Piramal Pharma facility gets six U.S. FDA observations

Piramal Pharma’s facility in Turbhe, Navi Mumbai, has received six observations after a U.S. Food and Drug Administration inspection.

A Form-483 with six observations was issued by the U.S. FDA after the General GMP inspection of the facility from February 11-17. The observations are largely around improvement of procedures and practices and not related to data integrity. The company is preparing a detailed response, which will be submitted to agency within stipulated timelines, Piramal Pharma said in a filing on Tuesday (February 18, 2025).

The Turbhe facility offers expertise in development and commercial manufacturing of both solution phase and solid phase synthesis of peptides, according to the company’s website. It also offers a portfolio of generic peptide APIs from multigram to kilogram scale. Piramal Pharma shares closed 1.58% lower on BSE at ₹196.70 each.