The building is located in an area of 10,000 m² , with a covered area of 1,750 m² . The building process ended in March 1999 and the building was modernized in 2001, in accordance with GMP standards. Special care was taken when optimizing technological design and when performing innovations so as to take into account environmental safety and protection.

The production sector has thermal insulation, sanitary baseboards, inlaying hermetic lighting, dust extraction systems, air conditioning, refrigeration equipment, humidity and temperature control equipments, controlled atmosphere, pressurization, compressed air, inverse osmosis for purified water, treatment of effluents and studies on environmental effects.

APPROVALS AND AUTHORIZATIONS

The plant is authorized by the National Administration of Drugs, Foods and Medical Technology (ANMAT), by the National Institute of Drugs (Instituto Nacional de Medicamentos, INAME), by the National Ministry of Health and Environmental (complying with GMP regulations), and by the Municipality of Gualeguaychú.

PRODUCTION AREAS

The laboratory has three different areas to produce, fractionate and store each product and raw materials.

It has the state-of-the-art technological equipments in each sector that assures the fulfillment of national and international norms in the production of pharmaceutical specialties under the regulations of GMP.

It also has an important control laboratory with lots of equipment for different purposes: physical-chemical controls with High Performance Liquid Chromatography [HPLC], spectrophotometers, dissolutors, disintegrators, fusion devices, muffles, gas heaters, hardness testers, pH-metres, magnetic agitators, rotors, etc.; microbiological control through laminar flow, autoclaves, culturing furnaces [bacteriological incubators], inverse osmosis equipment, among others.

The Pharmaceutical area is equipped with control devices, mills, sifters, mixers and formulating equipment; rotary compressors, coating, strip and blister machines; liquid fillers, packing machines, vertical wrapping machines; Form Fill and Seal machines, FFS; pouches, packs and thermo packs fillers; driers, thermo contractible ovens and other equipment, allowing this area to produce a wide range of formats and presentations.