Biocon gets European nod for biologics facilities in Bengaluru

New Delhi: Biocon Ltd Friday said it has received good manufacturing practice compliance certificate from the European Medicines Agency(EMA) for its biologics facilities in Bengaluru.

The biotechnology major has received the certificate for its biologics drug product and drug substance facilities at Biocon Park, Bengaluru, the company said in a filing to BSE.

These facilities, used for the manufacture of Biocon's portfolio of biosimilars, were inspected by the European agency in March 2019, a company spokesperson said in a statement.

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"This was a surveillance inspection of our existing drug product and drug substance facilities and a pre-approval inspection of our additional drug product manufacturing line," the statement added.

This certification will enable the company to continue addressing the growing needs of patients in the EU markets and enhance access to its high-quality biosimilars, it said.

"We remain committed to global standards of quality and compliance," it added.

Based in Bangalore the company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe. It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations.

The company’s biosimilar products are also sold in both bulk and formulation forms in several emerging markets. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon, is engaged in the business of integrated end-to-end drug discovery and development services.

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