The Hyderabad-based Saraca Laboratories Limited, a Virchow Group company and a manufacturer of bulk drugs and intermediates, is gearing up to get US FDA approval for its manufacturing facility located at Gadda potharam Village, in Jinnaram Mandal of Medak District of AP.

US FDA will soon inspect the facility and approval for the facility is likely to come by the end of 2005, Dr Hemanth Nandigala, Virchow Group, told Pharmabiz.

Saraca, which started production of Ranitidine Hcl in 1998, is now one of the largest producers of Ranitidine Hcl in the world. The production plant comprises four production blocks with over 100 reactors, along with a full-fledged R &D centre. The company’s facility currently has WHO-GMP and ISO 14001 certifications.

Virchow Group comprises six active pharmaceutical ingredient (API) and drug intermediate manufacturing units and two biotech units. The flagship company of the group, Virchow Labs is today the largest producer of Sulfamethoxazole in the world, meeting nearly about 80 per cent of the global need.