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US health regulator wants action against Strides Pharma's Puducherry unit

USFDA has classified the facility as OAI based on the inspection conducted from January 28 to February 5, 2019

Press Trust of India  |  New Delhi 

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Science Ltd Monday said the has classified its facility as official action initiated (OAI) for non-compliance of norms following an inspection.

The company has received a communication from the (USFDA) on May 4, 2019, classifying the facility as OAI based on the inspection conducted from January 28 to February 5, 2019, Science said in a regulatory filing.

According to the USFDA, an OAI means regulatory and/or administrative actions will be recommended for the facility which was inspected after it 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," Sciences said.

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

First Published: Mon, May 06 2019. 13:15 IST
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