US FDA inspects Divis Labs' Hyderabad plant

Divis Laboratories Ltd has informed BSE that it has had a successful inspection by the US FDA from June 16-20, 2014, without any observations, for its Unit-I at Choutuppal Mandal near Hyderabad during this month. The purpose of this inspection was for general current Good Manufacturing Practices (cGMP) for the facility, said Divis Laboratories.
 
Divis Laboratories, which focusses on developing new processes for the production of active pharmaceutical ingredients (APIs) & intermediates, has two manufacturing facilities located at Hyderabad and Visakhapatnam.
 
Developed on a 500 acre site, Divis Labs’ Hyderabad manufacturing facility comprises of 13 production buildings pilot plant and a kilo lab. As per company website, the facility was successfully inspected by US-FDA in Feb 2008 (which itself was a third inspection; the first two are in Sept 2000 and April 2004).