White Paper

Apalutamide API – an attractive NCE-1 opportunity for generic pharma companies

Prostate cancer accounts for 7.3% of all incident cases of cancer globally, as per estimates released by Globocan 2020. The 5-year prevalence of prostate cancer is estimated at ~ 5 million worldwide, making it the second most common cancer among men.

Apalutamide is an oral second-generation, nonsteroidal androgen receptor inhibitor and became the first FDA-approved drug for non-metastatic castration-resistant prostate cancer patients. It received additional approval in 2019 for metastatic hormone-sensitive prostate cancer and is in phase 3 trials for metastatic hormone-refractory prostate cancer.

Our API allows formulators to choose an IP-compliant market entry that meets the regulatory requirements. The key aspects of our offering are:

To continue reading our whitepaper, please fill in the contact form below

Explore other Whitepapers:

Know More

Email us: api@drreddys.com
+91 40 49002222

Download Now

Please fill the Contact form below in order to view the white paper

* I agree and accept the Privacy Policy and Terms of Use of this website.

Email us: api@drreddys.com | +91 40 49002222

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.

Let’s talk API sourcing live at

Tackle sourcing bottlenecks and compliance hurdles

Hall E1 Booth H28 24-26 June 2025, Shanghai

Book a Meeting