Shilpa Medicare, a Rs.625 crore Hyderabad based pharma major, has received US FDA approval for azacitidine injection. The company is producing this injections from its SEZ formulations facility situated at Jadcherla, near Hyderabad.
The company incurred a R&D expenditure of Rs.34.07 crore during 2015-16. The activity in R&D centers includes chemical route evaluation keeping in mind the IPR protection, identification of key process parameters and optimization of processes, etc. As many as 11 oncology API’s and 4 non-oncology APIs have been developed in R&D and successfully transferred the technology to plant for commercial production. Another set of 18 new oncology drugs are currently under development.