Carboplatin injection — supplier from India to the UK, GCC and Africa.
A platinum-based cytotoxic on the WHO Essential Medicines List — first-line for advanced ovarian cancer, SCLC and NSCLC regimens. 50mg, 150mg, 450mg and 600mg aqueous vials from Indian WHO-GMP facilities, with the CTD dossier, AUC-dose guidance and batch documentation a regulated-market buyer expects.
WHO EML platinum cytotoxic · 50mg, 150mg, 450mg, 600mg aqueous vials · full CTD dossier on file.
Active ingredient
Carboplatin, a second-generation platinum-containing cytotoxic. Mechanism: forms DNA inter- and intra-strand crosslinks at the N7 position of guanine, blocking replication and transcription. Lower reactivity than cisplatin means a cleaner renal and neurological safety profile.
Strengths stocked
50mg/5ml, 150mg/15ml, 450mg/45ml and 600mg/60ml vials — 10mg/ml aqueous solution for infusion. The 450mg and 600mg bulk vials cover AUC-6 dosing for average-BSA patients without multi-vial pooling.
Indications
First-line advanced ovarian cancer (monotherapy or paclitaxel/carboplatin); platinum-sensitive recurrence; SCLC with etoposide; NSCLC with paclitaxel; head and neck SCC. Standard component of most gynae-onc and thoracic regimens under WHO EML listing.
Storage
Below 25°C, protected from light. Do not refrigerate — cold storage precipitates the platinum out of aqueous solution. Ambient-chain validated transit to destination with temperature logs issued on arrival.
Shelf life
24 months from manufacture; minimum 18 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Type I amber-glass vial, chlorobutyl rubber stopper, aluminium flip-off seal. Outer carton and leaflet in destination language.
Hospital pharmacies, importers and tender desks across twenty markets.
India is our origin. We do not sell into the Indian market. Carboplatin is exported only.
United Kingdom
NHS trust pharmacies and specialist importers under the MHRA Specials / named-patient route, plus NHS framework supply where a carboplatin line holds UK registration. We prepare the MHRA Special form pack on the manufacturer side where an unlicensed import is needed.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards and hospital pharmacy orders. Carboplatin sits on almost every GCC onco-formulary — CTD dossiers prepared for SFDA, MOHAP and GCC central registration. WHO-PQ variants routed where the tender calls for PQ status.
Nigeria, Kenya, Ghana, South Africa
Public-sector tenders (NAFDAC-registered supply into FGN, KEMSA, CMS, SAHPRA-approved provincial procurement) and teaching-hospital orders. WHO-PQ pathway for Global Fund and CHAI-backed tenders. NGO and MSF procurement handled separately on framework.
Germany
Supply via licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM recognition; EU-GMP capable partner sites preferred for European-market orders.
What an oncology pharmacist actually wants on the carboplatin line.
Dose carboplatin by Calvert formula — target AUC × (GFR + 25). Use a measured GFR (EDTA clearance) where available; Cockcroft-Gault over-estimates at normal serum creatinine and will push the dose high. Dilute in 5% glucose, not saline — chloride in 0.9% NaCl displaces platinum from the diplatinum ring and reduces efficacy. Avoid all aluminium-containing administration equipment (needles, spikes, IV sets); aluminium reacts with platinum to form a black precipitate and cut potency. Thrombocytopenia is the dose-limiting toxicity, nadir day 14-21 — platelet count before each cycle, not just baseline. Peripheral neuropathy is markedly lower than cisplatin, which is why carboplatin is the preferred platinum for elderly, frail and renally-impaired patients in gynae-onc and NSCLC regimens. Standard hydration is not required. Hypersensitivity risk climbs with cumulative exposure beyond 6 cycles — premedicate with corticosteroid and antihistamine on retreatment.
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. Carboplatin is WHO EML-listed, so WHO-PQ variants are on the roster for public-sector tender routes.
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 included.
CoA and MoA, per batch
HPLC assay, platinum content by ICP-OES, related substances, pH, sterility, endotoxin — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies included in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, 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 the ambient-controlled shipper, continuous logging in transit, on-arrival inspection with a signed record. Excursion protocol defined before dispatch — carboplatin must not freeze or fall below 2°C.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C.
Complete the carboplatin regimen.
Carboplatin rarely goes in alone. The TC (paclitaxel/carboplatin), carbo-etoposide and platinum-doublet protocols all combine with other cytotoxics on our oncology roster.
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 mix (50mg / 150mg / 450mg / 600mg), 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 WHO-GMP partner lines on the M Care roster carry carboplatin. Registered-market orders go to facilities with in-country or WHO-PQ 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, WHO-PQ or EU-GMP preference where relevant, and the documentation pack you'll see with the shipment. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side, including ICP-OES platinum content. Ambient-controlled dispatch, in-transit temperature logging, arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal logs archived for the full 24-month shelf life of the consignment. Pharmacovigilance contact opened on registration, PSURs compiled to ICH E2C.
Carboplatin supply — the specific questions.
What strengths of carboplatin do you supply?
Carboplatin is supplied as 50mg/5ml, 150mg/15ml, 450mg/45ml and 600mg/60ml vials — a 10mg/ml aqueous solution for infusion. The 450mg and 600mg bulk vials cover AUC-6 dosing for average-BSA patients in a single vial, which matters for tender economics and preparation-time budgets on a busy oncology day-unit. Pack size is typically 1 vial per carton; multi-vial hospital packs are available against firm orders.
Is carboplatin on the WHO Essential Medicines List, and does that affect tender eligibility?
Yes. Carboplatin is on the WHO Essential Medicines List core cytotoxic section, which means it sits on almost every national onco-formulary globally and is a standing line-item in public-sector oncology tenders. For Global Fund, CHAI, UNICEF, MSF and ministry-of-health tenders that specify WHO-PQ sourcing, we route carboplatin through WHO-prequalified variants on the M Care roster. For regulated-market buyers (NHS framework, SFDA, MOHAP, BfArM), we route through CTD-registered lines with local MoH approval. Either pathway is supported — the registration status is specified against destination on the quote.
Which markets can you ship carboplatin into?
We ship into the UK (NHS framework, named-patient and MHRA specials routes), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — public-sector tender and hospital supply with WHO-PQ pathway where specified), and Germany (§72 AMG import channels). We do not supply into India — M Care is an exporter of record only.
Why does carboplatin need to be diluted in 5% glucose rather than saline?
Chloride ions in 0.9% sodium chloride displace the cyclobutanedicarboxylate leaving group from the platinum centre, producing the same reactive aquated species as cisplatin and reducing carboplatin's pharmacological advantage. Standard admixture guidance across MHRA and EMA SmPCs is 5% glucose as the diluent. Our PILs and pharmacist-facing inserts mirror the SmPC wording; hospital pharmacy protocols in NHS trusts, GCC tertiary centres and African teaching hospitals reflect the same rule. It's a detail that matters because it's the most common compounding error on the molecule.
What documentation is included with a carboplatin consignment?
Every consignment ships with a batch-specific Certificate of Analysis (including ICP-OES platinum content), Method of Analysis, Certificate of Pharmaceutical Product where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with the Calvert-formula AUC-dose reminder, and ambient temperature logs. WHO-PQ certificates are included where the consignment is routed through a prequalified line. A pharmacovigilance contact is nominated in the destination market on registration.
Do you provide CTD dossiers for carboplatin registration?
Yes. Full CTD Module 3 dossiers are available against NDA, for registration with MHRA (Medicines and Healthcare products Regulatory Agency, UK), GCC central registration, national MoH authorities, BfArM (the German federal institute for drugs) and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. For WHO-PQ-led tenders, the WHO-PQ dossier is handed through as-is. See dossier preparation.
What are typical lead times for carboplatin orders?
Carboplatin is high-rotation stock on most partner lines because it's a WHO EML tender staple. For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. Made-to-order batches including artwork changes run 6-10 weeks inclusive of QC release. Air-freight transit to the UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days. For urgent tender fulfilment, air-freight is the default and the quote reflects that.
Send the specifics. You'll have a price inside one working day.
Strength mix, volume, destination, tender or hospital pharmacy, target delivery. That's the enquiry. Everything else is on us.