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About Apalutamide (Amorphous & Form B) API

Product
  • Therapeutic CategoryAnti-Cancer/ Oncology

  • CAS Number

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    Brazil DMF, USDMF

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Related Resources

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

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