Dr Reddy’s gets US FDA nod for Srikakulam plant in Andhra Pradesh

NEW DELHI: Dr Reddy’s Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration (FDA) for its facility at Srikakulam in Andhra Pradesh, and that the regulator has classified all its observations of violations at the plant as voluntary action indicated (VAI).

A VAI classification indicates that the US FDA does not consider the violations as serious enough to warrant a mandatory action from the company.

“With this, all facilities under warning letter are now determined as VAl,” Dr Reddy’s said in an exchange filing, in the establishment inspection report (EIR).

In November 2015, the US FDA had issued a joint warning letter to three of the company’s facilities at Srikakulam and Duvvada in Andhra Pradesh and Miryalguda in Telangana. In the letter, the regulator had observed issues with quality of raw material and product batches, failure of staff to provide adequate controls to prevent omission of data, and inability to maintain all quality-related documents, among others.

Last month, the company had informed that it had received an EIR for its Miryalguda plant with all the observations classified as VAI, while the Duvvada plant’s observations were classified as VAI in February.

News of the clearance through the EIR lifted Dr Reddy’s shares by nearly 4% to ₹3975.00 on the BSE, while the broader Sensex traded up 1.6% to 31,956.15.