Laboratorium Ofichem, the Ofichem Group’s production facility of APIs, is a flexible, high-tech environment that can be adapted to meet clients’ needs, from large-scale standard orders to milligrams of a specialised product.
“Our facility has thirteen production suites which can be subdivided into large-scale, medium-scale and small-scale production rooms” says Alessia Cogotti, Director at Lab Ofichem. “And as each production suite has its own goods and clothing lock and pressure regime, there’s absolutely no risk of cross-contamination. Which means we can safely and simultaneously produce a broad range of APIs for the human and veterinary pharmaceutical markets.”
“The flexibility of the production lines enable us to quickly and easily respond to client demands and change products and production to meet tight deadlines. It creates a dynamic working environment that draws on the close collaboration we have between our teams and with our clients and external partners so as to ensure product quality and safety.”
Lab Ofichem CMO
Lab Ofichem CDMO provides the highest quality at each step of the production process. Our industrial and technological expertise means our pharmaceutical, veterinary and nutraceutical customers can place a complete order or simply select from a range of services. These include validation of an analyses method, developing a new product revival of old molecules, and filing a Drug Master File.
The flexibility of the production lines is a reflection of the diversity of Lab Ofichem’s activities. In addition to the production and development of APIs, Lab Ofichem also analyses APIs for external parties, validates analytical methods for API production, and compiles Active Substance Master Files for new and existing products. It’s a diverse range of tasks but quality control is the common theme throughout. “Our staff have to have a thorough understanding of both product regulations and laboratory and production guidelines. We work in line with Good Manufacturing Practices and we’re GMP, FDA, FAMI-QS and ISO certified. And as our lab is equipped with the very latest technology, we’re ahead of the regulations.”
THE FLEXIBILITY OF THE PRODUCTION LINES ENABLE US TO QUICKLY AND EASILY RESPOND TO CLIENT DEMANDS AND MEET TIGHT DEADLINES