Plecanatide API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Trulance
Category: Active Pharmaceutical Ingredient
Plecanatide is a synthetic 16-amino-acid peptide used in tablets for chronic constipation. It is sourced by peptide formulators, CDMOs and R&D groups working on generic versions.
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Product Description:
Plecanatide is a guanylate cyclase-C agonist and a close analogue of uroguanylin, a natural peptide of the gut. It acts locally on the lining of the intestine to increase fluid secretion and help stools pass, with very little reaching the bloodstream. It is approved in the US for adults with chronic idiopathic constipation and for irritable bowel syndrome with constipation (reference brand: Trulance).
Specification at a glance
| Traded form | 16-residue synthetic peptide with two disulfide bridges; amorphous white to off-white powder, soluble in water. Confirm counter-ion and peptide content with the supplier |
|---|---|
| CAS number | 467426-54-6 |
| Molecular formula | C65H104N18O26S4 |
| Molecular weight | 1681.9 g/mol (label: 1682 Da) |
| Pharmacopoeia | No pharmacopoeia monograph found in USP, Ph. Eur., JP, BP or IP (unverified); supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 6 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. 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: Patent expiry; entry not confirmed (Jan 2028 (compound patent)). European Union: No confirmed date.
Handling and quality points
Plecanatide is normally made by peptide synthesis followed by oxidative folding, and the critical quality point is disulfide pairing: mispaired isomers (topoisomers) can form and must be separated and controlled. Ask for peptide content, counter-ion and water content, and for related-peptide impurities by HPLC with mass spectrometry. Like most peptide APIs it picks up moisture and is usually stored cold in tightly closed containers, so plan for temperature-controlled shipping and check the stability data.
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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.
Plecanatide API — third party manufacturing & bulk supply
Plecanatide API 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:
Indicative minimum order quantity
Plecanatide API is supplied as API (drug substance) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Plecanatide API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Plecanatide API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Expect to ask for the GMP certificate, a certificate of analysis with peptide content and impurity profile, and the specification with methods. For the US, a letter of access to the supplier's Type II DMF is the norm; elsewhere, the open part of an ASMF or equivalent dossier. A nitrosamine risk assessment, residual solvent data and real-time stability results under the intended cold storage complete the usual set.
With two disulfide bridges, the peptide can fold into more than one isomer, and only the correct pairing is the intended molecule. Buyers usually ask for an HPLC method that resolves these topoisomers, plus limits for deletion, oxidation and deamidation impurities typical of synthetic peptides.
Yes. PharmaTradz introduces licensed manufacturers, CDMOs and research teams to GMP-compliant peptide API makers, and we check the documentation before anyone is put in touch. Buyer details are kept confidential until both parties agree to proceed.
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