Degarelix Acetate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Firmagon

Category: Active Pharmaceutical Ingredient

Degarelix acetate is a synthetic decapeptide GnRH antagonist used in depot injections for advanced prostate cancer. It is sourced by peptide formulators, CDMOs and R&D teams.

Product Description:

Degarelix is a synthetic linear decapeptide that blocks the gonadotrophin-releasing hormone (GnRH) receptor in the pituitary, quickly reducing testosterone production without the initial surge seen with GnRH agonists. It is approved for the treatment of advanced prostate cancer (reference brand: Firmagon).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 9 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 (to 2032 (non-compound patents)). European Union: Generics/biosimilars on the market (authorised Sep 2023).

Handling and quality points

Degarelix is made by peptide synthesis, so review the route and the impurity profile: deletion, insertion and racemised sequences, the hydantoin rearrangement product of the dihydroorotyl residue, counter-ion and water content, and the peptide content assay. The acetate is hygroscopic and amorphous, and the EU generic assessment reports long-term stability studies at 5 °C, so plan refrigerated storage and shipping unless the supplier's data support otherwise. Because the finished product forms a depot after injection, physical attributes such as aggregation behaviour are worth discussing as well.

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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.