Pasireotide API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Signifor, Signifor LAR

Category: Active Pharmaceutical Ingredient

Pasireotide is a synthetic cyclic peptide somatostatin analogue, traded as the diaspartate or pamoate salt. It is sourced by injectable and long-acting product developers, CDMOs and R&D teams.

Product Description:

Pasireotide is a cyclohexapeptide somatostatin analogue that binds several somatostatin receptor subtypes, with particularly high affinity for SSTR5, and reduces the release of ACTH and growth hormone from the pituitary. The diaspartate injection is approved for adults with Cushing's disease for whom pituitary surgery is not an option or has not been curative, and the long-acting pamoate formulation is approved for acromegaly and Cushing's disease (reference brands: Signifor, Signifor LAR).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 0 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 (Dec 2026 (compound patent)). European Union: No confirmed date.

Handling and quality points

Pasireotide contains non-natural amino acids and a cyclic backbone, so the synthesis route, chiral purity of each residue and peptide-related impurities need close review. The salt matters: the diaspartate suits aqueous injections, while the long-acting product uses the pamoate in biodegradable microspheres, so buy the form your formulation needs. Peptide APIs like this are usually stored cold and protected from moisture, so plan temperature-controlled shipping and check the stability data.

Send an API enquiry All specialty APIs

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.