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Quality
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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