 "Timely closure of remedial actions our priority: Dr Reddy's")
Last year the USFDA had issued a warning letter to the company after making a set of critical observations over the gaps in quality protocols and practices noticed in three of the company's manufacturing facilities, including a formulation unit at Visakhapatnam in Andhra Pradesh.
The other two were the active pharmaceutical ingredient (API) facilities, located in AP and Telangana respectively.
"We have submitted our replies to the warning letter on December, 7, 2015, and we have also given the fist update on the remedial measures in the last week of January 2016," Dr Reddy's chief operating officer Abhijit Mukherjee said in a press conference.
Mukherjee added that they may also consider requesting the US drug regulator for an audit of the three facilities after giving periodical updates in the near future. Responding to a question he said they have not received any response from the USFDA on their submissions as that was not a usual practice.
According to Saumen Chakraborty, chief financial officer, the company would give high priority and focus on the remedial actions. "We focus on timely closure of all remedial actions and risk mitigation measures," he said indicating the company's intent for a quick resolution to the regulatory issues.
When asked if the financial impact arising out of the warning letter was in line with the earlier expectations, Mukherjee said the delay in the launch of blockbuster Nexium itself would cost a notional revenue loss equal to the earlier projected impact of $50-60 million on revenues.
The launch of one more product was also impacted as the approval came from one of the three sites and the loss coming out of this delay would be even larger, according to him.
