Lupin receives favorable FDA inspection report for Pithampur Unit-3

Lupin Limited has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Pithampur Unit-3 facility, following an inspection conducted from July 7 to July 17, 2025. This report signifies a positive outcome from the regulatory assessment.

The Pithampur Unit-3 facility manufactures metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. managing director Nilesh Gupta stated that receiving the EIR underscores Lupin's commitment to maintaining high standards of compliance and quality.

The positive EIR reflects Lupin's continued adherence to regulatory requirements for its manufacturing operations as it aims to deliver high-quality, affordable medicines globally.