The US Food and Drug Administration has issued an establishment inspection report for Aurobindo Pharma subsidiary Eugia Pharma's injectable facility in Telangana, classifying it as Voluntary Action Indicated (VAI) on June 27.
The US drug regulator inspected the said facility from February 19-29, 2024.
A VAI classification means that the US FDA has found some lapses during its inspection, but these issues are not severe enough to require immediate enforcement action. The company is therefore expected to voluntarily correct these issues to comply with regulatory standards.
Meanwhile, shares of Aurobindo Pharma hit the day's low following the news of the VAI classification. At 12.44 pm, shares of Aurobindo Pharma were trading one percent lower at Rs 1,185.75 on the NSE.
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Earlier this year, the US FDA had also slapped nine observations for another Telangana manufacturing unit of Eugia Pharma, situated in the Sangareddy district. In recent times, several of Aurobindo Pharma's manufacturing units have been entangled in regulatory hurdles.
Regardless, Aurobindo Pharma is also looking to unlock value by exploring a big-bang initial public offer (IPO) of its wholly-owned subsidiary — speciality generic firm Eugia Pharma to raise around Rs 4,500 crore in 2024.
Aurobindo Pharma also stated in an exchange filing last year that it was in the process of exploring all possibilities for restructuring the business of Eugia Pharma.
Eugia Pharma operates six manufacturing units across various locations in India and the US. These units produce a wide range of unique and differentiated products, including general injectables, oncology treatments, hormonal therapies, penems, penicillin, and ophthalmics. According to the company's website, Eugia Pharma is present in over 120 countries, employs more than 4,000 people, and has over 250 globally approved generics.
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