SME Times News Bureau | 15 Jun, 2019
The European Medicines Agency (EMA) has certified the Biocon drug
product and substance facilities in the city's southern suburb for good
"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.