IGMPI India



US FDAs inspection of Divis Labs' Hyderabad plant successfully completed

Divis Laboratories Ltd. had a successful inspection by the US FDA from 16th to 20th June, 2014, without any observations, for its Unit-I at Lingojigudem, Choutuppal Mandal, near Hyderabad during this month. This inspection was performed for general current Good Manufacturing Practices (cGMP) of the facility.

Divis Laboratories, primarilyfocuses 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, the Divis Labs Hyderabad manufacturing facility comprises of 13 production buildingspilot plant and a kilo lab. The production buildings have clearly defined finished product areas for APIs with clean air, purified water systems that operate under full cGMP as per US-FDA guidelines. The facility was successfully inspected by US-FDA in Feb 2008 (which itself was a third inspection; the first two in Sept 2000 and April 2004).

The Hyderabad facility has been certified for the following management systems: ISO 9001 certified for its Quality systems, ISO 14001 certified for its Environment Management and OHSAS-18001 certification for its Occupational Health and Safety systems.