The inspection was conducted between February 20 to 26, 2020 and EIR has been closed with a “VAI” classification.
The share price of Biocon gained 3.5 percent in the early trade on March 20 after the pharma company received an establishment inspection report (EIR) from the US drug regulator.
The company received EIR from the US Food and Drug Administration (FDA) for the post-approval and GMP inspection of its small molecules API manufacturing facility on Biocon Campus in Bengaluru.
The inspection was conducted between February 20 to 26, 2020 and EIR was closed with a “VAI” classification for the observations.
At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and were being addressed by the company, it said.
At 0920 hours, Biocon was quoting at Rs 261.00, up Rs 8.45, or 3.35 percent, on the BSE.