5 mg once daily in more severe heart failure, doubling the dose every two weeks to the highest tolerated dose or up to 200 mg. The heart failure evidence in the label is for the succinate salt (MERIT-HF), so the two salts are not interchangeable for that indication. Switching from immediate-release metoprolol to Toprol-XL uses the same total daily dose (for example tartrate 50mg twice daily to succinate 100mg once daily), per the Toprol-XL label. Acute myocardial infarction: the Betaloc injection SmPC gives 5 mg IV every 2 minutes to a maximum of 15 mg, then oral 50 mg every 6 hours for 48 hours starting 15 minutes after the last injection; the tablet SmPC gives a maintenance dose of 100 mg twice daily. Arrhythmias: the tablet SmPC gives usual dosing of 100 to 200 mg daily. Contraindications in the UK tablet SmPC include second or third degree AV block, unstable or acute decompensated heart failure, clinically significant sinus bradycardia (below 50/min) or sick sinus syndrome, cardiogenic shock, severe peripheral arterial disease, hypotension, severe bronchial asthma or COPD, untreated phaeochromocytoma, and concomitant IV verapamil, diltiazem or disopyramide (except in intensive care). Bronchospasm: the Lopressor label says patients with bronchospastic disease should in general not receive beta-blockers, and the UK SmPC contraindicates severe bronchial asthma or COPD. Beta-blocker withdrawal syndrome, do not stop abruptly; the Lopressor label says to reduce the dosage gradually over 1 to 2 weeks and monitor the patient. Diabetes: beta-blockers may prevent early warning signs of hypoglycaemia such as tachycardia (Lopressor label). Drug interactions: CYP2D6 inhibitors (for example fluoxetine, paroxetine, bupropion, quinidine) may increase metoprolol plasma concentration and the dose may need reducing (UK SmPC); the Lopressor label says strong CYP2D6 inhibitors double metoprolol concentrations. Clonidine: withdraw the beta-blocker several days before the gradual withdrawal of clonidine (Lopressor label). IV verapamil, diltiazem or disopyramide are contraindicated in the UK SmPC except in intensive care. Pregnancy: the UK SmPC says metoprolol may only be used during pregnancy if the benefits to the mother outweigh the risk to the embryo or foetus, at the lowest possible dose. Breastfeeding: the UK SmPC says the concentration in breast milk is approximately three times that in maternal plasma, and breastfed babies should be monitored for signs of beta blockade. M Care does not provide clinical advice, local prescribing formulary, MHRA Drug Safety Updates and the destination-country regulator's SmPC are the prescribing references.
Five regulatory tracks for an Indian-manufactured metoprolol pharmaceutical export
Dossier content for a new market is assembled from the source manufacturer's CTD modules plus the country-specific Module 1. Tartrate and succinate have separate labels and indications (Lopressor and Toprol-XL in the US), so we treat them as separate products.
WHO Essential Medicines List
The WHO Model List of Essential Medicines (23rd edition, 2023) lists bisoprolol for angina, arrhythmia, hypertension and heart failure, with metoprolol and carvedilol as therapeutic alternatives. The list names metoprolol without specifying a salt.
MHRA (United Kingdom)
The UK SmPCs on the electronic medicines compendium cover metoprolol tartrate 25mg, 50mg and 100mg tablets and Betaloc 1 mg/ml solution for injection; the legal category is prescription only medicine.
EMA (European Union) and EU member states
Decentralised Procedure and Mutual Recognition Procedure registrations across EU/EEA run through national medicines agencies (BfArM Germany, AIFA Italy, AEMPS Spain, ANSM France, MEB Netherlands, INFARMED Portugal). Each batch imported from outside the EEA needs certification by the importer's Qualified Person under the importer's manufacturing/import authorisation.
GCC and Middle East
Gulf Health Council Central Registration route covering KSA, UAE, Kuwait, Qatar, Oman, Bahrain (separate filings for tartrate and succinate). State-by-state where Central Registration is not in scope: SFDA (KSA), EDE (UAE), Ministry of Health (Kuwait), MoPH (Qatar), Drug Safety Center (Oman), NHRA (Bahrain). SFDA requires the SPC in English and the PIL in Arabic and English.
African and LMIC markets
NAFDAC (Nigeria), PPB / KEMSA (Kenya), FDA Ghana, SAHPRA (South Africa), EFDA / EPSS (Ethiopia), TMDA / MSD (Tanzania), NDA (Uganda), Rwanda FDA registration pathways. SAHPRA's reliance pathway can shorten review where the same product is already approved by one of the reference authorities SAHPRA recognises; Indian approval alone does not qualify. Zone IVb stability data for destinations that set 30°C / 75% RH.
Pharmacovigilance and adverse-event reporting
Pharmacovigilance reporting runs through the UK Yellow Card scheme, EU EudraVigilance, the SFDA and NAFDAC, and sits with the marketing authorisation holder in each market rather than with M Care as a merchant exporter. Cautions in the labelling include bradycardia and heart block, bronchospasm in susceptible patients, masked hypoglycaemia and worsening angina on abrupt discontinuation.
Metoprolol's tender-line and clinical companion molecules
Cardiovascular tenders are rarely single-line. Metoprolol is listed here alongside related cardiovascular molecules. Internal links to the molecules and services already covered.
Amlodipine
Dihydropyridine calcium channel blocker, listed in the cardiovascular category alongside metoprolol.
Losartan
Angiotensin II receptor blocker, listed in the cardiovascular category alongside metoprolol.
Clopidogrel
Thienopyridine P2Y12 inhibitor, an antiplatelet used after myocardial infarction.
Atorvastatin
HMG-CoA reductase inhibitor (statin) used to lower cholesterol.
GCC tender response service
SFDA, NUPCO and state-by-state tender desks for metoprolol alongside the broader cardiovascular pack, with quotes on both tartrate and succinate salts.
EU-GMP import workflow
Metoprolol into Germany, France, Italy, Spain and the Netherlands through importers whose Qualified Person certifies each batch, with separate files for the tartrate and succinate salts.
How a metoprolol enquiry becomes a sustained supply contract
- Send us the specifics. WhatsApp the Mumbai line or send the contact form. We need the destination country, the salt form required (tartrate IR or succinate XL or both, single or multi-strength), strengths (25mg, 50mg, 100mg for tartrate IR; 25mg, 50mg, 100mg, 200mg for succinate XL; 1mg/ml IV ampoule for hospital protocols), the per-month or per-tender volume, the buyer profile (NHS framework, GCC tender desk, African MoH, NGO, EU community-pharmacy chain), and the indication (HFrEF tender requires succinate XL specifically). Reply within one working day with a provisional quote and a confirmation of which Indian partner manufacturer is best-fit for the salt and strength combination.
- Source-line quote. M Care names the source manufacturer line for each salt-and-dose combination on the quote. Pricing is FOB Mumbai or CIF destination port, packaged in destination-language blister or bottle per buyer specification. Quote includes per-tablet ex-works pricing, freight to destination, dossier preparation fee (if new registration), and any destination-country regulatory fees passed through at cost. IV ampoules quoted separately due to different campaign cadence and additional sterility certification.
- Dossier preparation. For existing registrations, M Care provides batch-specific CoA, CoPP per WHO format, bioequivalence study reports versus the destination reference listed drug, and SmPC/PIL country overlay once the destination is confirmed. For new-market registration, we assemble the full CTD Module 1-5 dossier, Module 3 quality data is partner-manufacturer-specific and reused across markets; Module 1 administrative is country-specific and re-overlaid per destination regulator (MHRA, EMA, SFDA, NAFDAC, PPB, SAHPRA, EFDA, TMDA). Tartrate and succinate are handled as separate files because they are different salts with different labelled indications. Review time is set by the destination regulator.
- Manufacturing campaign and freight. Lead time depends on the source manufacturer's batch schedule and is confirmed on the proforma. Air freight via Mumbai / Delhi for time-critical orders; sea freight LCL/FCL for tender volumes via Nhava Sheva. Destination customs clearance handled by buyer with M Care providing import-licence support paperwork (commercial invoice, packing list, CoA, CoPP, sterility certificate for IV ampoules).
- Ongoing supply and pharmacovigilance. Repeat orders follow the same quote and documentation route. Pharmacovigilance reporting (Yellow Card, EudraVigilance, SFDA, NAFDAC) is the responsibility of the marketing authorisation holder in each market, not of M Care as a merchant exporter.
Metoprolol tablet and IV supply, buyer FAQ
What strengths and salts of metoprolol does M Care supply?
We supply the full standard range. Metoprolol tartrate immediate-release film-coated tablets in 25mg, 50mg and 100mg. Metoprolol succinate prolonged-release tablets in 25mg, 50mg, 100mg and 200mg. Metoprolol tartrate intravenous solution 1mg/ml in 5ml ampoules for hospital use. Hospital pack sizes (10x10 blister), retail packs (3x10 blister) and bulk drum API on request. Quote your tender pack-size requirement and destination market and we revert with manufacturer options within 48 hours.
Are both metoprolol tartrate and metoprolol succinate available, and what is the difference?
Yes, both salts are available. Tartrate is the immediate-release salt (mean elimination half-life 3 to 4 hours per the Lopressor label), dosed twice daily in the UK SmPC regimens for angina and after myocardial infarction. Succinate is the once-daily prolonged-release salt. The heart failure indication in the Toprol-XL label rests on MERIT-HF, which tested the succinate salt, so a tender for heart failure should name the succinate salt explicitly. We document salt form on every batch CoA, label and pack.
Which destination markets accept WHO-GMP metoprolol generics from India?
We ship into the United Kingdom (through UK licensed importers), UAE (EDE and DHA registered importers), Saudi Arabia (SFDA marketing authorisation and NUPCO tenders), Nigeria (NAFDAC registration), Kenya (PPB and KEMSA tenders), South Africa (SAHPRA registered partners), Ethiopia (EFDA), Tanzania (TMDA) and Uganda (NDA). Each destination sets its own registration pathway, dossier format and stability-zone requirement, which we check at the manufacturer-selection stage.
What is the lead time for metoprolol shipments and minimum order quantity?
Lead time and minimum order quantity are set by the source manufacturer's batch schedule and minimum batch-release quantity for the strength and pack ordered, and are confirmed on the proforma. Sea-freight transit time depends on the destination port, and air freight is available for urgent orders.
Does M Care supply the IV metoprolol injection for hospital use?
Yes. Metoprolol tartrate IV 1mg/ml in 5ml glass ampoules is available on request for hospital supply through licensed importers. Documents are agreed per order and can include the batch CoA and the source batch's sterility and bacterial endotoxin results. The UK Betaloc 1 mg/ml SmPC states store at no more than 25 degrees Celsius with the ampoules kept in the outer carton to protect from light.
How do you handle the tartrate-versus-succinate bioequivalence question in tender substitutions?
The salts are not interchangeable for heart failure, because the Toprol-XL label carries the heart failure dosing and the MERIT-HF evidence for succinate. When switching from immediate-release metoprolol to Toprol-XL the label says to use the same total daily dose (for example tartrate 50mg twice daily to succinate 100mg once daily). We never substitute salt form without written customer authorisation. Tender bid documents specify the exact salt, strength, release profile and originator reference (Lopressor for tartrate, Toprol-XL for succinate) so procurement teams can validate equivalence with their clinical pharmacy.
Can M Care provide a Quality Overall Summary (Module 2.3) and full CTD dossier for metoprolol registration submissions?
Dossier content comes from the source manufacturer and varies by line. Where the manufacturer holds them, we pass on CTD modules such as Module 2.3 Quality Overall Summary, Module 3.2.S (drug substance), Module 3.2.P (drug product) and bioequivalence study reports versus the reference product, under a confidentiality agreement. Whether a dossier meets a regulator's requirements is for that regulator to decide.
Who stands behind this page.
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.
Metoprolol tartrate IR + succinate XL + IV, supply for hypertension, angina, heart failure and use after myocardial infarction.
Metoprolol is supplied as two distinct salt forms with different labelled indications. M Care is a merchant exporter: partner manufacturers make the product, and registration in each market is for the importer and that market's regulator.