The company said the inspection concluded with a Voluntary Action Indicated (VAI) status, indicating that while certain observations may have been noted, no immediate regulatory action is required.
The development follows the USFDA inspection conducted at the Lexington facility in December 2025, Piramal Pharma said in an exchange filing.
Receipt of the EIR signifies that the inspection process has been formally closed, the company added.
The Lexington facility is part of Piramal Pharma’s global manufacturing network, which serves regulated markets, including the United States.
In January this year, Piramal Pharma revealed a positive long-term outlook, saying it continues to believe in the growth potential of its businesses and remains committed to supporting this through timely investments in capacity and capabilities.
While the company posted weak December quarter numbers, it noted that the March quarter has historically been its strongest and expects this trend to continue in the current financial year as well.
Following the USFDA announcement, shares of Piramal Pharma Ltd were trading 0.63% up at ₹146.90 as of 10.58 am. The stock has gained over 5% in the last month, while delivering a negative 34% return over the last 12 months.
