Drug Approval | February 26, 2024
Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility
The observations do not pose any risk to site's compliance standards or its business continuity
The observations do not pose any risk to site's compliance standards or its business continuity
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company will submit its comprehensive response on these observations to the US FDA
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Company experts to participate in eight sessions covering AI-powered clinical development, regulatory innovation, oncology research, and patient engagement
This facility plays an important role in Granules’ global manufacturing and supply network
The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
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