Darolutamide Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 300 mg
Reference Brands: Nubeqa (USA/EU)
Category: Oncology Cancer Care
Darolutamide is available in Tablets and strengths such as 300 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Darolutamide is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Darolutamide can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Darolutamide, marketed under the brand name Nubeqa, is a nonsteroidal antiandrogen used for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men. It is specifically indicated for patients whose disease progresses despite surgical or medical castration, helping to slow tumor growth and delay metastasis. Darolutamide works by selectively binding to androgen receptors, inhibiting androgen-mediated signaling that contributes to prostate cancer cell proliferation. This mechanism helps reduce the stimulation of cancer cells by male hormones, providing effective disease control. The medication is administered orally, typically as a 300 mg tablet taken twice daily with food, ensuring optimal absorption and consistent plasma levels. Darolutamide has been shown to have a favorable safety profile, with fewer central nervous system-related side effects compared to other antiandrogens, while common adverse effects may include fatigue, joint pain, and elevated liver enzymes. Its oral route, targeted action, and manageable tolerability make darolutamide a valuable option for men with nmCRPC seeking to maintain quality of life while effectively managing disease progression. Regular monitoring by healthcare professionals ensures safe and effective therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Darolutamide is used for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men.
It is a nonsteroidal antiandrogen that inhibits androgen receptor signaling, slowing prostate cancer growth.
The trade name is Nubeqa.
Darolutamide is manufactured by Bayer Pharmaceuticals.
The generic name is darolutamide.
The brand name is Nubeqa.
It is manufactured in facilities complying with international regulatory standards for oncology medications.
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