Piramal Pharma shares gained more than 4% on Thursday after the company announced that it has received an ‘Establishment Inspection Report’ (EIR) from the United States Food and Drug Administration (USFDA) for one of its manufacturing units located in Pennsylvania.
The inspection has been successfully closed by the FDA, and the US health and food regulator has issued an EIR to the said manufacturing facility, the company said in a filing with the stock exchanges.
Piramal Pharma had announced on September 28, 2023, that the USFDA conducted a Good Manufacturing Practices (GMP) inspection of the company’s Bethlehem facility from September 18 to September 27 and issued a Form 483 after the inspection.
The health regulator, while issuing Form 483, made two observations related to system improvement only. None of the observations were related to data integrity, the company said.
“The Company remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all observations,” Piramal Pharma said.
Piramal Pharma says @US_FDA issues establishment inspection report (EIR) for Bethlehem unit in the US, indicating closure of the inspection pic.twitter.com/NNLTEkJ7yC
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For the September quarter, Piramal Pharma reported an 11.13% growth in consolidated net sales at ₹1,911.38 crore on a year-on-year basis, compared to ₹1,720.01 crore in the same period last year.
Its earnings before interest, taxes, depreciation, and amortisation or EBITDA, witnessed a 43.9% rise on a YoY basis in the quarter under review at ₹314.83 crore as opposed to ₹218.78 crore in the year-ago period.
Shares of the company were trading 2.76% higher at ₹ 118.7 per piece on BSE at 12:57 PM.
(Edited by : Ajay Vaishnav)
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