Dr Reddy's hits 52-week low on USFDA observations at Duvvada unit

The stock has fallen to its 52-week low of Rs 2,751, down 3.5% on BSE in early morning trade.

Dr Reddy's Laboratories has fallen to its 52-week low of Rs 2,751, down 3.5% on BSE in early morning trade after the US Food and Drug Administration (FDA) made 13 observations at the company’s formulations facility at Duvvada in Visakhapatnam.

“The audit of our formulation manufacturing facility at Duvvada, Visakhapatnam, by the USFDA, has been completed today. We have been issued a Form-483 with 13 observations, which we are addressing,” the company intimated the stock exchanges on March 8, 2017.

The FDA issues a Form-483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.

“The site manufactures cytoxic and hormonal injectable and is an important plant given Dr Reddy’s focus on complex generic filling. Since the US contributes nearly half of the company’s sales this could hit the incremental business impacting the near term profitability,” Angel Broking said in a client note.

At 09:25 am; the stock was down 2.8% at Rs 2,772 on BSE as compared to 0.14% decline in the S&P BSE Sensex. A combined 302,556 shares changed hands on the counter on BSE and NSE so far.