Linaclotide API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Linzess, Constella

Category: Active Pharmaceutical Ingredient

Linaclotide is a 14-amino-acid peptide with three disulfide bridges used in oral constipation products. It is sourced by peptide formulators, CDMOs and generic R&D teams.

Product Description:

Linaclotide is a synthetic 14-amino-acid peptide with three disulfide bridges that activates guanylate cyclase-C on the lining of the gut, which increases fluid secretion and speeds transit. In the US it is approved for irritable bowel syndrome with constipation in adults and children aged 7 and older, chronic idiopathic constipation in adults, and functional constipation in children aged 2 and older. In the EU it is approved for moderate to severe irritable bowel syndrome with constipation in adults (reference brand: Linzess, Constella).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 16 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Entry expected (Mar 2029 (settlements)). European Union: No confirmed date (2027-2036).

Handling and quality points

Linaclotide is made by solid-phase or hybrid peptide synthesis followed by oxidative folding, and the main quality risk is mispaired disulfide isomers alongside deletion, oxidation and deamidation impurities. The finished capsules contain only a small amount of peptide, so formulators need low-level impurity methods and good content uniformity. The peptide is sensitive to moisture and heat, so expect cold, dry storage in sealed containers.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.