The US FDA conducted a good manufacturing practices (GMP) inspection of Piramal Pharma's Bethlehem facility from 18 September 2023 to 27 September 2023.

On conclusion of the inspection, a Form-483 was issued with 2 observations. Both observations relate to system improvement only, and none are related to data integrity, said the firm.

The company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines, it added.

“The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations,” Piramal Pharma stated.

Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products.

The company reported a net loss of Rs 98.58 crore in Q1 FY24 as compared with net loss of Rs 109.05 crore in Q1 FY23. Net sales jumped 18% to Rs 1,748.85 crore during the quarter, up 18% as compared with Rs 1,481.99 crore in Q1 FY23.

Shares of Piramal Pharma declined 0.51% to Rs 97 on the BSE.