Biocon gets EIR for insulin facility in Malaysia from USFDA
Biocon Limited’s subsidiary Biocon Sdn Bhd has received an establishment inspection report (EIR) from USFDA for the pre-approval inspection (PAI) of its insulin’s’ manufacturing facility in Malaysia for Insulin Glargine.
The inspection was conducted from February 10-21, 2020. It closed with a voluntary action indicated (VAI) classification in the EIR, for three observations issued at the conclusion of the inspection in February 2020.
The closing of USFDA inspection of its Malaysia facility is an important milestone in the company's journey of developing Insulin Glargine for the patients in US. Also, the company’s Insulin Glargine (Semglee) application filed by its partner Mylan, with USFDA under 505(b)(2) NDA pathway, is currently under review.
In the month of March 2020, the company had received EIR from USFDA for the post-approval and GMP inspection of its small molecules API manufacturing facility at 20 km, Biocon campus (Bengaluru). At the conclusion of the inspection last month, the agency had issued form 483, with two observations.
On Wednesday, the stock of Biocon jumped 5.4 per cent to Rs 285.40 in the early morning trading session from its previous close of Rs 270.60 on BSE.