USFDA concludes inspection of Dr Reddy's Miryalaguda facility

The US drug regulator US Food and Drug Administration (USFDA) has concluded the inspection of Dr Reddy's Miryalaguda manufacturing facility in Telangana. It's outcome was much awaited. The US FDA has made some observations which the company will have to address.

In a note to the Bombay Stock Exchange on Tuesday, February 21, Dr Reddy's informed that "the audit of the company's API manufacturing plant at Miryalaguda, by the US FDA, has been completed on February 21, 2017." But then, it also adds that the company has been "issued a Form 483 with three observations, which the company is addressing."

Analysts are not in a position to comment on what this could mean for the company as little is known about the exact nature of these observations. All eyes are now on how and how soon the company addresses these and also, going forward, the outcome of the inspections by the US FDA of  the company's two plants in Andhra  - one in Srikakulam and the other in Visakhapatnam.

Exports from these three units have been impacted following the warning letter issued by the US FDA in November 2015.