Piramal Pharma's US Facility Receives 3 FDA Observations

Piramal Pharma said the US Food and Drug Administration (USFDA) have conducted the pre-approval test (PAI) at its Riverview facility in the US.

USFDA inspected from January 29 to February 6, 2024. As a result of the inspection, Form-483, three observations were issued. Observations were classified as Voluntary Activity (VAI) and unrelated to data integrity.

The Company is preparing a detailed response to the above findings, which will be submitted to the US FDA within the established deadlines.

Piramal Pharma (PPL) offers a diversified portfolio of products and services through end-to-end manufacturing capabilities through 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract structure and manufacturing organization. Piramal Critical Care (PCC) is a multi-hospital business that has an Indian consumer healthcare division that sells over-the-counter medicines.

The Company reported a consolidated net profit of Rs 10,110 crore in 3Q FY24 compared to a net loss of Rs 90,180 crore in 3Q FY23. Operating profit for the quarter stood at Rs 1,958,570 crore, up 14.14% year-on-year.

Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization (CDMO) that provides end-to-end development and manufacturing solutions across the drug life cycle. They serve customers through a global network of facilities in North America, Europe and Asia. This enables us to offer various services, including pharmaceutical products, drug development activities and services, clinical trial equipment, commercial supply of APIs, and finished dosage forms.