Pemetrexed injection — supplier from India to UK, GCC and African cancer centres.
An antifolate antimetabolite for non-squamous NSCLC and malignant pleural mesothelioma. 100mg, 500mg and 1g lyophilised vials from Indian WHO-GMP partner lines, with the CTD dossier, premedication guidance and batch documentation a hospital oncology pharmacist expects on file.
Multiple WHO-GMP partner lines · 100mg, 500mg and 1g lyophilised vials · full CTD dossier on file.
Active ingredient
Pemetrexed disodium (pemetrexed disodium heptahydrate / 2.5-hydrate on label, depending on the manufacturing line). Antifolate antimetabolite cytotoxic. Mechanism: multi-target inhibition of thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyltransferase — disrupting pyrimidine and purine synthesis in dividing cells.
Strengths stocked
100mg, 500mg and 1000mg (1g) lyophilised vials. Powder for concentrate for solution for infusion. Reconstitute the 100mg vial with 4.2ml, or the 500mg vial with 20ml, of 0.9% sodium chloride preservative-free — final concentrate 25mg/ml, then diluted in 100ml 0.9% NaCl for a 10-minute intravenous infusion.
Indications
First-line metastatic non-squamous NSCLC with cisplatin; maintenance NSCLC after platinum-based first line; NSCLC monotherapy after prior chemotherapy; malignant pleural mesothelioma with cisplatin. Used in cisplatin-pemetrexed doublets and, after induction, as continuation or switch maintenance. We supply the pemetrexed component only — cisplatin is available separately from the M Care oncology roster.
Storage
Store the lyophilised vial at 25°C or below, protected from light. Do not freeze. Reconstituted and diluted solution is physically and chemically stable for 24 hours refrigerated (2-8°C). Ship at controlled ambient with validated thermal shippers; cold-chain lane available where the destination regulator specifies it.
Shelf life
24 months from manufacture for the lyophilised vial. Minimum 18 months residual shelf life at dispatch, or the consignment does not leave Mumbai. Longer residuals negotiable against firm tender awards.
Pack format
Single-vial carton, hospital pack. Amber Type-I glass vial with bromobutyl stopper and aluminium seal with flip-off cap. Outer carton carries destination-language patient information leaflet; regulator-style labelling applied before dispatch.
Hospital pharmacies, importers and tender desks across twenty markets.
India is our origin. We do not sell into the Indian market. Pemetrexed is exported only.
United Kingdom
NHS cancer-centre pharmacies and specialist unlicensed-medicines importers under the MHRA (Medicines and Healthcare products Regulatory Agency) Specials and named-patient import route. Where pemetrexed is sought as an unlicensed import for an individual patient or short-supply situation, the Mumbai desk prepares the MHRA Special documentation pack on the manufacturer side.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards and hospital-pharmacy purchase orders. CTD dossiers prepared for SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and GCC central registration. Apostilled CoPP and WHO-GMP certificate included in the registration pack.
Nigeria, Kenya, Ghana, South Africa
Public-sector oncology tenders and teaching-hospital supply through NAFDAC (Nigeria), PPB (Pharmacy and Poisons Board, Kenya), Ghana FDA and SAHPRA (South African Health Products Regulatory Authority). WHO-PQ (WHO Prequalification) pathway supported where tender terms specify it. NGO and Global Fund oncology buyers are catered for separately.
Germany
Supply via licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD Module 3 and Module 2 quality overall summary prepared for BfArM (German federal institute for drugs) recognition. Apostilled CoPP, CDSCO (Central Drugs Standard Control Organization, India) manufacturing licence, and chamber-attested Certificate of Origin included.
Premedication is not optional — it's the whole point.
Pemetrexed lives and dies by its supportive-care regimen. Every patient needs folic acid 350-1000 mcg orally once daily, starting at least seven days before cycle 1 and continuing for 21 days after the final dose, plus vitamin B12 1000 mcg intramuscularly every nine weeks, starting at least a week before cycle 1 — without it, haematological and GI toxicity climb sharply. Add dexamethasone 4mg PO twice daily the day before, day of and day after infusion to damp the cutaneous reaction. Dose is 500 mg/m² body surface area, day 1 of a 21-day cycle, infused over ten minutes in 100ml of 0.9% NaCl at 25mg/ml after reconstitution with preservative-free saline. Contraindicated where creatinine clearance is <45 ml/min — pemetrexed is renally cleared. Avoid or stagger NSAIDs around the dose in any degree of renal impairment. Third-space fluid (pleural effusion, ascites) delays clearance; drain before dosing where clinically feasible.
The documentation pack a regulator actually asks for.
Our role is manufacturer-facing. We sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary and non-clinical overview included; Module 1 administrative sections prepared in destination format.
CoA and MoA, per batch
HPLC assay, related substances, water content, residual solvents, reconstitution time, sterility and bacterial endotoxin — each signed by the manufacturer's authorised QC head. Per batch, not per consignment.
CoPP, WHO-GMP, MFG licence
Certificate of Pharmaceutical Product and WHO-GMP certificate issued by CDSCO (Central Drugs Standard Control Organization, India), apostilled where the destination requires it. Notarised copies travel in the shipping pack.
Pack insert, labels, artwork
Destination-language patient information leaflet, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). Artwork QC before print, not after.
Temperature control
Pre-shipment thermal validation on each shipper configuration, continuous in-transit logging, on-arrival inspection with a signed record. Excursion protocol defined before dispatch; out-of-spec deviations trigger a QP hold, not a quiet release.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C; signal-detection outputs shared with the marketing-authorisation holder.
Complete the oncology regimen.
Pemetrexed is usually one arm of a doublet or a maintenance line after platinum-based induction. We carry the full oncology cluster.
Paclitaxel
Taxane cytotoxic, breast and ovarian cancers. 30mg / 100mg / 260mg concentrate.
Docetaxel
Taxane cytotoxic, breast and NSCLC. 20mg / 80mg / 120mg concentrate.
Gemcitabine
Nucleoside antimetabolite, NSCLC and pancreatic. 200mg / 1g / 2g vials.
Oxaliplatin
Platinum cytotoxic, colorectal (FOLFOX). 50mg / 100mg / 200mg vials.
Bortezomib
Proteasome inhibitor, multiple myeloma. 2mg and 3.5mg lyophilised vials.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (100mg, 500mg or 1g), total vial volume, destination market, whether it is tender, hospital pharmacy or wholesaler, and the target delivery window.
- We route to the right line. Multiple Indian WHO-GMP partner lines on the M Care roster carry pemetrexed. Registered-market preference goes to facilities with in-country dossier status; cost-sensitive tender work goes to lines with the right price point.
- Commercial and regulatory offer. FOB / CIF price, lead time, a dossier-status note per destination, and the documentation pack you can expect with the shipment. Inside one working day for live enquiries.
- Order, produce, release, ship. QC release on the Indian side with pemetrexed-specific methods. Temperature-controlled dispatch, real-time in-transit logging, arrival inspection. Photo evidence of seal integrity and flip-off cap on request.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; premedication and reconstitution reference material shared with the receiving pharmacy on request.
Pemetrexed supply — the specific questions.
What strengths of pemetrexed do you supply?
Pemetrexed is supplied as 100mg, 500mg and 1000mg (1g) lyophilised vials — powder for concentrate for solution for infusion. The 100mg vial reconstitutes with 4.2ml of 0.9% sodium chloride preservative-free, the 500mg with 20ml, each to a 25mg/ml concentrate that is then diluted in 100ml of 0.9% NaCl for a 10-minute infusion. Single-vial hospital cartons; multi-vial pack configurations available against firm orders.
Which markets can you ship pemetrexed into?
We routinely ship into the UK (named-patient / MHRA Specials where required), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — tender and hospital supply), and Germany (§72 AMG import channels). We do not supply into India. Full market list under markets.
What premedication and supportive care does pemetrexed require?
Three things are mandatory, not optional. Folic acid 350-1000 mcg orally once daily, starting at least seven days before cycle 1 and continuing for 21 days after the last dose. Vitamin B12 1000 mcg intramuscularly every nine weeks, with the first dose at least a week before cycle 1. Dexamethasone 4mg orally twice daily the day before, day of and day after each pemetrexed infusion. Skip any of those and haematological, GI or cutaneous toxicity will climb. We share the full reference regimen with the receiving pharmacy on delivery.
What documentation is included with a pemetrexed consignment?
Every consignment ships with a batch-specific Certificate of Analysis and Method of Analysis, Certificate of Pharmaceutical Product where required, WHO-GMP certificate, CDSCO-issued manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert, and temperature logs where applicable. Apostille is added where the destination regulator requires it. A pharmacovigilance contact is nominated in the destination market against registration.
Do you provide CTD dossiers for pemetrexed registration?
Yes. Full CTD Module 3 dossiers are available against non-disclosure, for registration with MHRA, GCC central registration, national MoH authorities, SAHPRA, BfArM and comparable bodies. Module 2 quality overall summary and non-clinical overview are included, and Module 1 administrative sections are prepared in destination-specific format. See dossier preparation.
What are typical lead times for pemetrexed orders?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. Made-to-order batches run 6-10 weeks inclusive of QC release, reconstitution-time testing and destination-specific artwork. Air-freight transit to the UK or GCC runs 3-5 days; sea-freight to Africa, 18-28 days. Pemetrexed is stable at 25°C or below, so a standard ambient-controlled thermal shipper covers most lanes.
Is pemetrexed available as a generic from India?
Yes. Pemetrexed is off-patent across relevant markets and is manufactured at scale by multiple Indian WHO-GMP facilities. M Care works with multiple WHO-GMP partner lines on its oncology roster — substitute brand names are available against tender or hospital-formulary requirements. We supply the lyophilised vial presentation; the pre-mixed liquid formulation exists in some markets but is not part of the current M Care roster.
Send the specifics. You'll have a price inside one working day.
Strength, volume, destination, tender or hospital pharmacy, target delivery. That's the enquiry. Everything else — dossier, premedication reference, cold-chain paperwork — is on us.