Drug major Dr Reddy's Laboratories Ltd informed the stock exchanges today that the US Food and Drug Administration (US FDA) has issued the Establishment Inspection Report (EIR) for its Active Pharmaceutical Ingredients (API) manufacturing facility at Srikakulam indicating closure of the audit.
This facility is one of the company's three manufacturing plants that were served a warning letter by the US FDA in November 2015 for not following the prescribed operational and manufacturing quality standards.
The two other units-- Duvvada formulation plant in Andhra Pradesh and Miryalaguda API plant in Telangana, had already been cleared by the US drug regulator a few years ago after multiple audits.
The five-year overhang of the warning letter has come to an end for the company with the receipt of EIR for the third facility, which was subjected to the last audit in January.
Besides facing the import restrictions, the company had been denied new product approvals from these three facilities under the warning letter, impacting Dr Reddy's revenue growth in the US market in the past.
The stock price of Dr Reddy's rose as high as 7 percent to Rs 4099.90 from the previous close of Rs 3,834.35 on Bombay Stock Exchange at the opening trade on Friday.