Natco Pharma’s Chennai API Unit Receives US FDA EIR with Voluntary Action Indicated

Natco Pharma Limited announced that its Chennai API manufacturing facility has successfully concluded a US FDA inspection, receiving an Establishment Inspection Report (EIR) marked as Voluntary Action Indicated (VAI). The inspection, held between November 17–21, 2025, resulted in seven Form 483 observations.

The company clarified that the observations are procedural, not product-related, and assured stakeholders of comprehensive corrective actions. Natco reaffirmed its commitment to current Good Manufacturing Practices (cGMP) and emphasized its focus on maintaining high-quality standards across global markets.

This development is significant as a VAI classification indicates that while improvements are required, the facility remains compliant and can continue operations without regulatory restrictions.

Key Highlights

• Inspection Outcome: US FDA issued EIR with Voluntary Action Indicated.
• Observations: Seven procedural findings under Form 483.
• Facility: API unit located in Manali, Chennai.
• Company Response: Natco confident of addressing all observations.
• Compliance Assurance: Commitment to cGMP and global quality standards.

Natco’s proactive stance on compliance strengthens its credibility in the pharmaceutical sector, ensuring uninterrupted supply of APIs to international markets.

Sources: Economic Times Pharma, Business Upturn, FilingReader Intelligence