Talking about the observations received recently from the US FDA, GV Prasad of Dr Reddy's Laboratories, in an interview with CNBC-TV18, said that the pharma company was continuously trying to improve its standards and practices.
“Duvvada plant has been cleared and it is a result of the major transformation in manufacturing and quality that we achieve over the last three years. of course, as I mentioned, quality is a journey and we have to keep at it and continue to improve our standards, practices and people competencies,” said Prasad.
The company recently informed the exchanges about its Formulations Manufacturing Plant - 3 at Bachupally, Hyderabad receiving a Form 483 with 11 observations by US FDA.
"Bachupally – we are in the process of responding to the FDA’s concerns and we are in advanced stages of drafting a response and providing the information that they need,” Prasad explained.
In terms of Srikakulam facility, Reddy said, “That facility is still not yet cleared but we are addressing the concerns of the FDA. The FDA has a series of questions which we are answering.”