Piramal Pharma Ltd gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The US FDA conducted a Pre-Approval Inspection (PAI) inspection of Piramal Pharma Limited's Lexington (USA) facility from 20th February, 2024 to 23rd February, 2024 for one of the product expected to be manufactured at this facility.

On conclusion of the inspection, a Form-483 was issued with 2 observations. The observations does not pose any risk to site's compliance standards or its business continuity. The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines.

The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.

Shares of Piramal Pharma Limited was last trading in BSE at Rs. 136.30 as compared to the previous close of Rs. 134.55. The total number of shares traded during the day was 92617 in over 1167 trades.

The stock hit an intraday high of Rs. 137.30 and intraday low of 134.30. The net turnover during the day was Rs. 12585643.00.

Source : Equity Bulls

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PiramalPharma PPLPHARMA INE0DK501011 Pharmaceuticals PreApprovalInspection USFDA Form483 2Observations