Oxaliplatin injection — Indian WHO-GMP supply for FOLFOX, FOLFIRINOX and XELOX colorectal, gastric and pancreatic regimens.

Two presentation families. Lyophilised powder for reconstitution in 50mg, 100mg, 150mg and 200mg vials — reconstituted in water for injection to 5 mg/mL, then further diluted in 5% dextrose to 250-500 mL for infusion. 5 mg/mL solution for infusion (pre-mixed) in 10mL (50mg), 20mL (100mg) and 40mL (200mg) presentations — diluted directly into 5% glucose for infusion. Standard FOLFOX dose 85 mg/m² IV over 2 hours every 14 days; XELOX 130 mg/m² over 2 hours every 21 days. 5% dextrose only as diluent — never 0.9% NaCl, Ringer's or Hartmann's. Chloride ion exchange degrades the platinum-DACH complex.

The DACH carrier ligand is responsible for a class-distinct sodium-channel modulation that produces cold-induced acute neuropathy in 90%+ of patients within hours of infusion — finger and toe dysaesthesia, perioral warmth, and pharyngo-laryngeal dysaesthesia (sensation of suffocation without airway obstruction) triggered by cold beverages, cold air, refrigerator-cold metal cutlery or cold-water hand contact. It is alarming for patients who haven't been counselled, and avoidable. The patient information leaflet sets the counselling note prominently: avoid cold drinks, cold food, cold air exposure and cold metallic surfaces for 5-7 days post-infusion. Warm beverages, scarves, gloves outdoors and pre-warming cutlery at home are the practical mitigations. The pharyngo-laryngeal sensation is self-limited; documented airway patency plus reassurance is the standard management.

Cumulative chronic peripheral neuropathy (CIPN) is oxaliplatin's long-term dose-limiting toxicity. The cardinal threshold is 540 mg/m² cumulative dose — at FOLFOX 85 mg/m² that's six full cycles, at XELOX 130 mg/m² roughly four cycles. Beyond 540 mg/m², CIPN incidence rises sharply (50%+ at 780 mg/m², 70%+ at 1170 mg/m²) and functional impairment of hands and feet becomes long-lasting. The DEB-C protocol (Diagnose, Educate, Block, Continue/dose-modify) is standard: dose reduced 25% on grade 2 functional CIPN, oxaliplatin held on grade 3-4. Stop-and-go strategies — OPTIMOX1/2 protocols and FOLFOX-7/FOLFIRINOX-light schedules — interrupt oxaliplatin while continuing the fluoropyrimidine, reintroducing on disease progression. SmPC and prescribing-information artwork carry the cumulative-threshold note.

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 — KFSHRC Riyadh, NCCCR Hamad Doha and SEHA cancer centres are the main tertiary-care 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. Africa CDC and WHO-AFRO cancer-control programme procurement is a high-volume channel. 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 US FDA or Australian TGA registrations on oxaliplatin. 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 oxaliplatin diaquo, dimer, transplatin diastereoisomer and free oxalate, platinum content by ICP-MS, optical rotation for (1R,2R) DACH configuration, water content by Karl Fischer, pH, sterility, bacterial endotoxin, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate with cytotoxic-suite endorsement, manufacturing licence, WHO Prequalification assessment-status documentation where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with cytotoxic hazard pictogram + cold-induced neuropathy patient-counselling note + 5% dextrose-only diluent warning + chloride-incompatibility warning + cumulative-dose threshold note, plus temperature logs from pre-dispatch through on-arrival (continuous 2-8°C logging on the solution form, ambient logging on the lyophilised form). 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. Cytotoxic drug-product manufacturing facility documentation includes dedicated cytotoxic-suite isolation, environmental monitoring and cross-contamination controls per EU GMP Annex 1 and PIC/S guidance — these are scrutinised closely on platinum cytotoxic registrations. Lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. WHO PQ assessment dossier prepared separately for Global Fund and Africa CDC qualification. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 7-14 working days from confirmed order. For tender awards (Global Fund, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS oncology pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours for lyophilised stock. Made-to-order batches run 8-12 weeks inclusive of QC release (with ICP-MS platinum content and chiral verification on every batch) and destination artwork. Lyophilised oxaliplatin vials do NOT require cold-chain in transit — they ship at 15-25°C ambient, protected from light. Pre-mixed 5 mg/mL solution for infusion DOES require 2-8°C cold-chain transit with continuous data-logging through to final destination; pre-validated insulated shippers with phase-change material plus on-arrival DataLogger reading. Both presentations protected from light throughout. Transit temperature is logged on every consignment for QA traceability.