Cisplatin injection — Indian WHO-GMP supply, with MHRA shortage cover on the UK side.

Cisplatin is supplied as 10mg/10ml, 25mg/25ml, 50mg/50ml and 100mg/100ml vials — aqueous solution for infusion at 1mg/ml, stabilised in 0.9% sodium chloride. Pack size is typically one vial per carton in hospital pack; multi-vial consolidations are available against firm orders. The 50mg and 100mg strengths are the highest-volume lines for adult oncology; the 10mg and 25mg are used for paediatric protocols and for fine dose titration in renally-impaired patients.

Yes. Cisplatin has sat on the MHRA (Medicines and Healthcare products Regulatory Agency, UK) shortage register intermittently since the mid-2020s, and UK NHS hospital pharmacies routinely use the named-patient import and MHRA Specials routes when the primary licensed supplier cannot fill. M Care prepares the Special-form manufacturer-side documentation pack (WHO-GMP certificate, batch CoA, MoA, CoPP, pack insert in English) so the importing UK pharmacy's Responsible Person can complete the import notification without chasing paperwork across time zones. Air-freight from Mumbai to a UK bonded warehouse runs 3-5 days once the Special form is signed.

Cisplatin requires chloride-stabilised diluent: 0.9% sodium chloride is mandatory. Do not use 5% glucose alone — it will cause aquation of the platinum complex and loss of potency, which is the opposite of the rule for carboplatin. Some protocols use a mixed 0.45% NaCl / 5% glucose diluent with adequate chloride, but pure 5% glucose is not acceptable. On aluminium, the answer is the same as carboplatin and oxaliplatin: aluminium-free administration sets, needles and spikes. Aluminium reacts with the platinum complex, forms a black precipitate and loses potency — hospital trusts should use only PVC or polyolefin sets with non-aluminium spikes.

The UK (named-patient / MHRA Specials during shortage, or routine supply to specialist importers), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda) for tender and teaching-hospital supply, Egypt, Jordan, Iraq on the Levant side, and Germany under §72 AMG. Also the Philippines for the SEA side. We do not supply into India. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis, Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert, and temperature logs from pre-dispatch through on-arrival. For UK named-patient orders, the MHRA Special-form manufacturer-side annex is prepared separately. A pharmacovigilance contact is nominated in the destination market on registration, with PSUR to ICH E2C.

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, BfArM and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Cisplatin is off-patent in all relevant markets and has a well-established CMC template — lead time on a dossier against a new registration is typically 3-5 weeks from NDA signature. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For UK named-patient shortage cover with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours once the Special form is signed. Made-to-order batches run 6-10 weeks inclusive of QC release and destination artwork. Cisplatin does not require cold-chain — it ships at 15-25°C protected from light, and refrigeration actually causes precipitation. Transit temperature is still logged on every consignment, with the excursion protocol covering both the hot tail and the cold tail.