Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received unannounced systems audits by the FDA in 2007 and in 2010. The audits included small molecule and oligonucleotide manufacturing areas. The results were exemplary: no form 483 and no objectionable findings.
Our FDA registration number is: 3003270485
For detailed information please contact our Business Development Team.