News + Font Resize -

Suven's Hyderabad API facility to get US FDA nod
Our Bureau, Hyderabad | Monday, June 11, 2007, 08:00 Hrs  [IST]

Suven Life Sciences Ltd, an ISO 9001, ISO 14001 and OHSAS 1801, announced that company has undergone US FDA inspection at their facility in Pashamylaram, near Hyderabad for the manufacture and supply of active pharmaceutical ingredients (bulk drugs) under cGMP.

Based on the inspection and the review thereafter US-FDA has classified the company's facility at Pashamylaram as acceptable for manufacture and supply of active pharmaceutical ingredients.

So far the company has flied eight DMF's from this facility which is now FDA complaint under cGMP. With partner ANDA approvals the company can supply the active pharmaceutical ingredients in future thus generating new revenues in due course of time.

The company is a Hyderabad based Life Science Company, a Collaborative Research Partner (CRP) in Drug Discovery for a global Pharma major since 2006 is a pioneer in contract research and manufacturing services (CRAMS) since 1995 and Drug Discovery and Development Support Services (DDDSS) since 2005.

The company is engaged in discovering new chemical entities in central nervous system (CNS) therapeutic areas Viz, alzheimer's, cognitive impairment, dementia, depression, parkinson's disease and obesity which are at various phases of preclinical development.

A focused provider of DDDSS for development of new chemical entities to life sciences companies, the company's commitment to protection of intellectual property, maximization of return on R&D investment for collaborative research partners, ability to offer full spectrum of services from discovery to market launch and provide technologies and expertise in different therapeutic areas. The company has R&D strength of more than 190 professionals with the state of the art infrastructure for drug discovery and development activities with 40 clinical research professionals and the front-end project management services from New Jersey, USA.

Post Your Comment

 

Enquiry Form