India’s Biocon has received an Establishment Inspection Report (EIR) from the US regulator for its biologics factory in Bengaluru.
The EIR certifies that a routine cGMP inspection of the Indian facility, which took place in August, has been: “successfully closed.”
Biocon Biologics chief executive Christiane Hamacher said: “We are pleased to receive the EIR from the US FDA for our large Biologics Drug Product facility in Bengaluru, which is a strong building block for our $1 billion revenue target.”
In August, Biocon's Malaysia Insulin Glargine manufacturing facility received the Certificate of GMP compliance from the European Medicines Agency.
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