Lupin’s Pithampur Unit-3 Receives FDA Inspection Clearance

Lupin Limited has received an Establishment Inspection Report (EIR) from the U.S. FDA for its Pithampur Unit-3 facility, following a July 7–17 inspection. The facility manufactures key products including metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. The EIR indicates closure of the inspection with no adverse findings, signaling compliance with current Good Manufacturing Practices (cGMP)—a positive development amid past regulatory scrutiny at other Lupin facilities. Managing Director Nilesh Gupta welcomed the outcome, reaffirming the company’s commitment to quality and global standards in delivering affordable medicines. With 15 manufacturing sites and 7 R&D centers worldwide, Lupin continues to strengthen its global standing. This clearance reinforces confidence in its manufacturing capabilities and supports its presence across 100+ markets in critical therapy areas like respiratory, cardiovascular, and anti-infective care.