Status of EMA Dossiers

  • Posted by: Biocon Biologics

Bengaluru, Karnataka, India, August 16, 2017:

As previously communicated, whilst our drug substance facilities for Trastuzumab and Pegfilgrastim were approved, the European regulatory authorities had informed us of the need for a re-inspection of our drug product facility for these products.

The request for withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this re-inspection and will be considered by the EMA´s Committee for Medicinal Products for Human Use (CHMP).

We are on track to complete our corrective and preventive actions (CAPAs) by the end of this quarter and it is our intent to seek re-inspection and re-submission thereafter.

– Company Spokesperson

Author: Biocon Biologics
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