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Pharma major Dr Reddy’s Laboratories Ltd is `extremely disappointed’ over warning letters from the USFDA on three of its facilities.
``Right from our very first audit for Methyldopa way back in October 1987 and through the three decades hence, when we underwent more than 50 audits, we have always committed ourselves to maintaining higher standards… As such we are extremely disappointed when we received warning letters,’’ its Chairman K Satish Reddy said while addressing shareholders at the 32{+n}{+d} annual general meeting of the company held here.
The company has responded to the letters in detail within stipulated timelines, he added.
While stating that the company will tide over the challenge, Reddy said it was important for India to address quality and regulatory issues at an industry-body level.
“As such it can only be advantageous for companies to work together in a consistent manner to address these issues and find sustainable solutions,’’ he added.
In November last year, USFDA had issued warning letters on two facilities making active pharmaceutical ingredients (APIs) at Srikakulam (Andhra Pradesh) and Miryalaguda (Telangana), and a cancer products manufacturing facility at Duvvada Visakhapatnam (AP). The remediation cost incurred by the company on account of these letters was cited as one of the reasons for an 80 per cent slump in Dr Reddy’s net in the first quarter ended June 30, 2016. It decreased to Rs 126 crore from Rs 626 crore in the year-ago period.
Dr Reddy’s scrip gained marginally on the Bombay Stock Exchange on Friday and is trading at Rs 2967.65.
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