Darolutamide API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Nubeqa
Category: Active Pharmaceutical Ingredient
Darolutamide is a non-steroidal androgen receptor inhibitor used in oral prostate cancer tablets. It is sourced by oncology formulators, CDMOs and generic R&D teams.
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Product Description:
Darolutamide is a non-steroidal androgen receptor inhibitor that blocks androgen binding, movement of the receptor into the cell nucleus and receptor-driven gene activity in prostate cancer cells. It is approved for non-metastatic castration-resistant prostate cancer and for metastatic hormone-sensitive prostate cancer, alongside androgen deprivation therapy and, in some settings, docetaxel (reference brand: Nubeqa).
Specification at a glance
| Traded form | Free base; a mixture of two diastereomers, (S,R) and (S,S), so the diastereomer ratio is part of the specification |
|---|---|
| CAS number | 1297538-32-9 |
| Molecular formula | C19H19ClN6O2 |
| Molecular weight | 398.8 g/mol |
| Pharmacopoeia | No pharmacopoeia monograph found (unverified); supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 8 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 (Oct 2030 (earliest DS patent)). European Union: No confirmed date.
Handling and quality points
As an anti-androgen, darolutamide carries reproductive-toxicity risks, so it is normally handled under potent-compound containment with verified cleaning. Its low water solubility makes particle size and solid form important for dissolution. Because the substance is a defined mixture of two diastereomers, the ratio and any enantiomeric impurities should be controlled and shown to stay steady on stability.
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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.
Darolutamide API — third party manufacturing & bulk supply
Darolutamide 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
Darolutamide 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 Darolutamide API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Darolutamide API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Buyers usually ask for the GMP certificate, a US DMF letter of access or EU ASMF, a CoA showing the diastereomer ratio, particle size and related substances, and stability data. A nitrosamine risk assessment and an ICH M7 assessment for the synthesis are standard. Occupational exposure information is useful for shared facilities.
Darolutamide has two stereocentres and the registered substance is a mixture of the (S,R) and (S,S) diastereomers rather than a single isomer. The ratio needs to fall within the registered range, so suppliers should use a validated method that separates both and the other possible isomers. Ask for batch and stability data showing the ratio stays consistent.
Yes. PharmaTradz puts licensed manufacturers, CDMOs and research teams in touch with GMP-compliant darolutamide makers after reviewing their documents. Your details are only shared once both sides give the go-ahead.
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