Lupin Limited has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar facility in Gujarat, Lupin announced on May 28, 2026.
The EIR follows the closure of a product-specific Pre-Approval Inspection conducted at the Ankleshwar site from March 2 to March 7, 2026. Receipt of the EIR confirms the facility has met US FDA requirements. This resolves the regulatory status of the Ankleshwar facility, which manufactures pharmaceutical products for the US market.
Lupin is a global pharmaceutical company headquartered in Mumbai, India. Lupin distributes products across over 100 markets worldwide. Lupin's portfolio includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin is among the leading pharmaceutical companies in India with a significant position in the US generics market.
Lupin operates across multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 manufacturing sites and 7 research centers globally. Lupin's manufacturing network spans sites across India and other locations.
Lupin employs over 24,000 professionals. Lupin's subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. The clearance of the Ankleshwar facility by the US FDA removes regulatory uncertainty for this key Lupin manufacturing site supplying the US market.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.