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

Sevelamer carbonate, exported for dialysis-unit and CKD-MBD formularies.

M Care Exports supplies sevelamer carbonate as 800 mg film-coated tablets and as 0.8 g / 2.4 g powder for oral suspension, sourced from licensed Indian WHO-GMP manufacturers for hospital pharmacies, dialysis units and MoH tender desks managing hyperphosphataemia in chronic kidney disease.

Also marketed as Renagel and Renvela.

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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

Sevelamer exporter and bulk supplier from India.

Dialysis units order sevelamer by the pallet, not the pack: monthly maintenance dosing runs to several grams a day per patient across a renal unit's caseload. M Care quotes tablet and powder formulations side by side against tender volumes, with WHO-GMP CoA and MoA issued per batch.

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

Non-calcium, non-absorbed phosphate-binding polymer, sourced and documented for export.

A non-calcium, non-absorbed phosphate binder for renal-unit formularies: no cold chain, 3-year shelf life, tablet and swallow-friendly powder both on the roster.

Active ingredient

Sevelamer carbonate (also supplied as sevelamer hydrochloride). Non-calcium, non-absorbed phosphate-binding polymer.

Forms and strengths

800 mg film-coated tablet; 0.8 g powder for oral suspension; 2.4 g powder for oral suspension.

Indications

Sevelamer carbonate is a calcium-free, non-absorbed polymer that binds dietary phosphate in the gastrointestinal tract, used to control serum phosphorus in chronic kidney disease. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated export markets.

Administration

Oral. Film-coated tablet and powder for oral suspension.

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.

Renal-unit pharmacy leads, MoH tender desks in the GCC and Africa, and licensed importers across M Care's 49 export markets. Sevelamer moves through dialysis-centre formularies and hospital procurement, not retail pharmacy, so orders are quoted against tender volumes and delivery schedules rather than shelf stock.

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 sevelamer.

Sevelamer carbonate is dosed against measured serum phosphorus, not weight: adults typically start at 0.8 g or 1.6 g three times daily with meals, titrated in 0.8 g increments at two-to-four-week intervals against monitoring. Ambient storage only, no cold chain: emc lists a 3-year shelf life for the tablet, with the bottle kept tightly closed against moisture rather than any temperature restriction. The main formulation question we get from renal pharmacies is tablet versus powder: uncommon but real reports of tablet retention and swallowing difficulty in patients with oesophageal motility problems push some units toward the oral suspension powder as a standing alternative rather than an exception. Because sevelamer binds in the gut, dosing is typically separated by an interval from other oral medicines with a narrow therapeutic index, ciprofloxacin among them, per the product literature's administration guidance rather than a fixed universal rule.

Regulatory & quality

The documentation pack a regulator actually asks for.

Every batch ships with a Certificate of Analysis and Certificate of Manufacture from a CDSCO-licensed, WHO-GMP-audited Indian site, alongside CTD Module 3 CMC documentation and destination-language pack inserts. Temperature-controlled dispatch is not required for sevelamer, but M Care still logs in-transit conditions and batch traceability the same way it does for cold-chain lines, so the paperwork a tender desk or importer's regulatory team asks for is already assembled before the enquiry closes.

The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.

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 sevelamer.
  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

Sevelamer supply, the specific questions.

What is sevelamer used for?

Sevelamer carbonate is a non-calcium, non-absorbed phosphate binder used to control serum phosphorus in patients with chronic kidney disease. The FDA label covers adults and children aged 6 and over on dialysis; the UK and EU SmPC additionally covers adults with CKD not yet on dialysis when phosphorus is elevated. It works by binding dietary phosphate in the gut so it is excreted rather than absorbed.

Is sevelamer the same as Renvela?

Renvela is the originator brand name for sevelamer carbonate; Renagel is the related originator brand of sevelamer hydrochloride. Licensed generic sevelamer carbonate and sevelamer hydrochloride tablets are now approved in the US, UK and EU. Buyers can choose branded Renvela-pattern supply or a licensed generic depending on tender specification.

What strengths and formulations does M Care supply?

M Care sources sevelamer carbonate as 800 mg film-coated tablets and as powder for oral suspension in 0.8 g and 2.4 g sachets, matching the strengths and dosage forms in the originator's regulatory filings. The powder is the usual fallback for patients who cannot tolerate the tablet.

Does sevelamer need cold-chain shipping?

No. Sevelamer carbonate tablets and powder are stored at room temperature with no special temperature requirement; the manufacturer's SmPC asks only that the container be kept tightly closed to protect the contents from moisture. M Care ships it as an ambient line, with a 3-year shelf life at dispatch, which simplifies logistics for markets without validated cold-chain warehousing.

Is sevelamer on the WHO Essential Medicines List?

No. Sevelamer does not appear on the WHO Model List of Essential Medicines; calcium-based binders such as calcium carbonate and calcium acetate are the phosphate binders on that list. Sevelamer is nonetheless a KDIGO 2017 CKD-MBD guideline-recognised option and a standard line on tertiary nephrology and dialysis-unit formularies, procured separately from EML-driven primary-care tenders.

Can sevelamer be taken with other medicines?

Sevelamer binds in the gastrointestinal tract, so product labelling advises separating its administration from oral medicines where reduced absorption would matter clinically, ciprofloxacin among the examples named in the prescribing information. A hospital pharmacist should set the dosing schedule against the full medicines list, not a fixed universal gap, since the interval named varies by interacting drug.

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 2026-09-14.

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.

Sevelamer enquiry

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