Natco Pharma’s Vizag FDF unit gets 4 U.S. FDA observations
Natco Pharma received four observations from the U.S. FDA following an inspection of its Visakhapatnam manufacturing facility. The company stated that the observations are procedural and expects to resolve them within the required timeframe.
Why it matters
Regulatory compliance with the U.S. FDA is essential for Indian pharmaceutical companies to maintain their export market access.
The U.S. Food and Drug Administration (U.S. FDA) has issued a Form 483 with four observations to Natco Pharma after inspecting the generic drugmaker’s finished dosage formulations (FDF) unit in Visakhapatnam.
The U.S. FDA had conducted the inspection from August 17-21. Natco Pharma said it believes the observations are procedural in nature and is confident of addressing them comprehensively within stipulated timelines.
business (general) / pharmaceutical / medicine
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