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Tech Sheet: Dr. Reddy’s Abiraterone Acetate API offerings

Abiraterone Acetate API

Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 selectively and irreversibly via a covalent binding mechanism. Abiraterone is a CYP17 inhibitor indicated in combination with prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) and Metastatic high-risk castration-sensitive prostate cancer (CSPC).

Abiraterone Acetate (Zytiga, Janssen Biotech Inc.) was approved by the Food and Drug Administration (FDA) on April 28, 2011, for Prostate Cancer treatment. In December 2012, FDA expanded Zytiga’s use for late-stage Prostate Cancer. In February 2018, the FDA approved Abiraterone Acetate tablets with prednisone for metastatic high-risk castration sensitive prostate cancer (CSPC).

As of February 2008, Abiraterone is approved in various countries worldwide for different indications.

Key takeaways of Dr. Reddy’s Abiraterone Acetate API:

  • Enough capacity to cater to current market requirements.
  • Quality – in line with ICH guidelines.
  • Earliest generic API manufacturer of abiraterone globally.
  • Country-specific regulatory filings
  • GTI & Nitrosamine free.

To know more about our offerings , please read the technical sheet on Abiraterone Acetate by filling the contact form below.

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Disclaimer

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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