Piramal Pharma gets 4 US FDA observations at Lexington facility

• Piramal Pharma received four observations from the US FDA.
• The observations followed a routine Good Manufacturing Practices (GMP) inspection at its Lexington, Kentucky facility.
• The inspection occurred between December 3 and December 10, 2025.
• Piramal Pharma expects the observations to be classified as VAI, not requiring mandatory regulatory action.
• The company is preparing a detailed response to the US FDA.

Why It Matters: Piramal Pharma's US FDA observations highlight continuous regulatory oversight.