Bisoprolol tablet supplier (bisoprolol fumarate, 1.25 / 2.5 / 5 / 10mg)

Bisoprolol fumarate film-coated tablets in 1.25mg, 2.5mg, 5mg and 10mg. The 3.75mg and 7.5mg strengths used in some EU markets are available against confirmed PO volume. Standard private-wholesale packs are blisters of 28 or 30. Hospital and tender packs are 100s, 500s or 1000s in HDPE bottles or aluminium-aluminium blisters, depending on the destination market and the partner-site approved artwork. Country-specific carton variations (Arabic and English for the GCC, Spanish or Portuguese for LATAM) are handled in artwork at the dossier-filing stage.

Bisoprolol, metoprolol succinate, carvedilol and nebivolol are the four beta-blockers NICE NG106 names as first-line for HFrEF. Bisoprolol has two practical advantages for tender pharmacy: a clean once-daily oral regimen at 10 to 12 hour half-life (no extended-release reformulation), and dual hepatic/renal elimination which makes dose-finding more forgiving than predominantly single-route agents. The CIBIS-II evidence base (34 percent relative mortality reduction, Lancet 1999) is what most tender specifications cite. Metoprolol is supplied separately on our cardiovascular range for buyers with a metoprolol-anchored protocol.

Yes. Bisoprolol is on the 23rd WHO Model List of Essential Medicines (2023), core list, cardiovascular section, as an oral beta-blocker for heart failure and ischaemic heart disease. EML status is what most African national essential-medicines lists and Global Fund or donor procurement schedules anchor on, so the WHO EML reference is normally enough to support inclusion.

Bisoprolol is not on the WHO PQ finished pharmaceutical product list as a routine matter. WHO PQ historically focused on HIV, TB, malaria, reproductive health and a few cardiovascular molecules. For bisoprolol, procurement runs through SRA-equivalent registration pathways: MHRA, EMA national authorisations, GCC central registration and African medicines authorities. We file against those rather than against the WHO PQ programme.

The pivotal trial is CIBIS-II (Cardiac Insufficiency Bisoprolol Study II, Lancet 1999), which randomised 2,647 patients with NYHA class III to IV HFrEF on background ACE inhibitor and diuretic to bisoprolol or placebo, titrated to a target of 10mg once daily. The trial was stopped early for a 34 percent relative reduction in all-cause mortality, with parallel reductions in sudden death and worsening-HF hospitalisation. CIBIS-III subsequently tested the sequencing question against enalapril-first initiation and found no advantage for either order. NICE NG106 cites this evidence base and names bisoprolol as one of four first-line HFrEF beta-blockers.

Yes. We run dossier filing through the partner-site RA team, in CTD or eCTD format depending on the authority. Typical first-time filings include NAFDAC (Nigeria), PPB (Kenya), TMDA (Tanzania), SAHPRA (South Africa), MCAZ (Zimbabwe), FDA Ghana, ANVISA (Brazil), INVIMA (Colombia), DRAP (Pakistan) and the Drug Administration of Vietnam. The bisoprolol file moves quickly relative to newer molecules because of the long real-world safety record and the WHO EML reference. Authority queries are handled by the partner-site QA/RA function, with M Care coordinating the local agent and apostilled supporting documents.

For an already-registered market, repeat orders move from PO confirmation to FCA dispatch in 4 to 6 weeks. For first-time market entry, the schedule depends on the authority's published review timeline. Indicative ranges are 8 to 14 weeks from artwork sign-off to dispatch for markets with a fast SRA-recognition pathway, longer where local clinical or bioequivalence data are required. We share a milestone plan at the documentation-pack stage so procurement and regulatory affairs can align stocking with the authority's response window.