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17+ years, with experience in NCE, NDDS, and generic formulation development. Kamalanathan is a noted inventor with multiple patents in the area of pharmaceutical formulation development. He is an expert in formulating development strategies for Parenteral dosage forms and selecting suitable dosage forms for FIH and subsequent clinical studies. Throughout his career, he has led a team of formulation, portfolio management, and business development to support pre-formulation, formulation development, scale-up, process characterization and technology transfer for multiple ANDA, NDAs, INDs for top global pharmaceutical organizations for regulated and semi-regulated markets. He has provided technical leadership for the successful development of multiple complex generics for NCEs (at various phases of development) and 505(b)(2)s
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