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Nirogacestat bulk supplier for pharma manufacturers

Nirogacestat 50 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 50 mg

Reference Brands: Generic formulations marketed under different names

Category: Oncology Cancer Care

Nirogacestat is a Oncology Cancer Care product available as Tablets in strengths 50 mg. It corresponds to the reference brand Generic formulations marketed under different names. Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Nirogacestat is an oral anti-cancer medication approved for the treatment of desmoid tumors, a rare and locally aggressive type of soft tissue tumor. It is a selective gamma-secretase inhibitor that works by blocking the Notch signaling pathway, which plays a critical role in tumor cell growth and survival. By inhibiting this pathway, nirogacestat helps slow tumor progression and reduce disease-related symptoms.

Marketed under the brand name Ogsiveo, nirogacestat was approved for medical use in the United States in November 2023. It is the first medication approved by the US Food and Drug Administration (FDA) specifically for the treatment of desmoid tumors, representing a significant advancement in targeted cancer therapy. The drug is administered orally, making it a convenient option for long-term treatment compared to invasive therapies.

Nirogacestat has shown meaningful clinical benefits in patients with progressive or symptomatic desmoid tumors, including tumor size reduction and improved quality of life. Its approval provides a targeted, non-surgical treatment option for patients who previously had limited therapeutic choices, supporting personalized and effective oncology care.

Nirogacestat — third party manufacturing & bulk supply

Nirogacestat 50 mg 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Nirogacestat listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions


Nirogacestat is an investigational drug used for the treatment of desmoid tumors (aggressive fibromatosis) and other solid tumors. It is designed to inhibit tumor growth in patients with progressive or symptomatic disease.


Nirogacestat is a small-molecule gamma-secretase inhibitor that blocks the Notch signaling pathway, which is implicated in tumor cell proliferation and survival.


Nirogacestat does not yet have a widely approved trade name, as it is still in clinical development.


Nirogacestat is developed by SpringWorks Therapeutics.


The generic name is nirogacestat.


Currently, there is no approved brand name.


Nirogacestat is manufactured in clinical-grade facilities under the oversight of SpringWorks Therapeutics for clinical trials.

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