Pemetrexed injection — Indian WHO-GMP supply for non-squamous NSCLC and mesothelioma.

100mg and 500mg lyophilised vials. 500mg is the high-volume oncology-tender line — adult dosing 500 mg/m² yields a 1.5g dose for an average BSA, drawn from three to four 500mg vials per cycle. 100mg supports paediatric oncology protocols where BSA is small, body-surface fine-tuning, and remainder dose handling. Reconstitute with 20 mL preservative-free 0.9% NaCl per 500mg vial (4 mL per 100mg vial), swirl until dissolved, dilute further into 100 mL of 0.9% NaCl or 5% dextrose for IV infusion over 10 minutes. NOT compatible with calcium-containing diluents like Lactated Ringer's (per current EMA SmPC). Pemetrexed is neither a vesicant nor an irritant — standard peripheral IV is acceptable.

The Niyikiza/Hanauske data on supplementation-driven myelosuppression reduction are decisive — without folate and B12 supplementation, grade 3-4 myelosuppression rates approach 40%; with supplementation, rates fall to single digits. EMA, MHRA and FDA labelling all mandate explicit supplementation instructions on the pemetrexed SmPC. Our destination-language pack inserts and SmPCs carry the protocol prominently: folic acid 350-1000 mcg PO daily started at least 7 days before the first dose, continued throughout treatment and for 21 days after the last dose; AND vitamin B12 1000 mcg IM every 9 weeks, first injection in the week before the first pemetrexed dose. Dexamethasone 4 mg PO BD for 3 days starting the day before infusion for skin-rash prophylaxis is also documented. The dispensing-side responsibility (counselling, prescription of folate and B12) sits with the prescribing oncology pharmacy; the manufacturer-side responsibility (clear SmPC labelling) is ours.

Pemetrexed is histology-selective. The Scagliotti JCO 2008 phase III subgroup analysis (cisplatin + pemetrexed vs cisplatin + gemcitabine, first-line NSCLC) showed pemetrexed superior in adenocarcinoma and large-cell histologies but inferior to gemcitabine in squamous-cell NSCLC — the underlying mechanism is higher thymidylate synthase expression in squamous tumours, which titrates out pemetrexed's TS inhibition. EMA, MHRA and FDA labelling all restrict pemetrexed to non-squamous NSCLC. Our destination-language SmPC carries the histology-gate restriction prominently. Molecular tumour board confirmation of non-squamous adenocarcinoma or mesothelioma histology is the prescribing-side responsibility before first dose; clear indication restriction in the labelling is ours.

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 — oncology tenders to NUPCO, MoHAP, Hamad Medical Corporation NCCCR, and similar — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital oncology supply with SRA-reliance pathway support via MHRA / EMA recognition — Africa CDC Cancer Care Initiative grants are a relevant 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 FDA or TGA registrations. 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 current Ph.Eur./USP monograph, water content by Karl Fischer for the heptahydrate, pH on reconstitution, sterility, bacterial endotoxin, particulate matter, residual solvents per ICH Q3C), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate with dedicated oncology-suite cross-contamination control evidence, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with mandatory folate-B12 supplementation protocol, non-squamous histology indication restriction, renal contraindication labelling (CrCl <45 mL/min), NSAID-interaction hold protocol, and cytotoxic-handling warnings, plus temperature logs from pre-dispatch through on-arrival. Cytotoxic-occupational-exposure compliance documentation included for hospital-pharmacy committee approval. 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. Pemetrexed CMC is well-established (Alimta off-patent since 2017 in most markets) — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. SRA-reliance dossier via MHRA or EMA recognition is the standard pathway for African and emerging-market registration; pemetrexed is not on WHO Prequalification (oncology cytotoxics are generally outside WHO PQ scope). Cytotoxic-handling and dedicated-suite cross-contamination control documentation prepared as a CTD addendum. M Care does not hold FDA or TGA registrations. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Africa CDC Cancer Care Initiative, 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. Made-to-order batches run 8-12 weeks inclusive of QC release, dedicated-oncology-suite cross-contamination test certificates, and destination artwork. Pemetrexed lyophilised vial does not require cold-chain in transit — it ships at 15-25°C ambient, protected from light. Cold-chain only kicks in at the hospital end after reconstitution if the infusion is held: reconstituted and diluted pemetrexed is stable for 24 hours at room temperature or 24 hours at 2-8°C per current EMA SmPC. Transit temperature is logged on every consignment for QA traceability.