Dr. Reddy’s Laboratories is one the renowned pharmaceutical company in the Telugu states. Seems like there is a slight tension in the company now. As per the reports, DR Reddy’s Laboratories has received a warning letter in connection with the year 2015 in connection to Current Good Manufacturing Practice (CGMP) deviations in AP and Telangana besides oncology formulation facility at Duvvada, Visakhapatnam. Hence, people of the company might expect the inspection of its Active Pharmaceuticals Ingredients (API) plant at Srikakulam in Andhra Pradesh by the US Food and Drug Administration officials by the end of this year.
Co-Chairman, Managing Director and CEO GV Prasad told to the shareholders in a meeting as, “On the regulatory front, the API plant at Miryalaguda was given an Establishment Inspection Report (EIR) in 2017 resolving the earlier warning letter. We also received EIR for the injectable site at the Duvvada and we are awaiting for CTO VI site at Srikakulam. And based on discussions, we expect an inspection ( by the FDA) later this year and hopeful for the resolution of the matter”
On to this issue, the US FDA had earlier visited the DR Reddy’s in January this year and seems to be issued EIR again and will be re-visiting here.