Mesalamine (5-ASA) tablets bulk supplier for pharma manufacturers

Mesalamine (5-ASA) Tablets 400 mg, 500 mg, and 1 g Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 400 mg, 500 mg, and 1 g

Reference Brands: Asacol HD, Lialda, Pentasa(US)

Mesalamine (5-ASA) tablets and capsules are anti-inflammatory agents that release in the intestine, reducing inflammation by inhibiting prostaglandin synthesis. They effectively treat ulcerative colitis and Crohn’s disease, providing symptom relief, mucosal healing, and improved quality of life. Benefits include decreased inflammation, fewer flares, and better disease control.

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Product Description: Mesalamine (5-ASA) tablets and capsules, marketed as Asacol, Pentasa, and Lialda, are approved in the US by the FDA and in the EU via EMA for ulcerative colitis and Crohn’s disease. Approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data for prompt approval, while the EMA ensures compliance with regional safety and manufacturing regulations. Proper regional compliance supports timely approval, safe use, and worldwide availability, helping improve patient outcomes for inflammatory bowel diseases globally.

Mesalamine (5-ASA) Tablets — third party manufacturing & bulk supply

Mesalamine (5-ASA) Tablets 400 mg, 500 mg, and 1 g is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Mesalamine (5-ASA) Tablets is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Mesalamine (5-ASA) Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Mesalamine (5-ASA) tablets is listed as Tablets in 400 mg, 500 mg, and 1 g. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Mesalamine (5-ASA) tablets is referenced against Asacol HD, Lialda, Pentasa(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.