Dr Reddy's Laboratories Limited shares tumbled in early trades, with investors reacting to a disclosure by the company that it has received a Form 483 with 2 observations from the US Food and Drug Administration for its active pharmaceutical ingredients plant at Srikakulam in Andhra Pradesh.
Dr Reddy's Laboratories said that the USFDA completed the audit at the company's API Manufacturng plant at Srikakulam on Tuesday and issued a Form 483 with 2 observations.
The unit at Srikakulam had already received a warning letter from the US drug regulator in November 2015. The present Form 483 issuance is following the re-inspection at the unit after Dr Reddy's Laboratories took some corrective steps.
Two other units of the drugmaker too received warning letters in late 2015. While all the three units received the Form 483 with observations requiring further remediation related to the specific observations during the just concluded re-inspection process, Srikakulam unit received the least number of observations compared to 13 observations, including some repeat observations cited in the warning letter by its oncology formulations unit at Duvvada in Visakhapatnam of AP, and 3 observations by its Miryalaguda plant in Telangana.
Dr Reddy's Laboratories declined to Rs 2678.80 in early trades, losing about 2.5% in the process, but has recovered to Rs 2730 now, down just 0.6% from its previous closing price.
