In a major setback to drug major Dr Reddy's Laboratories, the company's Duvvada oncology formulation facility has received 13 observations from the US Food and Drug Administration, sending the shares down 4 percent to hit 31-month low on the BSE.
According to a report by CNBC-TV18, the unit had received a warning letter in November 2015 but the company had sought a reinspection after taking remedial measures. The letter had raised issues of batch failures, a probable microbial contamination and certain lapses in quality control procedures.
The company had first submitted response regarding the warning letter to the US FDA in December 2015 and gave final status update on the matter in August 2016.
The company had said the USFDA's reinspection was sechduled for January-March and expectation was that it would get a clean chit.
In November 2015, the company had received USFDA's warning letters over inadequate quality control procedures at its three drug manufacturing units in India - at Srikakulam, Miryalaguda and Duvvada. While the Miryalaguda unit had received three observations, the reinsepction two other facilities are coming up in April, a report by Moneycontrol said.
The Duvvuda unit makes cytotoxic and hormonal injectables. It is an important unit for Dr Reddy’s, said the report.
Published Date: Mar 09, 2017 11:54 am | Updated Date: Mar 09, 2017 12:56 pm