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Aurobindo Pharma Subsidiary’s Telangana Units Gets VAI Status from USFDA 

The EIR relates to Aurobindo Pharma's new injectable manufacturing facility in Parawada Mandal.

Aurobindo Pharma subsidiary Eugia Pharma’s injectable plant in Telangana was classified by the US Food and Drug Administration (USFDA) in an establishment inspection report as a voluntary action indicated (VAI) facility.

The US regulator conducted an inspection at Eugia Pharma’s unit in Telangana from 19 February to 29 February 2024.

Although several faults were found by the US FDA during its inspection, a VAI classification means that the errors were not significant enough to warrant immediate enforcement action. Therefore, the company is required to voluntarily address these issues in order to meet regulatory requirements.

Earlier this year, the US FDA also sent nine warning letters to a second Eugia Pharma production facility in the Sangareddy, Telangana, area. Aurobindo Pharma’s manufacturing facilities have encountered several regulatory obstacles lately.

However, Aurobindo Pharma is also considering a big-bang initial public offering (IPO) of its wholly-owned subsidiary, specialty generic producer Eugia Pharma, with the aim to raise approximately Rs 4,500 crore by 2024, in an effort to unlock value.

In an exchange filing from the previous year, Aurobindo Pharma also mentioned that it was investigating all options for reorganising Eugia Pharma’s operations.

Eugia Pharma runs six production facilities in various parts of the US and India. These units manufacture penems, penicillin, ophthalmics, hormone therapies, oncology treatments, and general injectables, among the many distinctive and differentiable items. On its website, Eugia Pharma claims to have over 250 globally authorised generics, be present in over 120 countries, and employ over 4,000 people.

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