Piramal Pharma’s Turbhe Facility Gets US FDA Observations

18 Feb 2025 , 11:02 PM

The United States Food and Drug Administration (US FDA) has conducted General Good Manufacturing Practice (GMP) inspection at Piramal Pharma Ltd’s plant at Turbhe in Navi Mumbai from February 11, 2025 to February 17, 2025.

This month, the US FDA inspected the facility and after inspection issued a Form 483 of six observations as the company has to improve compliance in this regard. The observations are mainly procedural and do not indicate any data integrity issues, Piramal Pharma added in a regulatory filing.

The company is preparing a detailed response to the comments which will be filed with the US FDA in the stipulated time period. Piramal Pharma reaffirmed it remains committed to best in class compliance and is confident of addressing the observations effectively.

On the financial side, it announced a 63.4% year-on-year (YoY) net profit decrease at ₹3.7 crore in Q3 FY25, compared to ₹10.1 crore in Q3 FY24. Despite the decline in net profit, income from operations was up11. 07% year-on-year (YoY) at ₹2,204.2 crore, as opposed to ₹1,958.6 crore in the year-ago quarter. Operating level operational performance denoted by EBITDA has been increased by 25.8% Y-o-Y at ₹337.7 crore in Q3 FY24 v/s ₹268.4 crore.