Dr Reddys Shares Fall As US FDA Makes 13 Observations

Business

oi-Sunil Fernandes

Shares in Dr Reddys Fell after the US FDA issued Form-483 with 13 observations for the Visakhapatnam plant.

By Sunil Fernandes

Published: Thursday, March 9, 2017, 10:06 [IST]

Shares in Dr Reddys Fell after the US FDA issued Form-483 with 13 observations for the company's Visakhapatnam plant.

"The audit of our formulation manufacturing plant at Duvvada, Visakhapatnam, by the USFDA, has been completed today (8 March, 2017). We have been issued a Form-483 with 13 observations, which we are addressing," the company said.

The US FDA issues a Form-483 if finds any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws. This also means that the company cannot file for future product findings, unless the issues are rectified.

Indian pharma companies have increasingly begun being in the spotlight with some getting observations, while others get warning letters and some have already received import alert bans.

The new US administration under US President Donald Trump has also been determined to reduce drug costs in the country.

Check stock quote of Dr Reddys here