Piramal Pharma Ltd on Tuesday (February 27) said its step-down wholly owned subsidiary, Piramal Critical Care B.V. (PCC BV), has been fined €1,82,001 by the Audiencia Nacional, Spain.
"...we hereby inform you regarding a fine of Euros 182,001 imposed on Piramal Critical Care B.V. (‘PCC BV’), a step-down wholly owned subsidiary of the Company by the Audiencia Nacional, Spain on 26th February 2024 (‘Audiencia’)," Piramal Pharma said in a regulatory filing.
The fine was imposed for non-supply of a product in Spain during a brief period from May 22, 2019, to June 18, 2019. This period coincided with the transfer of the Marketing Authorization in Spain from Janssen Pharma S.L. to PCC BV on May 22, 2019.
The sanction, issued by the Spanish Agency of Medicines and Medical Devices (AEMPS) in April 2021, was not based on technical or quality reasons but rather on the alleged insufficient supply of stock to the market.
"PCC BV received a sanction letter in April 2021 from the Spanish Agency of Medicines and Medical Devices (‘AEMPS’) for non-supply of a product in Spain for a brief period from 22nd May 2019 till 18th June 2019, which coincided with the transfer of the Marketing Authorization in Spain from Janssen Pharma S.L. to PCC BV (i.e. 22nd May 2019)," the pharma company said.
Upon appeal by PCC BV, the Audiencia, the appellate judicial body, upheld the fine of €1,82,001, inclusive of court fees. PCC BV is considering filing an appeal against the Audiencia's judgment before the Supreme Court in Spain.
The fine does not have any material impact on the financials, operations, or other activities of Piramal Pharma.
"PCC BV is contemplating filing an appeal against the Audiencia’s judgment before the Supreme Court in Spain. The fine levied on PCC BV does not have any material impact on financials, operation or other activities of the Company," the company added.
Shares of Piramal Pharma Ltd ended at ₹136.95, down by ₹1.00, or 0.74% on the BSE.
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