The production is supported by an organized company quality system with different objectives:

meet the therapeutic requirements;
meet the requirements of the customer;
develop and produce devices in full compliance with the reference standards (EU-GMP FDA regulation).

The Capua plant has AIFA’s Good Manufacturing Practice (GMP) approval and that of the main drug authorities in the major international markets: EMA, FDA, Ministry of Health and Welfare (Taiwan), Ministry of Industry and Trade of the Russian Federation, Health Canada and more.

The compliance of the plant with the reference standards is confirmed periodically by inspections and controls, while for the environmental management system we are in possession of the UNI EN ISO 140018 (SGS) Certification since 2002. This legislation, which lays down the necessary requirements to develop our environmental performance in order to make us active promoters of sustainable development, is adopted not only in the production field, but in general in all business activities.

The principles that guide our company choices are as follows:

making environment respect a priority in our business strategies;
to undertake to inform, train and motivate our staff and suppliers to carry out their work in a safe and environmentally responsible way;
ensuring a healthy and safe working environment for our employees;
pursue a total control of the production process to ensure a safe and quality product for patients.
innovate and work with a view to lean production to aim at the excellence of all business processes;

Orabloc - Articaine Hydrochloride Injection - Brochure