"The audit of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 8 observations, which we are addressing," the company said in a filing.
As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Dr. Reddy’s had outperformed the market in the past four trading days post-September quarter (Q2FY19) results, by gaining 8.5%, as compared to a 0.6% rise in the S&P BSE Sensex. Post results, most of the brokerage houses were bullish on the stock with a 12-month target price in the range of Rs 2,700 to Rs 2,850.
The fresh round of concerns raised by the USFDA inspectors over the Oncology formulations facility comes as a big set back to the company.
At 10:00 am; Dr. Reddy’s was trading 5% lower at Rs 2,464 on the BSE, as compared to 0.66% decline in the benchmark index. A combined 675,955 equity shares changed hands on the counter on the BSE and NSE so far.
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