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White Paper

Tech Sheet on Enzalutamide Premix

Tech Sheet on Enzalutamide Premix

Chemical Name:

4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N- methylbenzamide.

Dr. Reddy's API Offerings*:

  • Innovator has filed an Enzalutamide premix amorphous form manufactured through spray drying, which uses API and HPMCAS as excipients. We offer an Enzalutamide premix amorphous form with a non- infringing process and composition.
  • Dr. Reddy's has a dedicated new manufacturing facility that offers Enzalutamide premix.
  • Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Enzalutamide API.
  • Besides USDMF, country-specific regulatory filings are necessary for global market expansion, so we have diversified our filling to all the major regulated markets.

To learn more, download the Tech sheet on Enzalutamide Premix API HERE.

Should you have any specific queries? I would be happy to schedule a meeting at your earliest convenience.

*Note: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

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No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.



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