Biocon gets EIR from USFDA for Bengaluru biologics unit
New Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its biologics drug product unit at Bengaluru. The US Food and Drug Administration has said the inspection is closed. The company had undergone good manufacturing norms compliance inspection of the unit from August 22-30, Biocon said in a regulatory filing.
Commenting on the development, Biocon Biologics CEO Christine Hamacher said, "The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the US".
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The facility is a strong building block for the company's USD 1 billion revenue target, Hamacher added.
The USFDA had in October approved Biocon's new drug product filing for biosimilar Trastuzumab 150mg vials at the biologics facility in Bengaluru following a pre-approval inspection in September, the company said.
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