Commercial Scale
Freedom to Operate – Solid phase custom manufacture

First and foremost, Girindus has executed license agreements that give us the freedom to operate solid phase oligonucleotide manufacturing processes utilizing technologies covered under certain patents. The licenses cover key steps in the manufacturing processes to be used in the manufacture of all major classes of oligonucleotides (including the steps of detritylation, activation of phosphoramidites, sulfurization […]

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Commercial Scale
FDA Inspection

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 […]

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