Bengaluru: The European Medicines Agency (EMA) has certified the Biocon drug product and substance facilities in the city’s southern suburb for good manufacturing practice.
“We have received a certificate from EMA for the good manufacturing practice compliance by our biological drug product and substance facilities at Bengaluru,” said the city-based leading biotech firm in a statement on Saturday.
In March, the European regulator (EMA) inspected the twin facilities where a range of bio-similars are manufactured. “It was a surveillance inspection of our facilities and a pre-approval inspection of our additional manufacturing line,” said the statement.
The international certification would enable the company to address the patients’ needs in the European Union (EU) markets and enhance access to its bio-similars, said a Biocon’s spokesperson in the statement.