The USFDA warns Aurobindo of actions against Unit VII
Hyderabad: Pharma, the big city-based pharmacist, said Thursday that the US drug control agency. UU., The US Food and Drug Administration. UU. (USFDA) warned that it can initiate regulatory actions against its manufacturing plant for oral solid formulations, Unit VII, in Telangana.
The company said the USFDA wrote to the company saying that its inspection of the unit, located on the outskirts of the city in the Medak district, has been classified as an Official Indicated Action (OAI). According to the USFDA website, OAI means that regulatory and/or administrative actions will be recommended.
In addition to our indications of October 7 and 11, 2019 regarding the inspection of Unit VII of the USFDA, a manufacturing facility for oral solid formulation of the company, we inform you that the company has received a letter from the USFDA that classifies the inspection performed at the facility mentioned as Official Indicated Action (OAI), ”said Aurobindo Pharma in a regulatory presentation to the resources.
The company said the OAI classification is not expected to have any impact on revenue. The company believes that this OAI classification will not have any material impact on existing revenues or supplies for our business in the United States at this time, the company said in the presentation,
Aurobindo Pharma also said it will work closely with the regulator to address the issues in a comprehensive manner.
The news of the OAI classification for Unit VII sent a company scrip that fell 8% to a minimum of Rs 466.75 before closing 5.32% below Rs 480.30 compared to Wednesday's closing price of Rs 507.30 per action