Strides Pharma shares down by 5% over US FDA's stern action

Last Updated: Tue, May 07, 2019 00:42 hrs
USFDA

Shares of Strides Pharma ended the trading session on Monday down by 5.25% or 25.30 points at Rs 457 per share.

The company in a filing announced that it received a stern message from US health regulator- US FDA.

The company said that the US health regulator had classified its Puducherry facility as official action initiated (OAI) for non-compliance of norms following an inspection.

The US Food and Drug Administration (USFDA) inspected the Puducherry facility and classified the facility as an "OAI" on May 4, 2019 based on its inspection. This inspection was conducted from January 28 to February 5, 2019.

OAI refers to regulatory and / or administrative actions recommended for facility which was inspected after the USFDA determines if the areas evaluated were in compliance with applicable laws and regulations.

"While the company is disappointed with the outcome of the inspection, the company believes that the classification will not have an impact on the current supplies and revenues from the facility," Strides Pharma Sciences said.

The company said of the 34 ANDA's (abbreviated new drug application) pending approval, Puducherry has 10 ANDA's where the company expects delays until the facility is reclassified.