Piramal Pharma gets EIR for Lexington facility from US FDA

In a regulatory filing made in December last year, the company said that the United States Food and Drug Administration (US FDA) conducted a general good manufacturing practices (GMP) inspection of Piramal Pharma?s Lexington (Kentucky, USA) facility from 03 December 2025 to 10 December 2025.

At the conclusion of the inspection, the US FDA issued a Form-483, with four observations.

These observations are related to enhancement in procedures and will be classified as a VAI (voluntary action indicated). The company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines,? Piramal Pharma had said in a statement.

Offering updates on the same, Piramal Pharma today (13 April 2026) said that the US FDA has issued an establishment inspection report (EIR) for the said manufacturing facility with VAI (voluntary action indicated).

Receipt of said EIR marks successful closure of the inspection, the company stated.

Piramal Pharma offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

The company a consolidated net loss of Rs 136.19 crore in the quarter ended December 2025 as against net profit of Rs 3.68 crore during the previous quarter ended December 2024. Sales declined 2.92% to Rs 2,139.87 crore in Q3 FY26 as compared with Q3 FY25.

The scrip rose 0.68% to currently trade at Rs 147.10 on the BSE.