The Hyderabad-based life science company Suven Life Sciences, an ISO 9001, ISO 14001 and OHSAS 18001 company, has undergone US FDA renewal inspection at their facility in Pashamylaram near Hyderabad for manufacture and supply of active pharmaceutical ingredients (bulk drugs), intermediates and formulations under cGMP.
Based on the inspection and the review thereafter US FDA has classified Suven facility at Pashamylaram as acceptable for manufacture and supply of active pharmaceutical ingredients, intermediates and formulations.
So far Suven Life Sciences has filed 29 DMF's and one ANDA from this facility which is FDA complaint under cGMP and continued after renewal inspection.
Suven LifeSciences has 12 internally discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and schizophrenia.