Drug firm Piramal Pharma Ltd on Thursday (September 28) said the company has successfully concluded the Good Manufacturing Practices (GMP) inspection conducted by the United States Food and Drug Administration (USFDA).
The inspection, which took place from September 18-27, was focused on Piramal Pharma's manufacturing facility located in Bethlehem, USA.
Upon completion of the inspection, the USFDA issued a Form-483 with two observations. Importantly, both observations pertain solely to system improvements and do not raise any concerns related to data integrity.
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Piramal Pharma is diligently preparing a comprehensive response to address these observations, ensuring full compliance with regulatory standards. The response will be submitted to the USFDA within the stipulated timelines.
Shares of Piramal Pharma Ltd ended at Rs 97.50, up by Rs 0.65, or 0.67 percent, on the BSE.
