Indian pharmaceutical major Dr. Reddy’s Laboratories is focused on remediation and risk mitigation measures after it received a warning letter pertaining to three of its facilities from U.S. Food and Drug Administration.
There is “high focus on remediation and risk mitigation measures,” Dr.Reddy’s CFO Saumen Chakraborty declared, while COO Abhijit Mukherjee highlighted the eagerness to comply notwithstanding the costs involved. The warning letter, Mr.Mukherjee added, is bound to have a reasonable impact though the company in interaction with customers did not find them expressing “large apprehensions.” Subsequent to giving its response to the letter, Dr.Reddy’s had also provided an update to the FDA in January.
Requisitioning a third-party consultant and undertaking statistical analysis of the distributed products are among steps the company has initiated since the regulator’s November letter pointed to deviations from current Good Manufacturing Practices at its API manufacturing facilities in Srikakulam, Andhra Pradesh and Miryalguda in Telangana as well as violation at the oncology formulation manufacturing facility at Duvvada (AP).
The senior executives were addressing the press here on Tuesday about third quarter results of Dr.Reddy’s which was impacted by the challenges in the emerging marketsand issues concerning repatriation from Venezuela in the backdrop of fall in oil prices.
During the quarter ended December 31, Dr.Reddy’s posted consolidated net profit of Rs.579.20 crore compared to the Rs.574.50 crore in the year ago period. Revenue rose by a little over three per cent to Rs.3,967.9 crore (Rs.3,843.1 crore).
