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Quality Highlights

  • An Impressive track record in filing regulatory documents in CTD (common Technical documents) format, worldwide and recently in eCTD format.


  • Filing of IMPD and approval of Clinical trial application to conduct clinical study in EU


  • Filing of Dossiers for Human Insulin formulations with product registered in 27 countries


  • Drug Master files for small molecules and registration of the same in EU through Mutual recognition procedure (MRP) and Decentralised procedures (DCP)


  • In the small molecule category comprising statins, immunosuppressant’s, anti-obesity and anti-diabetics, Biocon has been granted 8 CEPs by EDQM, and submitted more than 300 DMF for the regulated markets.


  • Dossiers for Oral formulations and parenterals


  • Approval for our products and testing facilities by the Indian state and central Drug Control Authorities


  • For the period between April 2011 and March 2012, Biocon has undergone 62 successful compliance audits by various national and international customers and regulatory authorities.


 
     
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