Salofalk and Pentasa (mesalazine, known as mesalamine in the US) are licensed for induction and maintenance of remission in mild to moderate ulcerative colitis, and licensed generic mesalazine lines now sit alongside the originator brands, though the two are not interchangeable because each releases its 5-ASA at a different point in the gut.
M Care Exports supplies mesalazine, marketed internationally as Salofalk (Dr Falk Pharma) and Pentasa (Ferring), alongside other licensed alternative-release brands such as Asacol MR and Mezavant XL, and licensed generic mesalazine tablets, granules and suppositories. Mesalazine (called mesalamine in US labelling) is the first-line 5-aminosalicylic acid therapy for mild to moderate ulcerative colitis, dosed differently by brand because each formulation is engineered to release in a different part of the gut. M Care is a merchant exporter: we source these brands and their generics through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Mesalazine exporter and bulk supplier from India.
For hospital gastroenterology pharmacy, wholesaler and tender-desk orders, M Care quotes mesalazine against buyer specification: brand (Salofalk, Pentasa, Asacol MR, Mezavant XL or a locally-registered equivalent) or generic, dosage form (delayed- or prolonged-release tablet, prolonged-release granules or suppository) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because mesalazine formulations are not clinically interchangeable, a switch between brands changes where the drug releases in the gut, so we confirm the buyer's exact brand or formulation before dispatch rather than substituting a different mesalazine product against the same order, then 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.
Aminosalicylate anti-inflammatory, topically-acting on colonic and rectal mucosa, sourced and documented for export.
Mesalazine, mesalamine in US nomenclature, is 5-aminosalicylic acid (5-ASA), an anti-inflammatory that acts topically on the colonic and rectal mucosa rather than through significant systemic absorption, most likely by inhibiting prostaglandin and leukotriene synthesis in the gut wall. Because its effect depends on local contact with inflamed tissue, manufacturers have built distinct delivery systems: Salofalk uses a pH-dependent Eudragit coating that releases from the terminal ileum onward, Pentasa uses an ethylcellulose-coated microgranule that releases in a time- and pH-independent manner starting in the duodenum, Asacol MR uses an acrylic-resin coating that also delays release until the terminal ileum, and Mezavant XL, built on MMX (multi-matrix system) technology, releases across the whole colon from a single once-daily dose once its coating dissolves above pH 7. The FDA label for Pentasa confirms the flagship indication as induction of remission in mildly to moderately active ulcerative colitis; the MHRA-approved SmPC for Salofalk covers acute-episode treatment and maintenance of remission in mild to moderate ulcerative colitis but explicitly does not extend to Crohn's disease, while the Asacol MR SmPC additionally covers maintenance of remission in Crohn's ileocolitis. Rectal mesalazine (suppositories) is licensed separately for distal disease, proctitis and left-sided colitis, and is typically combined with oral therapy for more extensive disease.
Active ingredient
5-aminosalicylic acid (5-ASA). Aminosalicylate anti-inflammatory, topically-acting on colonic and rectal mucosa.
Forms and strengths
250 mg controlled-release capsule; 500 mg controlled-release capsule; 3 g prolonged-release granule sachet; 500 mg suppository.
Indications
Mesalazine (mesalamine in the US), an aminosalicylate that acts topically on the colonic and rectal mucosa, indicated for induction and maintenance of remission in mild to moderate ulcerative colitis and, in rectal forms, for distal colitis and proctitis. Supplied as originator brands Salofalk and Pentasa, alternative-release brands including Asacol MR and Mezavant XL, and licensed generic lines from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral, Rectal. Prolonged/delayed-release tablets and granules, controlled-release capsules and suppositories.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
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 mesalazine are mainly hospital and outpatient gastroenterology pharmacies managing ulcerative colitis patients on long-term maintenance therapy, national and regional MoH tender desks running gastrointestinal and NCD formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting chronic-disease access in markets where local registration for a Salofalk, Pentasa or generic mesalazine line is already in place.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on mesalazine.
Mesalazine dosing is brand-specific and should never be converted milligram-for-milligram between products: Salofalk granules are dosed at 1.5 to 3g once daily, taken in the morning or split into three doses, while Pentasa capsules are dosed up to 4g daily in four divided doses for active disease, so a tender specification naming one brand should not be substituted with another mesalazine line without re-confirming the dose. Renal function should be checked before starting therapy and monitored periodically thereafter (Salofalk's SmPC specifies a follow-up test at 14 days, then further tests at four-weekly intervals, moving to three-monthly once stable), because mesalazine-induced nephrotoxicity, while uncommon, warrants immediate discontinuation if renal function deteriorates. Watch for mesalamine-induced acute intolerance syndrome, cramping, worsening bloody diarrhoea, fever and rash that mimics a disease flare but is actually a drug reaction, and for rare mesalazine-associated pericarditis. Serious blood dyscrasias have been reported very rarely; unexplained bruising, bleeding or fever should prompt a full blood count. No cold-chain handling or reconstitution is required for any oral or rectal mesalazine formulation.
The documentation pack a regulator actually asks for.
As oral solid or rectal dosage forms, mesalazine products travel on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; Salofalk's SmPC states no special storage conditions and a four-year shelf life. 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, since brand-specific release technology (pH-dependent coating, time-dependent microgranule or MMX matrix) is a dossier detail regulators check closely. On the WHO Essential Medicines List, mesalazine is listed as a therapeutic alternative to sulfasalazine for inflammatory bowel disease; it carries no AWaRe classification because that framework applies only to antimicrobials. Mesalazine is not a controlled substance. On the brand-versus-generic question, Salofalk (Dr Falk Pharma) and Pentasa (Ferring) are established originator brands, alongside alternative-release brands Asacol MR and Mezavant XL; FDA- and MHRA-approved generic mesalazine tablets, granules and suppositories are separately registered in the US, UK and EU. The SmPCs for these products are explicit that the formulations are not interchangeable and should be prescribed and supplied by proprietary name, because switching brands changes where in the gut the drug is released, so buyers genuinely have a brand-or-generic choice but not a brand-to-brand one. M Care confirms the exact brand or generic line named in a tender before quoting and does not offer a different mesalazine product as a substitute.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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.
Adjacent lines procurement desks order alongside mesalazine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for mesalazine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Mesalazine supply, the specific questions.
Are Salofalk, Pentasa and generic mesalazine interchangeable?
No. Each mesalazine brand uses a different release technology: Salofalk releases pH-dependently from the terminal ileum, Pentasa releases time-dependently from the duodenum, Asacol MR also delays release until the terminal ileum, and Mezavant XL releases across the whole colon from a single daily dose using MMX technology. Because switching between them changes where the drug reaches inflamed tissue, the SmPCs for these products recommend prescribing and supplying mesalazine by proprietary name. M Care supplies the exact brand or generic line a buyer specifies rather than offering a different mesalazine product as a substitute.
Can M Care supply Salofalk or Pentasa to our market?
Yes, on an import basis. We source Salofalk through Dr Falk Pharma's and Pentasa through Ferring's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What dosage forms and strengths of mesalazine are available?
Prolonged-release granules in sachets (Salofalk, 3g strength confirmed on the product SmPC we reviewed, with other sachet sizes available from the manufacturer), controlled-release capsules (Pentasa, 250mg and 500mg), alternative-release tablets (Asacol MR and Mezavant XL), and rectal suppositories (500mg). Tell us your indication, extent of colitis and preferred brand or generic and we quote the matching formulation.
Does a generic version of mesalazine exist?
Yes. FDA- and MHRA-approved generic mesalazine tablets, granules and suppositories are registered and marketed in the US, UK and EU alongside originator and alternative-release brands such as Salofalk, Pentasa, Asacol MR and Mezavant XL. Because the formulations are not clinically interchangeable, we confirm which specific brand or generic line a buyer needs rather than treating any mesalazine product as a like-for-like swap.
Is mesalazine licensed for Crohn's disease as well as ulcerative colitis?
This depends on the specific product and destination-country labelling. The Salofalk SmPC we reviewed licenses the product for acute treatment and maintenance of remission in mild to moderate ulcerative colitis only, not Crohn's disease, while the Asacol MR SmPC additionally covers maintenance of remission in Crohn's ileocolitis. Buyers should check the label of the specific brand or generic they are sourcing rather than assuming one product's licensed indications apply across all mesalazine brands.
What should a hospital pharmacy monitor during mesalazine therapy?
Renal function before starting and periodically during treatment, since mesalazine-induced nephrotoxicity, though uncommon, requires immediate discontinuation if it occurs. Prescribers should also watch for mesalamine-induced acute intolerance syndrome, a drug reaction that mimics a disease flare with cramping and bloody diarrhoea, and for the rare occurrence of pericarditis or blood dyscrasias.
What documentation does M Care provide with a mesalazine 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 of the specific brand or generic formulation and its release technology.
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.
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