Suven Life's unit receives USFDA acceptance

Company has so far filed 29 drug master files and one abbreviated new drug application from the Pashamylaram facility

The US Food and Drug Administration (USFDA) has classified Suven Life Sciences facility at Pashamylaram near Hyderabad as acceptable for manufacture and supply of active pharmaceutical ingredients, intermediates and formulations.

Suven is engaged in contract research and manufacturing services (CRAMS) since 1995 and drug discovery and development support services (DDDSS) since 2005. It has so far filed 29 drug master files and one abbreviated new drug application from the Pashamylaram facility.
 
The company stated in a press release on Wednesday that the US health regulator gave its acceptance after inspection and review of the facility.

Suven said that it currently has 12 internally-discovered therapeutic drug candidates in pre-clinical stage of development targeting conditions such as attention deficit hyperactivity disorder (ADHD), dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia.