WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Zyloprim (US) and Zyloric (UK) allopurinol is licensed for chronic gout, recurrent uric acid and calcium oxalate stones and tumour lysis prevention in cancer therapy, and it sits on the WHO Model List of Essential Medicines for both the gout and oncology uses, with generic allopurinol tablets registered alongside the originator brands in every market we serve.

M Care Exports supplies Zyloprim (US) and Zyloric (UK), the originator names for allopurinol, a xanthine oxidase inhibitor dosed daily to lower serum urate, alongside FDA- and MHRA-licensed generic allopurinol tablets. It is prescribed for chronic gout prevention, recurrent calcium oxalate stones and, in hospital oncology, to pre-empt tumour lysis syndrome. M Care is a merchant exporter: we source both the brand and generic lines through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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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
Bulk supply and export terms

Allopurinol exporter and bulk supplier from India.

For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes allopurinol against buyer specification: brand (Zyloprim/Zyloric) or generic, 100 mg or 300 mg tablet mix, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because allopurinol is one of the highest-volume, lowest-margin molecules on any NCD formulary, tender desks weigh continuity of supply and batch-level quality over brand differentiation; we confirm the buyer's indication mix, chronic gout versus oncology-supportive prophylaxis, before dispatch and align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

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At a glance

Xanthine oxidase inhibitor; urate-lowering therapy, sourced and documented for export.

Allopurinol is a xanthine oxidase inhibitor: it blocks the enzyme that converts hypoxanthine and xanthine into uric acid, lowering serum urate before crystals form rather than treating an acute flare directly. It is dosed orally, not injected, and needs no reconstitution. The FDA label's flagship indications are management of primary or secondary gout and prevention of uric acid nephropathy in cancer patients receiving cytotoxic therapy that raises serum and urinary uric acid; both the FDA label and the UK SmPC for Zyloric also cover recurrent calcium oxalate renal stones in patients with marked hyperuricosuria, once dietary and fluid measures have failed, with the US label specifying daily uric acid excretion above 800 mg in men or 750 mg in women as the threshold for this use. Allopurinol is not used to treat an acute gout attack and can worsen one if started during a flare. Zyloprim/Zyloric is supplied as 100 mg and 300 mg scored tablets, taken once daily and titrated against serum urate response.

Active ingredient

Allopurinol. Xanthine oxidase inhibitor; urate-lowering therapy.

Forms and strengths

100 mg scored tablet; 300 mg scored tablet.

Indications

Allopurinol, a xanthine oxidase inhibitor that lowers serum urate, licensed for chronic gout prevention, recurrent calcium oxalate renal stones and prophylaxis of tumour lysis syndrome in cancer therapy. Supplied as originator Zyloprim/Zyloric and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral. Scored tablet.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

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

Buyers for allopurinol are hospital rheumatology and general-medicine outpatient pharmacies running a chronic gout formulary, oncology pharmacies stocking a tumour-lysis-prevention protocol alongside rasburicase or hydration orders, national and regional MoH tender desks running non-communicable-disease and chronic-medicine procurement lists, NGO and foundation programmes supporting NCD access where allopurinol's WHO Essential Medicines listing makes it a standing formulary item, and licensed pharmaceutical wholesalers and importers supplying retail and hospital channels across our GCC and African markets.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on allopurinol.

Dosing starts low, 100 mg once daily, and titrates upward in 100 mg weekly steps until serum uric acid falls to 6 mg/dL or below, with maintenance typically 200-300 mg daily for mild gout and 400-600 mg daily for moderate-to-severe disease; US labelling caps the dose at 800 mg daily. Renal impairment demands real adjustment, not a rounding-down: US labelling scales to 200 mg daily at creatinine clearance 10-20 mL/min and 100 mg daily or less below 10 mL/min, while UK guidance targets a plasma oxipurinol level under 100 micromol/litre in severe renal insufficiency, so confirm the destination prescriber's protocol before a large tender fill. The dispensing flag that matters most is skin reaction: allopurinol should stop at the first sign of rash, as Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome have all been reported, more frequently in HLA-B*5801 carriers, a variant more common in Han Chinese, Thai and Korean populations, and a patient who has had a severe reaction should never be rechallenged. Co-prescription with azathioprine or mercaptopurine needs the companion drug's dose cut to a quarter to a third, since allopurinol blocks the same enzyme pathway that clears them. No cold chain and no reconstitution are required; 300 mg tablets should be kept out of direct light per the US label.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid dosage form, allopurinol travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product; UK shelf life runs 5 years stored below 25°C in original packaging, per the Zyloric SmPC. Allopurinol has sat on the WHO Model List of Essential Medicines since 1977 for gout and since 2007 for tumour lysis prevention, one of the few molecules on our roster with a dual EML listing spanning a chronic NCD indication and an oncology-supportive one; it does not carry an AWaRe classification, since that framework applies to antibiotics only. On the brand-versus-generic question, Zyloprim (US) and Zyloric (UK) remain the long-standing originator names, but allopurinol has been off-patent for decades and FDA- and MHRA-approved generic allopurinol 100 mg and 300 mg tablets from multiple manufacturers are the dominant supply on most formularies; buyers genuinely have a brand-or-generic choice, and most tender desks specify generic by default given the price differential on such a high-volume molecule. Allopurinol is not a controlled substance in the markets we currently review.

How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

How the enquiry works

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

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for allopurinol.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Allopurinol supply, the specific questions.

Does a generic version of Zyloprim/Zyloric exist?

Yes, and it is the dominant supply. Allopurinol has been off-patent for decades, and FDA- and MHRA-approved generic allopurinol 100 mg and 300 mg tablets from multiple manufacturers are registered and marketed in the US and UK alongside the Zyloprim and Zyloric brand names. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.

What is allopurinol licensed to treat?

US labelling covers management of primary or secondary gout, prevention of uric acid nephropathy in cancer patients receiving cytotoxic therapy that raises serum and urinary uric acid, and recurrent calcium oxalate renal stones with marked hyperuricosuria. UK labelling for Zyloric mirrors the stone indication with the same wording. It is a urate-lowering therapy for chronic prevention, not a treatment for an acute gout flare.

Is allopurinol on the WHO Essential Medicines List?

Yes, twice over. Allopurinol was first added to the WHO Model List of Essential Medicines in 1977 for gout management and again in 2007 for tumour lysis prevention in cancer supportive care, one of the few molecules with a listing spanning both a chronic non-communicable-disease use and an oncology-supportive one. It does not carry an AWaRe classification, which applies to antibiotics only.

What strengths of allopurinol does M Care supply?

100 mg and 300 mg scored tablets, matching the Zyloprim and Zyloric strengths. Dosing starts at 100 mg daily and titrates upward against serum urate response, so tell us your indication mix, chronic gout or oncology tumour-lysis prophylaxis, and we quote the strength split accordingly.

What is the main safety concern with allopurinol?

Severe skin reactions. Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome have all been reported, more frequently in carriers of the HLA-B*5801 genetic variant, which is more common in Han Chinese, Thai and Korean populations. Therapy should stop immediately at the first sign of rash, and a patient with a documented severe reaction should never be restarted on allopurinol.

What documentation does M Care provide with an allopurinol shipment?

Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import, along with confirmation of which brand or generic product a shipment contains.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Allopurinol enquiry

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