Lupin Receives US FDA EIR for Goa Facility with VAI Classification
Filing Summary
Lupin Limited has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility in Goa, India. The EIR, issued after an inspection conducted from November 10 to November 21, 2025, classifies the facility under a Voluntary Action Indicated (VAI) status. This classification indicates that the facility meets the necessary compliance requirements. Lupin, a global pharmaceutical company, continues to focus on regulatory compliance and quality excellence in its operations.
Lupin Limited has announced the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its facility located in Goa, India. The report follows an inspection conducted from November 10 to November 21, 2025, and classifies the facility with a Voluntary Action Indicated (VAI) status.
The VAI classification indicates that the facility is in compliance with the necessary regulatory requirements. This status suggests that while there may be some issues identified during the inspection, they do not warrant regulatory or enforcement action. The receipt of the EIR with a satisfactory classification is a significant regulatory milestone for the company.
The inspection and subsequent classification are part of the US FDA’s routine oversight of pharmaceutical manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP). The Goa facility is one of Lupin’s key manufacturing sites, contributing to its global supply chain.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India. The company specializes in the development and manufacturing of a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates in over 100 markets worldwide, with a strong presence in the United States and India across various therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin is committed to maintaining high standards of quality and regulatory compliance across its operations. The company operates 15 manufacturing sites and 7 research centers globally, employing over 24,000 professionals. Lupin continues to focus on improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.