Relugolix API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Orgovyx, Myfembree, Ryeqo
Category: Active Pharmaceutical Ingredient
Relugolix is an oral non-peptide GnRH receptor antagonist used in prostate cancer and in combination tablets for women's health. It is sourced by formulators, CDMOs and R&D teams.
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Product Description:
Relugolix is a non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist; by blocking the receptor in the pituitary it quickly lowers testosterone in men and oestrogen in women. On its own it is approved for adults with advanced prostate cancer, and in a fixed combination with estradiol and norethisterone acetate it is approved for symptoms of uterine fibroids, including heavy menstrual bleeding, and for endometriosis-associated pain (reference brands: Orgovyx, Myfembree, Ryeqo).
Specification at a glance
| Traded form | Free base; white to off-white or slightly yellow solid, very low water solubility (about 0.04 mg/mL at 25 °C) |
|---|---|
| CAS number | 737789-87-6 |
| Molecular formula | C29H27F2N7O5S |
| Molecular weight | 623.63 g/mol |
| 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 17 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: Patent expiry; entry not confirmed (Jan 2029). European Union: No confirmed date.
Handling and quality points
Relugolix is hormonally active, and suppliers usually make and handle it under containment to protect workers, especially those of reproductive age. Its very low water solubility makes particle size and solid form important for tablet dissolution. The molecule carries a dimethylaminomethyl group, a tertiary amine, so ask for a nitrosamine risk assessment along with related substances and residual solvent 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.
Relugolix API — third party manufacturing & bulk supply
Relugolix 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
Relugolix 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 Relugolix API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Relugolix API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
A GMP certificate, certificate of analysis and specification are the starting point, followed by a US DMF letter of access or EU ASMF for filing. Buyers also ask for solid-form and particle size data, a nitrosamine risk assessment and stability results. If you are developing a combination product, check that impurity methods are suitable alongside the hormone components.
Most suppliers handle it as a potent hormonal compound because it suppresses sex hormones at low exposure. Ask for the occupational exposure band, containment arrangements and cleaning validation, particularly if the site shares equipment with other products.
Yes. PharmaTradz connects licensed manufacturers, CDMOs and R&D teams with GMP-compliant relugolix producers, and we look over the key documents before making introductions. Your identity stays private until there is agreement on both sides.
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