The European agency inspected Bengaluru unit in March 2019.
Biocon shares fell 3 percent intraday to hit a 52-week low of Rs 248.30 on June 14 despite company getting certificate of good manufacturing practice from the EU regulator for its Bengaluru unit. The stock closed at Rs 248.90, down 2.93 percent.
These facilities are used for the manufacture of portfolio of biosimilars.
The European agency inspected Bengaluru unit in March 2019. "This was a surveillance inspection of our existing DP and OS facilities and a pre-approval inspection of our additional DP manufacturing line," company said in its filing.
"Biocon has received the Certificate of GMP compliance from EMA for its Biologics Drug Product (DP) as well as Drug Substance (DS) facilities at Biocon Park, Bengaluru," it said.
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