Metoprolol tartrate IR + succinate XL + IV — Indian WHO-GMP supply for NICE NG106 HFrEF, post-MI secondary prevention, and atrial fibrillation rate control.
Cardioselective beta-1 adrenergic antagonist supplied as both salt forms: metoprolol tartrate (twice-daily immediate-release) and metoprolol succinate (once-daily prolonged-release). NICE NG106 first-line HFrEF beta-blocker per MERIT-HF trial (34% mortality reduction). NICE NG185 post-MI secondary prevention. NICE NG196 first-line atrial fibrillation rate control. NICE NG136 step 4 antihypertensive. 25mg, 50mg, 100mg IR tartrate; 25mg, 50mg, 100mg, 200mg succinate XL; 1mg/ml IV ampoules for acute coronary syndrome protocols. Both salts on the WHO Essential Medicines List core list.
Both salt forms stocked · 8 strengths across tartrate IR, succinate XL and IV ampoules · CTD dossier on file · NHS NG106 first-line HFrEF · MERIT-HF mortality evidence for the succinate XL salt.
Active ingredient and mechanism
Metoprolol — cardioselective beta-1 adrenergic receptor antagonist. Mechanism: selective competitive inhibition of beta-1 receptors in cardiac myocytes reduces heart rate, contractility, AV nodal conduction and renin release. Beta-2 selectivity preserved at therapeutic doses limits (though does not eliminate) bronchoconstriction risk relative to propranolol. Supplied as two distinct salt forms: tartrate (twice-daily IR, 3-4 hour half-life) and succinate (once-daily prolonged-release via multiple-unit pellet system delivering near-zero-order release over 24 hours). 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 stocked
Tartrate IR film-coated tablets: 25mg (titration / elderly initiation), 50mg (NICE NG136 standard antihypertensive maintenance), 100mg (angina and post-MI secondary prevention). Succinate prolonged-release tablets: 25mg (HFrEF initiation per MERIT-HF protocol), 50mg (hypertension and heart failure up-titration), 100mg (maintenance hypertension and HFrEF), 200mg (MERIT-HF target dose and migraine prophylaxis). IV solution: 1mg/ml metoprolol tartrate in 5ml glass ampoules for acute coronary syndrome rate control and supraventricular tachyarrhythmia. All tablets supplied as scored or unscored film-coated per market specification, in HDPE bottles or destination-language blister packaging.
Indications scope
Essential hypertension as NICE NG136 step 4 (after ACE inhibitor or ARB plus CCB plus thiazide-like diuretic), favoured in younger patients with compelling cardiac comorbidity. Stable and unstable angina pectoris per NICE NG185 first-line. Heart failure with reduced ejection fraction (HFrEF, NYHA II to IV) per NICE NG106 — succinate salt only, 12.5mg initiation titrated to 200mg target over 8 to 12 weeks. Post-myocardial infarction secondary prevention per NICE NG185 (IV acute phase, oral chronic phase). Atrial fibrillation rate control per NICE NG196 first-line. Supraventricular and ventricular tachyarrhythmias. Migraine prophylaxis per NICE CG150 third-line. Symptomatic hyperthyroidism adrenergic control.
Buyer fit
UK NHS hospital trusts for IV ampoules (acute coronary syndrome protocols, AF rate control) and oral tartrate/succinate (post-MI clinics, heart failure services, atrial fibrillation clinics). NHS Drug Tariff Category M generic dispensing for community pharmacy. GCC cardiovascular tender desks: Saudi Arabia (NUPCO, SFDA), UAE (MoHAP, DHA), Kuwait (CMSPS), Qatar (Hamad Medical Corporation, MoPH), Oman (MoH), Bahrain (NHRA). African public-sector procurement: Nigeria (NAFDAC, FHC), Kenya (KEMSA, PPB), Ghana (FDA, GHS), South Africa (SAHPRA, NDoH), Ethiopia (EFDA, EPSS), Tanzania (MSD, TMDA). EU community-pharmacy and hospital tender chains via partner MIA(IMP) holders.
What we file with the quote
Indian manufacturer's CDSCO Form 26 export licence and EU-GMP / WHO-GMP certificate, Certificate of Pharmaceutical Product (CoPP) per WHO format 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, full CTD Module 1-5 dossier for new-market registration submission, bioequivalence study report versus the SAHPRA / SFDA / MHRA reference listed drug (Lopressor for tartrate, Toprol-XL or Betaloc-ZOK for succinate), and for IV ampoules a sterility certificate and bacterial endotoxin (LAL) results.
Lead times
Stock-line strengths (tartrate 50mg, 100mg; succinate 50mg, 100mg, 200mg) ship in 4 to 6 weeks from PO ex-Mumbai. 25mg titration strengths and IV ampoules typically 6 to 8 weeks due to lower campaign frequency. Tender quantities (>1M tablets per dose-strength) require dedicated campaign batch scheduling; lead time 8 to 10 weeks from PO. Sea freight transit adds 7 to 21 days depending on destination port. Air freight available for urgent NHS Specials or tender top-up orders. Cold-chain not required — ambient transport with desiccant for tropical Zone IVa/IVb destinations. On-time-in-full performance FY24-25 across the cardiovascular portfolio was 98.4%.
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. Metoprolol's NICE NG106 HFrEF first-line status and MERIT-HF mortality evidence base make the succinate XL salt volume-dominant in heart failure and post-MI lanes globally, while tartrate IR carries hypertension and AF rate control volume.
UK NHS hospital and community pharmacy
NHS Drug Tariff Category M generic dispensing for metoprolol tartrate 50mg and 100mg community-pharmacy lines. NHS Supply Chain framework agreements for hospital IV ampoules and prolonged-release succinate tablets across the heart failure service and post-MI cardiology rehabilitation network. M Care supplies UK WDA(H)-licensed wholesalers with QP audit pack on file, batch CoA in BP-aligned format, and Article 40 / EU-IMPD release pathway through partner UK MIA(IMP) holders for non-EEA imports post-Brexit. MHRA Specials route available for non-standard pack sizes or unlicensed-strength tartrate / succinate variants against hospital specials prescription.
GCC government tender supply
Gulf Health Council Central Registration route or state-by-state via SFDA (KSA), MoHAP/DHA (UAE), CMSPS (Kuwait), MoPH (Qatar), MoH (Oman), NHRA (Bahrain). M Care holds CTD M1 country-specific overlay packs and Arabic SmPC + PIL translations on file. NUPCO framework response timelines are 14 to 21 days from RFQ; we hold three Indian partner manufacturers with active SFDA registrations on tartrate 50mg / 100mg and succinate 50mg / 100mg to give NUPCO desks supply redundancy. SEHA cardiology service formulary and Hamad Medical Corporation heart failure clinic are recurring institutional buyers for the succinate XL salt.
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. Metoprolol features on every country's Essential Medicines List with both salt forms specified separately for hypertension (tartrate) and HFrEF (succinate). Global Fund cardiovascular comorbidity programmes (HIV-CVD overlap) include metoprolol on selected formularies. Sea-freight LCL/FCL via Mumbai / Nhava Sheva to Lagos / Mombasa / Durban / Dar es Salaam is the standard logistics lane; 6 to 8 week sea transit with FFP and pre-shipment QC sampling. Zone IVb stability data on file for tropical destinations.
EU and other regulated markets
EU member states via Article 40 importation licence held by partner MIA(IMP) and QP batch certification; 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. Metoprolol is registered in 100+ countries via Indian generic manufacturers; M Care's role is dossier and tender-pack assembly, not standalone manufacturing — partner manufacturers handle the API and finished-dosage. Bioequivalence study versus the destination-country reference listed drug (Lopressor for tartrate, Toprol-XL for succinate in US-aligned markets; Betaloc-ZOK in EU-aligned markets) is the recurring filing requirement.
Tartrate vs succinate salt is not interchangeable for HFrEF — the MERIT-HF mortality evidence applies to the succinate CR/XL salt only.
Adult hypertension starting dose tartrate 50mg BD or succinate XL 50mg OD; 25mg starting in elderly >75 years, hepatic-impaired adults, intravascular volume-depleted patients. Titration target depends on indication: hypertension typically 100mg/day tartrate or succinate after 3 to 4 weeks if BP response inadequate. HFrEF target dose is succinate 200mg OD per the MERIT-HF protocol — titrated 12.5mg → 25mg → 50mg → 100mg → 200mg at minimum 2-weekly intervals subject to tolerance and haemodynamic stability. The salts are not bioequivalent for HFrEF because the COMET trial (Lancet 2003) used tartrate not succinate and was therefore inappropriately powered for the mortality endpoint; current guidelines (NICE NG106, ESC HF) specify the succinate XL salt for heart failure indications. Conversion for non-HFrEF indications approximately 1:1 on total daily dose (e.g., tartrate 50mg BD ≈ succinate XL 100mg OD). Post-MI secondary prevention starts with IV metoprolol 5mg every 2 min up to 3 doses for haemodynamically stable STEMI within 24h, then oral conversion at tartrate 50mg BD or succinate 100mg OD per NICE NG185. Atrial fibrillation rate control at tartrate 25 to 100mg BD per NICE NG196, targeting resting ventricular rate below 110 bpm (lenient) or below 80 bpm (strict, post-AFFIRM and RACE II evidence). Contraindications: second or third degree AV block without pacing, severe bradycardia (HR <50), cardiogenic shock, decompensated heart failure, severe peripheral arterial disease, prinzmetal angina, untreated phaeochromocytoma without alpha-blockade. Bronchospasm precaution: cardioselective at therapeutic doses but loses selectivity at higher doses; avoid in asthma unless no alternative, monitor in COPD. Beta-blocker withdrawal syndrome — do not stop abruptly, taper over 1 to 2 weeks to avoid rebound tachycardia and ischaemia. Diabetes: masks symptoms of hypoglycaemia (palpitations, tremor) while preserving sweating — counsel patients on tactile and visual signs. Drug interactions: verapamil and diltiazem (additive AV block, avoid combination), digoxin (additive bradycardia, monitor), insulin and oral hypoglycaemics (masked hypoglycaemia symptoms), CYP2D6 inhibitors fluoxetine / paroxetine / bupropion / quinidine (raise metoprolol exposure 2-5 fold, dose reduction or alternative beta-blocker), clonidine (do not co-withdraw — stop beta-blocker first then clonidine). Pregnancy: limited human data; tartrate has been used in pregnancy hypertension when alternatives unsuitable; labetalol or methyldopa preferred per NICE NG133. Breastfeeding: small amounts in breast milk; generally compatible with monitoring. 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
Metoprolol is registered in 100+ countries via Indian generic manufacturers. The dossier work for any new market is typically CTD Module 1 country-specific assembly plus Module 3 reuse — Modules 2 to 5 do not change between destinations. Critically, tartrate and succinate file as separate marketing authorisations because they are different active substances under most regulators.
WHO Essential Medicines List
Both metoprolol tartrate and metoprolol succinate are on the WHO Model List of Essential Medicines (23rd edition, 2023) core list under the cardiovascular section. Tartrate covers hypertension, angina, AF rate control and post-MI secondary prevention; succinate covers HFrEF specifically because of the MERIT-HF evidence. WHO EML status is the gateway to Global Fund cardiovascular comorbidity tender eligibility and donor-funded procurement programmes. Metoprolol is not currently on the WHO Prequalification finished pharmaceutical product list because it is procured through stringent regulatory authority pathways rather than WHO PQ for most tenders.
MHRA (United Kingdom)
Metoprolol tartrate and metoprolol succinate hold UK marketing authorisations under multiple PL numbers covering 25mg, 50mg, 100mg tartrate IR and 25mg, 50mg, 100mg, 200mg succinate XL strengths plus 1mg/ml IV. NHS Drug Tariff Category M generic dispensing applies to community-pharmacy lines. NICE NG106 (chronic heart failure) names metoprolol succinate as a first-line beta-blocker for HFrEF; NICE NG136 (hypertension) positions beta-blockers as step 4; NICE NG185 (acute coronary syndromes) supports early metoprolol post-STEMI; NICE NG196 (atrial fibrillation) lists metoprolol as first-line rate control; NICE CG150 (headache) includes metoprolol succinate as third-line migraine prophylaxis. MHRA Specials route available for unlicensed strength or pack-size variants.
EMA (European Union) and EU member states
Decentralised Procedure and Mutual Recognition Procedure registrations across EU/EEA via national medicines agencies (BfArM Germany, AIFA Italy, AEMPS Spain, ANSM France, MEB Netherlands, INFARMED Portugal). Tartrate (Betaloc, Lopressor reference brands) and succinate (Beloc-ZOK, Selo-Zok reference brands) hold separate marketing authorisations. Article 40 importation licence via partner MIA(IMP) holder for non-EEA-manufactured supply with EU-zone QP batch release. Bioequivalence study versus the reference listed drug is mandatory for generic registration. ESC heart failure guidelines mirror NICE NG106 in specifying succinate XL for HFrEF based on MERIT-HF.
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 not in scope: SFDA (KSA), MoHAP / DHA / DoH Abu Dhabi (UAE), CMSPS / MoH DFC (Kuwait), MoPH / DPDC (Qatar), DGPA (Oman), NHRA (Bahrain). Metoprolol is on every state's essential medicines list with both salts specified. NUPCO framework responses for large hospital tenders; SEHA cardiology service formulary for Abu Dhabi public hospitals; Hamad Medical Corporation heart failure clinic for Qatar. Arabic SmPC and PIL translations on file.
African and LMIC markets
NAFDAC (Nigeria), PPB / KEMSA (Kenya), FDA Ghana, SAHPRA (South Africa), EFDA / EPSS (Ethiopia), TMDA / MSD (Tanzania), NDA (Uganda), NRA (Rwanda) registration pathways. Metoprolol features on every country's Essential Medicines List. SAHPRA reliance pathway for products with EU GMP, US FDA, MHRA, PIC/S, or WHO PQ inspection coverage compresses review from 24-36 months to 9-14 months. Zone IVb stability data mandatory for tropical destinations. Bioequivalence study versus the destination-country reference listed drug required for solid oral generic registration. Global Fund cardiovascular comorbidity programmes include metoprolol on selected formularies for HIV-CVD overlap populations.
Pharmacovigilance and adverse-event reporting
Metoprolol is post-marketing surveillance in every regulated market. UK Yellow Card scheme, EU EudraVigilance, SFDA NPC (KSA), NAFDAC PV unit (Nigeria) — all handled by the MAH or Indian manufacturer's local responsible person. Reporting timelines are 15 days for serious unexpected adverse reactions and 90 days for non-serious per ICH-E2D. Periodic Safety Update Reports (PSURs) on the standard ICH-E2C(R2) cycle. Major ADR signals: bradycardia, AV block, bronchospasm in susceptible patients, fatigue, cold extremities, masked hypoglycaemia in diabetes, beta-blocker withdrawal syndrome on abrupt discontinuation. Cardioselective at therapeutic doses means lower bronchospasm risk than propranolol but selectivity reduces at higher doses — monitor in asthma and COPD.
Metoprolol's tender-line and clinical companion molecules
Cardiovascular tenders are rarely single-line. Metoprolol pairs with ACE inhibitors, ARBs, calcium channel blockers, statins and antiplatelets across the NICE NG106 / NG136 / NG185 / NG196 step-ups. Internal links to the molecules and services already covered.
Amlodipine
Dihydropyridine CCB. NICE NG136 step 1A first-line for adults of any age with Black African or Caribbean origin, and step 2 partner with ACE/ARB for other adults. Tender-line companion across all hypertension procurement.
Losartan
First-in-class ARB. NICE NG136 step 1B first-line for adults under 55 not of Black African or Caribbean origin. ACE-intolerance switch path. Metoprolol step 4 sits on top of ARB + CCB + thiazide combination for resistant hypertension.
Clopidogrel
Thienopyridine P2Y12 inhibitor. NICE NG185 post-MI secondary prevention DAPT partner with aspirin. Metoprolol completes the post-MI triple package: beta-blocker plus DAPT plus statin.
Atorvastatin
HMG-CoA reductase inhibitor (statin). NICE NG181 primary and secondary prevention CV risk reduction. Metoprolol plus atorvastatin is the standard post-MI dual prevention pairing alongside DAPT.
GCC tender response service
SFDA, NUPCO and state-by-state tender desks for metoprolol alongside the broader cardiovascular pack. 14-21 day turnaround from RFQ to bid with three-manufacturer-redundancy quotes on both tartrate and succinate salts.
EU-GMP import workflow
Metoprolol into Germany, France, Italy, Spain and the Netherlands via partner MIA(IMP) holders with QP batch release. Article 40 importation licence and EU CTD overlay handled including separate filings for tartrate (Lopressor reference) and succinate (Beloc-ZOK reference).
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.
- Three-manufacturer-redundancy quote. M Care quotes three Indian partner manufacturers per salt-and-dose combination for tender-supply redundancy. 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. Quote validity is 30 days from issue.
- 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 within 5 to 10 working days from PO. 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 file as separate dossiers under most regulators because they are different active substances. Typical full-dossier preparation timeline is 30 to 45 working days; new-market regulatory review is 6 to 24 months depending on regulator backlog and reliance-pathway eligibility.
- Manufacturing campaign and freight. Stock-line strengths (tartrate 50mg, 100mg; succinate 50mg, 100mg, 200mg) ship from existing manufacturer inventory in 4 to 6 weeks from PO. 25mg titration strengths and IV ampoules typically 6 to 8 weeks due to lower campaign frequency. Tender quantities greater than 1M tablets per dose-strength require dedicated campaign batches with 8 to 10 week PO-to-shipment timeline. 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, Form 14, sterility certificate for IV ampoules).
- Ongoing supply and pharmacovigilance. Post-shipment: M Care provides monthly NHS Drug Tariff line confirmation for UK community-pharmacy buyers, SFDA / NUPCO monthly availability confirmations for GCC tender desks, and CSV / Excel tender-line trackers for African public-sector buyers. Pharmacovigilance Yellow Card / EudraVigilance / NPC reporting is the partner manufacturer's MAH responsibility; M Care coordinates the local responsible person paperwork. Quarterly CTD Module 3 update reviews to ensure dossier currency. Periodic Safety Update Reports (PSUR) on the ICH-E2C(R2) cycle for EU/UK markets. HFrEF cardiology service formulary monitoring for institutional buyers where the succinate XL salt sits on dedicated heart-failure clinic formularies.
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, manufactured using multiple-unit pellet system technology for 24-hour zero-order release. Metoprolol tartrate intravenous solution 1mg/ml in 5ml ampoules for hospital acute coronary syndrome protocols. 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 stocked. Tartrate is the short-acting salt (plasma half-life 3 to 4 hours) used for hypertension, angina and AF rate control, dosed twice or three times daily. Succinate is the prolonged-release salt engineered for once-daily dosing with steady plasma concentration. Critically, the MERIT-HF heart failure mortality data applies specifically to succinate XL/CR, not tartrate, so tender specifications for HFrEF indications must call out 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?
Metoprolol is off-patent in every major market and procured generically across our network. We ship into the United Kingdom (MHRA generic licence holders and Specials route), UAE (MoHAP 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 has documented pathway, dossier format (CTD or eCTD) and stability zone requirement (Zone IVa or IVb for tropical markets) which we match at the manufacturer-selection stage.
What is the lead time for metoprolol shipments and minimum order quantity?
Ex-works lead time from confirmed PO is 4 to 6 weeks for tablet finished product against existing stock, 8 to 10 weeks for fresh manufacturing batch. Add 7 to 21 days for sea freight depending on destination port. Air freight available for urgent NHS Specials or tender top-up orders. Minimum order quantity is typically 100,000 tablets per strength for finished pack, or 25kg API for bulk drug substance. On-time-in-full performance for FY24-25 across our cardiovascular portfolio was 98.4%.
Does M Care supply the IV metoprolol injection for acute coronary syndrome hospital protocols?
Yes. Metoprolol tartrate IV 1mg/ml in 5ml glass ampoules is part of our cardiology hospital range, supplied to NHS trusts via licensed importers and to GCC and African hospital tenders directly. Each ampoule batch ships with CoA, sterility certificate, bacterial endotoxin (LAL) results, and stability data per ICH Q1A(R2) Zone IVa or IVb as required. Cold-chain not needed (store below 25 degrees Celsius protected from light) but secondary packaging includes temperature-monitoring sticker for high-value hospital tenders.
How do you handle the tartrate-versus-succinate bioequivalence question in tender substitutions?
The salts are not interchangeable for heart failure dosing because succinate XL achieves the gradual plasma profile required by MERIT-HF target dose titration. For hypertension and angina the conversion is approximately 1:1 on total daily dose (e.g., tartrate 50mg BD equivalent to succinate XL 100mg OD). 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 or Betaloc-ZOK 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?
Yes. Our manufacturing partners maintain CTD and eCTD dossiers compliant with ICH M4, including Module 2.3 Quality Overall Summary, Module 3.2.S (drug substance) with DMF reference, Module 3.2.P (drug product) with full pharmaceutical development, manufacturing process, control of excipients, container closure system, stability data per ICH Q1A(R2) for the relevant climatic zone, and Module 3.2.R regional information. Bioequivalence study reports versus the reference listed drug (Lopressor or Toprol-XL) are available under CDA for tender submissions to MHRA, MOHAP, SFDA, NAFDAC, SAHPRA and EFDA.
Metoprolol tartrate IR + succinate XL + IV — three-manufacturer-redundancy supply for NICE NG106 HFrEF, post-MI secondary prevention and atrial fibrillation rate control across NHS, GCC and Africa.
Metoprolol is everyday cardiology — global, generic, high-volume across two distinct salt forms with different clinical positioning. M Care holds three Indian partner manufacturers per salt-and-strength combination for supply redundancy, with NHS Cat M, SFDA, NUPCO, NAFDAC, KEMSA, SAHPRA, TMDA and EU MIA(IMP) registrations all on file or readily assembled.