Capecitabine tablets — supplier from India to the UK, GCC and Africa.

An oral fluoropyrimidine prodrug of 5-FU for colorectal, gastric and breast cancer. 150mg and 500mg film-coated tablets from Indian WHO-GMP partner sites, with the CTD dossier, DPD-screening counselling pack and regulatory file an oncology pharmacy expects.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
At a glance

Multiple WHO-GMP partner lines · 150mg and 500mg film-coated tablets · full CTD dossier on file.

Active ingredient

Capecitabine (fluoropyrimidine antimetabolite). Mechanism: oral prodrug of 5-fluorouracil, activated sequentially by carboxylesterase in the liver, cytidine deaminase, then thymidine phosphorylase — the last enzyme preferentially expressed in tumour tissue for localised 5-FU generation.

Strengths stocked

150mg and 500mg film-coated tablets. Oral administration. BSA-calculated dosing at 1250 mg/m² twice daily on the standard 14-days-on / 7-days-off cycle; dual-strength packs let pharmacy dispense the exact per-dose combination without tablet splitting.

Indications

Adjuvant stage III colon cancer; first-line metastatic colorectal cancer (monotherapy or with oxaliplatin as CAPOX / XELOX); first-line advanced gastric cancer with platinum; locally advanced or metastatic breast cancer (post-taxane / anthracycline) as monotherapy or with docetaxel.

Storage

Store below 30°C in the original container. No cold-chain required — capecitabine ships as ambient pharmaceutical freight. HDPE bottles are desiccant-free; blister wallets protect against humidity for the full shelf life.

Shelf life

36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.

Pack format

HDPE bottle with child-resistant closure (60 or 120 tablets) for community-pharmacy dispensing; PVC/PVdC-Aluminium blister wallets of 120 tablets for NHS 14-day cycles. Destination-language PIL and cytotoxic-drug handling leaflet co-packed.

Who we supply

Hospital pharmacies, importers and tender desks across twenty markets.

India is our origin. We do not sell into the Indian market. Capecitabine is exported only.

United Kingdom

NHS oncology pharmacies and specialist importers under MHRA (Medicines and Healthcare products Regulatory Agency) Specials / named-patient import where licensed stock is short. Community oncology pharmacies fulfilling take-home CAPOX and monotherapy regimens supplied through licensed UK wholesalers. DPYD screening-protocol references included with the pack.

Named-patient import, UK →

GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)

Through local licensed importers, against MoH tender awards and hospital pharmacy purchase orders. CTD dossiers prepared for national registration with SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and the GCC central registration pathway. Arabic-language PIL and blister-wallet artwork prepared for MoH review.

MoH registration, GCC →

Nigeria, Kenya, Ghana, South Africa

Public-sector oncology tenders (NAFDAC Nigeria, KEMSA Kenya, CMS Ghana, SAHPRA South Africa), teaching-hospital supply and NGO procurement. Capecitabine features on essential oncology lists in each market. Global Fund and UICC Access to Oncology Medicines buyers catered for separately with WHO-PQ-style documentation.

Germany

Supply through licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM (Federal Institute for Drugs and Medical Devices) recognition. German-language PIL matches the EMA reference SmPC including DPD-deficiency contraindication wording.

Pharmacist's note

What the dispensing pharmacist actually counsels on.

Capecitabine dosing is BSA-based at 1250 mg/m² twice daily, morning and evening, for 14 days followed by a 7-day rest — taken within 30 minutes after a meal with water. Fasted-state intake spikes Cmax and worsens tolerability, so pharmacy should reinforce the post-food rule at every dispense. Hand-foot syndrome (palmar-plantar erythrodysaesthesia) is the dose-limiting toxicity: counsel on liberal emollient use from day one, dose-interrupt at grade 2, and permanently dose-reduce at grade 3. DPD (dihydropyrimidine dehydrogenase) screening has been an MHRA and EMA requirement since March 2020 — patients with complete or near-complete DPYD deficiency face life-threatening toxicity and need pre-treatment genotype or phenotype testing. Watch the warfarin interaction (significant INR rise; dose-reduce or switch to LMWH) and phenytoin (levels elevate; monitor). Tablets must not be crushed or split — capecitabine is a hazardous drug and requires cytotoxic handling.

Regulatory & quality

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 dissolution-profile comparatives included.

CoA and MoA, per batch

HPLC assay, related substances (including 5'-DFUR and 5-FU limits), dissolution per USP and Ph. Eur., water content, residual solvents and microbial limits — 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 to MHRA SmPC, EMA, SFDA, MOHAP, SAHPRA or BfArM style. DPD-deficiency contraindication and hand-foot syndrome counselling text included verbatim from the reference label. Artwork QC before print, not after.

Temperature control

Pre-shipment thermal validation confirms the below-30°C ambient specification holds through worst-case transit routes. In-transit logging where the tender requires it; on-arrival record filed. No cold-chain validated lanes needed for capecitabine — standard ambient pharmaceutical freight.

Pharmacovigilance

Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C, with DPYD-related serious-adverse-event reporting on the standard 15-day expedited track.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Strength split (150mg vs 500mg tablet counts), pack format preference (HDPE bottle or blister wallet), destination market, tender or hospital pharmacy, and the target delivery window.
  2. We route to the right line. Multiple WHO-GMP partner lines sit on our roster for capecitabine. Registered-market preference goes to facilities with in-country registration; cost-sensitive tender work goes to lines with the right price point.
  3. 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 — including the DPD-screening reference insert. Inside one working day.
  4. Order, produce, release, ship. QC release on the Indian side with dissolution and HPLC assay on the release certificate. No cold-chain validated lanes required — standard ambient pharmaceutical freight with desiccated outer cartons.
  5. After delivery. Batch records, CoA and dispatch logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; DPYD-related adverse-event reporting on the standard 15-day expedited track.
Frequently asked

Capecitabine supply — the specific questions.

What strengths of capecitabine do you supply?

Capecitabine is supplied as 150mg and 500mg film-coated tablets — the two standard strengths worldwide. 150mg is used primarily for dose-titration around the 14-day cycle; 500mg is the workhorse strength for the 1250 mg/m² twice-daily standard. Pack formats are HDPE bottles with child-resistant closure (60 or 120 tablets) or PVC/PVdC-Aluminium blister wallets of 120 tablets that align to an NHS 14-day cycle. Multi-pack hospital cartons are available against firm orders.

How should pharmacy teams counsel patients on hand-foot syndrome?

Hand-foot syndrome (palmar-plantar erythrodysaesthesia) is the dose-limiting toxicity of capecitabine and the single biggest reason patients interrupt therapy. Counsel at dispense: liberal emollient from day one, avoid tight-fitting shoes, hot water and friction, and keep hands and feet cool. Escalation is protocol-driven — at grade 2 (painful erythema, swelling, interfering with activities) dose-interrupt until resolved to grade 0-1; at grade 3 (moist desquamation, severe pain, unable to perform daily tasks) permanent dose-reduction is required. A counselling leaflet written to MHRA SmPC wording is co-packed with every dispatch.

Do you include DPD-deficiency screening guidance with shipments?

Yes. Since March 2020 the MHRA and EMA have required DPYD (dihydropyrimidine dehydrogenase) testing before starting capecitabine — patients with complete or near-complete DPD deficiency develop severe, sometimes fatal toxicity at standard doses. Our destination-language pack inserts carry the DPD contraindication text verbatim from the reference SmPC, and we include a pharmacist-facing reference insert summarising the four common DPYD variants (*2A, *13, D949V, HapB3) and the recommended genotype-led dose adjustment. We supply the product, not the testing, but we make sure the counselling context ships with it.

Which markets can you ship capecitabine into?

We routinely ship capecitabine into the UK (named-patient / MHRA specials and licensed wholesale where applicable), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — tender and teaching-hospital supply), and Germany (§72 AMG import channels). Capecitabine features on essential oncology lists in every African market we serve. We do not supply into India.

What documentation is included with a capecitabine consignment?

Every consignment ships with a batch-specific Certificate of Analysis (including HPLC assay, related substances, dissolution and residual solvents), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language PIL with DPD-deficiency and hand-foot syndrome text, cytotoxic handling leaflet, and dispatch records. Full list under oncology.

Does capecitabine need a cold-chain or any temperature-controlled lane?

No. Capecitabine tablets store below 30°C in the original container and ship as standard ambient pharmaceutical freight — the same regime as any oral solid dosage form. Thermal validation is run on the shipper configuration to confirm below-30°C across worst-case routes, and in-transit logging is added where the tender specifies it, but no cold-chain validated lanes are required. This is a meaningful cost and logistics advantage over the injectable fluoropyrimidine 5-FU, which ships as a refrigerated or frozen vial at 2-8°C.

What are typical lead times for capecitabine orders?

For registered markets with stock on hand, dispatch is typically 5-10 working days. Made-to-order batches, 6-10 weeks inclusive of QC release, dissolution testing and destination-specific artwork approval. Air-freight transit to the UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days. Tablet format makes sea freight commercially viable at tender volumes, which is rarely the case for temperature-controlled oncology injectables.

Capecitabine enquiry

Send the specifics. You'll have a price inside one working day.

Strength split, pack format, destination, tender or hospital pharmacy, target delivery. That's the enquiry. Everything else is on us.

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