BRIEF—Satisfactory French inspection of Lupin's Mandideep facility

7 August 2019

Indian pharma major Lupin Limited has announced the completion of the Good Manufacturing Practices (GMP) Inspection of its finished product manufacturing facility (Unit-1) at Mandideep, by the French National Agency for Medicines and Health Products Safety (ANSM).

The inspection was conducted between April 8, 2019 and April 12, 2019.

The ANSM inspection closed with no critical or major observations.

Because of the cooperation agreements between US and European Union medical regulatory authorities, this plant inspection will also be acceptable to other agencies in Europe as well at the US Food and Drug Administration.