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Lupin’s Ankleshwar Facility Receives EIR from U.S. FDA

Mumbai, May 28, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar facility in Gujarat, India, following closure of a product-specific Pre-Approval Inspection from March 2 to March 7, 2026.

Nilesh Gupta, Managing Director, Lupin, stated, "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,"

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn.

For further information or queries, please contact:

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

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