Bortezomib injection — Indian WHO-GMP supply for multiple myeloma, mantle cell lymphoma and AL amyloidosis.

2mg and 3.5mg lyophilised vials. Reconstitute sub-cutaneous with 0.9% NaCl to a concentration of 2.5 mg/ml; reconstitute IV with 0.9% NaCl to 1 mg/ml. 3.5mg is the high-volume tender line for full-dose adult VRd, VTd and VCd induction at 1.3 mg/m². 2mg covers paediatric protocols and dose-reduced adult schedules (1.0 mg/m² SubQ for grade 2 peripheral neuropathy, 0.7 mg/m² for grade 3 with weekly schedule). Sub-cutaneous administration is the standard of care — peripheral neuropathy of any grade ~6% on SubQ versus ~16% on IV per APEX trial extension data, with non-inferior efficacy.

Multiple Indian generics are under WHO Prequalification assessment for Global Fund oncology programmes and Africa CDC cancer-control qualification. Confirm current PQ status on enquiry — the WHO PQ certificate is included in the shipping documentation pack where applicable. We engage on Global Fund pooled tenders, country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda, SAHPRA), and NGO procurement (MSF, Direct Relief, Partners In Health) through the same manufacturing lines. Indian generic bortezomib has a structural cost advantage versus originator and EU-sourced biosimilars — a meaningful access lever for African public-sector oncology programmes.

The prospective head-to-head SubQ-versus-IV trial and APEX trial extension data established that sub-cutaneous administration produces peripheral neuropathy of any grade ~6% versus ~16% on IV, with grade ≥3 neuropathy 6% versus 16%, while preserving non-inferior efficacy in newly diagnosed and relapsed/refractory multiple myeloma. SubQ is now the standard of care across NCCN, ESMO and UK NHS Macmillan guidelines. Reconstitute SubQ with 0.9% NaCl to 2.5 mg/ml (vs 1 mg/ml for IV); rotate injection sites between thighs and abdomen, avoiding bruised, sclerotic, erythematous or tender areas. Local injection-site reactions (mild erythema, induration) occur in ~5% of patients and resolve spontaneously.

Bortezomib peripheral neuropathy is the most common dose-limiting toxicity and the central reason for the global SubQ shift. Our destination-language pack inserts and SmPCs carry the standard NCCN / ESMO grading and dose-modification table: Grade 1 (paraesthesia without pain) — continue at full 1.3 mg/m². Grade 2 (paraesthesia with pain or interfering with function) — hold until resolution to ≤G1, restart at 1.0 mg/m². Grade 3 (interfering with activities of daily living) — hold until ≤G1, restart at 0.7 mg/m² and consider switch to weekly schedule. Grade 4 (disabling sensory loss or motor) — discontinue permanently. Aciclovir / valaciclovir prophylaxis instruction (varicella zoster reactivation 13-22% without prophylaxis) is documented alongside on the SmPC.

The UK (NHS oncology pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — haematology and ASCT-centre tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ assessment pathway support. Egypt, Jordan, Iraq on the Levant side. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). M Care does not hold FDA or TGA registrations for this molecule — confirm regulatory route on enquiry. We do not supply into India. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances per Ph.Eur./USP including boronic acid degradation product, water content by Karl Fischer of the lyophilised cake, pH on reconstitution, sterility, bacterial endotoxin, particulate matter, reconstitution clarity), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification assessment documentation where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with sub-cutaneous-administration instruction + peripheral-neuropathy dose-modification table + varicella zoster prophylaxis note + tumour-lysis-syndrome risk warning + cytotoxic-handling warning, plus temperature logs from pre-dispatch through on-arrival. PV contact nominated on registration.

Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Bortezomib requires CMC-specific attention to the boronate-ester stability and lyophilisation cycle validation — lead time on a dossier against a new registration is typically 5-8 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund oncology and Africa CDC cancer-control qualification. Cytotoxic-handling validation prepared as a CTD addendum. See dossier preparation.