Pharma major Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility in Gujarat following the closure of a product-specific pre-approval inspection conducted between March 2 and March 7, 2026.
The receipt of the EIR marks the successful conclusion of the US FDA inspection process for the facility and reinforces the company’s focus on maintaining global quality and compliance standards.
Focus on quality excellence
Commenting on the development, Lupin Managing Director Nilesh Gupta said the company remains committed to delivering safe and effective medicines to patients worldwide.
“We are pleased to receive the EIR from the US FDA for our Ankleshwar facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide,” he said.
Strong global footprint
Lupin is a global pharmaceutical company headquartered in Mumbai with products distributed across more than 100 markets worldwide. The company specialises in branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients (APIs).
The pharma major has built a strong presence in India and the US across multiple therapeutic segments including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system and women’s health.
Lupin currently operates 15 manufacturing facilities and seven research centres globally, supported by a workforce of over 24,000 employees.