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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 on this website, 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, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.

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Dr. Reddy’s Laboratories, 8-2-337,
Banjara Hills Rd Number 3,
SBI Executive Enclave, Green Valley,
Banjara Hills, Hyderabad,
Telangana 500034
Phone: 040 4900 2222

© 2025 Dr. Reddy’s Laboratories Ltd. All rights reserved.

Dr. Reddy’s Laboratories, 8-2-337,
Banjara Hills Rd Number 3,
SBI Executive Enclave, Green Valley,
Banjara Hills, Hyderabad,
Telangana 500034
Phone: 040 4900 2222

  • Twitter

© 2025 Dr. Reddy’s Laboratories Ltd.
All rights reserved.

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