Drug Approval | January 12, 2023
USFDA inspects Piramal Pharma Lexington facility
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
None of the observations are related to data integrity and management believes that they are addressable
The company will submit an action plan on the observations and will engage with US FDA for next steps.
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The CRL did not identify any outstanding scientific issues with the product.
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
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