Piramal Pharma Limited, a leading pharmaceutical company, disclosed today that the United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) at its Lexington facility in the USA from February 20th to February 23rd, 2024. The inspection was conducted in relation to one of the products expected to be manufactured at this facility.
Following the conclusion of the inspection, the US FDA issued a Form-483 with 2 observations. It is important to note that these observations do not pose any risk to the site’s compliance standards or its business continuity.
In response to the observations, Piramal Pharma Limited is diligently preparing a detailed response which will be submitted to the US FDA within the stipulated timelines. The company reassures stakeholders that it remains steadfast in its commitment to maintaining the highest standards of compliance. Piramal Pharma Limited also affirmed its dedication to working closely with regulatory agencies to comprehensively address all observations.
This disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, serves to inform stakeholders and ensures transparency in Piramal Pharma Limited’s operations.
Disclaimer: This article is based on the disclosure made by Piramal Pharma Limited to the stock exchanges in India. Readers are encouraged to refer to official sources for further information and updates.