Strides Puducherry Facility Classified by USFDA as Official Action Initiated (OAI)
Posted on May 7, 2019
The Company has received a communication from the USFDA on 4th May 2019 classifying the facility as Official Action Initiated (OAI) based on the inspection conducted from 28th January – 5th February 2019.
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. However, of the 34 ANDA’s pending approval, Puducherry has 10 ANDA’s where the Company expects delays until the facility is reclassified.
The Company will provide more updates during its Q4 FY 19 earnings call scheduled for 10th May 2019.
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