The USFDA has completed the inspection of Dr. Reddy’s facilities in Srikakulam, Andhra Pradesh without making any observations.
The USFDA audit has been conducted at its active pharmaceutical ingredient (API) Srikakulam special economic zone plant, from April 10-14.
The API SEZ plant is a fully automated new generation plant catering to the US market. A Warning letter has not been issued to this facility and is up for a routine USFDA audit.
The facility has been used for filing new products and is also earmarked for transferring manufacturing of certain existing products.