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)
Category: Gastrointestinal Drugs
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.
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. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. 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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Mesalamine (5-Asa) Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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