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Quality
Accreditations & Approvals
Internal Quality and EHS Accreditations
- Received ISO 9001 accreditation in 1993 and recertification
for ISO 9001:2008
- Implemented an integrated Environment, Health and
Safety management system
- ISO 14001:2004 certification
- OHSAS 18001:2007 certification
Facility Approvals
- USFDA approved facilities; Biocon Campus (2000, 2003, 2006) and Biocon Park (2006)
Recent USFDA inspection in January 2009 for both facilities. Customers received their ANDA approval referring to these sites.
- EUGMP Certification for Biocon Campus (2004, 2005, 2006) and Biocon Park (2006).
Recent EUGMP inspection for Biocon Campus in 2008.
- Mexican Health Authority approval for both Biocon Campus and Biocon Park facilities in 2006.
- Cuban approval for both Biocon Campus and Biocon Park facilities in 2007.
- Jordan FDA approval for both Biocon Campus and Biocon Park facilities in 2008.
- Anvisa (Brazil) approval for both Biocon Campus and Biocon Park facilities in 2008.
- The Iran Ministry of Health inspected and approved oral formulations of Immunosuppressant category.
- Nepal Health Authority inspected and approved BioMab facility.
- UAE ministry of Health granted facility approval for both Biocon Campus and Biocon park facilities in 2007
- National Agency of Food and Drug Control, Indonesia inspected both facilities.
- Received a number of CoPP (Certificate of a Pharmaceutical Product) certificates as per WHO norms.
- Schedule – M GMP Certification for both Biocon Campus and Biocon Park facilities as per D&C act, India
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