Apalutamide API

Apalutamide API

CAS No.956104-40-8
Therapeutic CategoryAnti-Cancer/Oncology
Dosage FormOral Solids
Innovator BrandErleada(USA)
Registration StatusDMF
PolymorphForm   B;   New form  with  own patent
GMPFDA(USA)/NMPA(China)/MFDS  (Korea)  approved
EHSISO 14001 &45001 certificated

Product Description

  • Grade:  Active Pharmaceutical Ingredient(API)
  • Chemical name: 4-[7-[6-cyano-5-(trifluoromethyl)pyrid in-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide
  • Molecular Formula: C21H15F4N5O2S
  • Molecular Weight: 477.43g/mol
  • Specification: Enterprise Standard established according to ChP/USP/EP
  • Appearance: White to light yellow powder
  • Total impurities: not more than 0.5%
  • Purity: not less than 99%
  • Residual Solvents: fully comply with ICH Q3C
  • Mutagenic impurities: fully comply with ICH M8
  • Nitrosamine assessment: available
  • Particle size: regular grade or milling/sieving according to customer’s requirement.
  • Storage: Room temperature
  • Production capacity: Commercial
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Apalutamide

  • Apalutamide is a potent androgen receptor (AR) antagonist that selectively binds to the ligand-binding domain of AR and blocks AR nuclear translocation or binding to androgen response elements. It has been used in trials studying the treatment of Prostate Cancer, Hepatic Impairment, Prostatic Neoplasms, Castration-Resistant Prostate Cancer, and Prostatic Neoplasms, Castration-Resistant, among others.
  • Exerting an antitumor action, Apalutamide blocks the effect of androgens that promote tumor growth. It targets the AR ligand-binding domain and prevents AR nuclear translocation, DNA binding, and transcription of AR gene targets in prostate tumors.
  • In mice bearing human CRPC xenograft models, Apalutamide treatment produced tumor regressions in a dose-dependent manner that was more effective than that of Bicalutamide or Enzalutamide. Unlike bicalutamide, Apalutamide antagonized AR-mediated signaling in AR overexpressing human CRPC cell lines.

Why Choose Us as Your Apalutamide Manufacturing Company?

  • Qingmu is an Apalutamide supplier, our Apalutamide has been filed in China(DMF filed and listed on CDE’s website), and DMF in CTD format is available and can be supported for registration worldwide.
  • Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. Our new API factory is under design and is predicted to be put into use in 2025. So please rest assured to choose us.
  • Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research. 
  • Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
  • As a China Apalutamide Manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.


A1: We are a manufacturer.

A2: Negotiate via email→ sign the contract →ship the goods

A3: We have GMP certificate issued by Chinese NMPA, EIR letter issued by USFDA, GMP certificate issued by Korean MFDS, CEP certificate, etc.

A4: Our factory is managed by GMP, we have our own QC lab to test the material and APIs.

A5: We have compliant SOP as per GMP requirement and will be handled according to SOP.