On the 22nd September 2017 Granules OmniChem Limited (GOC) received the Establishment Inspection Report (EIR) from the US-FDA
On the 22nd September 2017 Granules OmniChem Limited (GOC) received the Establishment Inspection Report (EIR) from the US-FDA following the successful on-site inspection that had been carried out over 5 days from the 5th to the 9th December 2016 by 2 US-FDA Investigators. This was a Pre-Approval Inspection (PAI) for a commercial custom manufactured product of a leading pharmaceutical company
GOC was established in 2011 as a 50:50 joint venture between Ajinomoto OmniChem and Granules India Ltd. It is a CRAMS business with operations in Vizag India, from where it serves a number of the world’s leading pharma companies. The site has undergone numerous successful quality audits by these leading pharmaceutical companies.
The site was purpose built around OmniChem’s proven operational design to support innovator pharma companies with larger volume, late clinical development and commercial Intermediates and APIs. The site has been operational since 2014, the second wave of expansion is currently being designed. The management processes; technical transfers; business development and project management all benefit from the close support given by OmniChem.