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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: 

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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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