Darolutamide API Powder

Xi'an Faithful BioTech Co., Ltd: Your Trusted Darolutamide API Powder Manufacturer & Supplier

Xi'an Faithful BioTech Co., Ltd focuses on providing high value-added specialty active pharmaceutical ingredients to the global market. We are committed to bridging the gap between high-quality Chinese manufacturing and global pharmaceutical markets，Darolutamide API Powder is one of our advantage products.

Darolutamide API Powder Introduction

Darolutamide API Powder is a nonsteroidal hormone receptor antagonist used to treat non metastatic castration resistant prostate cancer. This white powder mainly exerts its therapeutic effect by selectively inhibiting the nuclear transport of sex hormone receptors. It has demonstrated excellent targeting and safety in clinical practice.

Specifications

Application area

Darolutamide API Powder is mainly used for the preparation of oral solid preparations (tablets) for the treatment of prostate cancer, and its core indications include:

1. Non metastatic castration resistant prostate cancer (nmCRPC)

For patients with elevated PSA levels after ADT treatment but without distant metastasis, it can delay metastasis.

2. Treatment of metastatic hormone sensitive prostate cancer (mHSPC)

Combined with ADT and Docetaxel chemotherapy, the biological triple therapy regimen reduces the risk of patient mortality by 32% and prolongs the median overall survival by nearly 2 years compared to standard ADT combined chemotherapy.

3. Other extended applications

Localized prostate cancer and recurrent prostate cancer are currently in phase III clinical research.

Main Advantages Darolutamide API Powder

Safety

• The permeability of the blood-brain barrier is extremely low, significantly reducing the central nervous system side effects such as epilepsy and fatigue commonly seen in traditional drugs.

Potent

• Hormone receptors have extremely high affinity (Ki=11nM) and are even effective against some drug-resistant mutants.

Accurate therapeutic effect

• In the ARAMIS trial, the median metastasis free survival (MFS) was extended by up to 22 months.

Policy-driven

• In China,it has been included in the medical insurance catalog, with a significant increase in terminal volume and stable growth in raw material demand.

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Why choose us

The synthesis route of Darolutamide API Powder is long, with multiple chiral centers and extremely high requirements for controlling isomer impurities. The factories we cooperate with strictly follow the process parameters for production, ensuring that they closely adhere to the original drug standards and the product quality is up to standard. Flexible supply, whether it's 100g research testing, kilogram level or even 100kg commercial production, we can provide you with stable supply and avoid the risk of stockout.

Quality Control

R&D Results

Packaging and Transportation

After-Sales Service

Qualification Certification

Exhibition

FAQ

Q1:Is the crystal form of Darolutamide API Powder stable across different batches?

A1:We strictly follow the original research standards, strictly control the key process steps, and ensure the consistency of the polycrystalline structure.

Q2:Which cells is Darolutamide ineffective on?

A2:Darolutamide has no effect on the activity of the tested AR negative cell lines, DU-145 prostate cancer cells, and H1581 lung cancer cells.

Q3:Is Darolutamide a chemotherapy medicine?

A3:No, darolutamide is not chemotherapy. It is a type of targeted hormone therapy product.

Contact US

Are you intrested in Darolutamide API Powder?  You can send inquiry to sales1@faithfulbio.com.