Lupin’s Goa Facility Receives US FDA EIR, Reinforcing Compliance Standards

Mumbai-based Lupin Limited announced that its Goa manufacturing plant has successfully received the Establishment Inspection Report (EIR) from the US FDA. This follows a detailed inspection carried out in September 2021. The facility’s classification as Voluntary Action Indicated (VAI) reflects Lupin’s commitment to quality, compliance, and global regulatory standards.

Key Highlights

• Inspection Outcome: US FDA issued an EIR for Lupin’s Goa facility.
• Classification: The plant was categorized under Voluntary Action Indicated (VAI).
• Significance: Reinforces Lupin’s reputation for quality and compliance in pharmaceutical manufacturing.
• Leadership Statement: Lupin’s management emphasized that this milestone strengthens confidence in its global supply chain and regulatory adherence.
• Strategic Impact: The clearance paves the way for smoother product approvals and exports to the US market.

This development is crucial for Lupin as it continues to expand its footprint in regulated markets, ensuring that its manufacturing facilities meet the highest standards of safety and quality.

Sources: Lupin Official Announcement, Manufacturing Today India, PharmaTutor