Dr. Reddys Portfolio of Anti-cancer APIs
We manufacture our Anti-cancer APIs at cGMP API manufacturing facilities which are successfully inspected by international regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA, and Health Canada.
Our team of process experts draws on their integrated understanding of IP, process development (API and formulation), and API manufacturing to ensure that by design, the process is lean, free from potential genotoxic impurities, and scalable to manufacture for early market entries. This is of particular importance to select the optimal synthesis route in the context of the IP situation. Other aspects are the solid-state forms and particle characteristics that are critical in formulation development.
We have incorporated sensitive and rigorous analytical methods to control the impurities at a specified level and extensively studied the flow properties, crystal size/shape, and morphology in accordance with future requirements. In addition, our APIs have been designed to address customized PSD requirements through size reduction and crystallization techniques, resulting in a high probability of successful formulation development.
