Biocon Sdn Bhd, a subsidiary of Biocon has received the Establishment Inspection Report (EIR) from the US FDA for the pre-approval inspection (PAI) of its insulins manufacturing facility in Malaysia, for insulin glargine. The inspection was conducted between February 10 and 21, 2020.
The inspection has been closed with a VAI (voluntary action indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in February 2020. This is an endorsement of our commitment to global standards of quality and compliance.
Also read: Lupin’s IRC receives EIR from USFDA
The closing of the USFDA inspection of our Malaysia facility is an important milestone in our journey of developing insulin glargine for patients in the US. Our insulin glargine (Semglee) application filed by our partner Mylan, with the US FDA under the 505(b)(2) NDA pathway, is currently under review., said the company spokesman.