Eugia gets USFDA warning letter for Unit-3 in Pashamylaram

Eugia Pharma, a wholly-owned subsidiary of Hyderabad-based Aurobindo Pharma received a warning letter from the USFDA. Eugia’s facility at Pashamylaram near Hyderabad was inspected between January 22 to February 2, 2024, after which serevral observations were issued. Subsequently, the company received Official Action Indicated (OAI) status in May 2024.

This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

There is no impact on the existing supplies to the US markets, however, the company will not receive approval for new products from Eugia Unit-3 until the issues are resolved.