Regulatory Authorization Italian Medicines Agency Approves New Line at Dipharma’s cGMP Pilot Plant
Dipharma’s new production line at the cGMP pilot plant will help the company to double its capacity to process projects in the fields of generics and CDMO. Located in the firm’s Mereto di Tomba facility in Italy, the pilot plant can produce batches ranging from 5 to 50 kilograms.
Milan/Italy – Dipharma, a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, recently announced that the Italian Medicines Agency (Aifa) approved the brand-new production line at the cGMP pilot plant suite, located in its facility of Mereto di Tomba (Italy).
The expansion includes a further two glass-lined and two stainless steel reactors, along with a Hastelloy C-22 filter-dryer having a continuous liner discharge, featuring a full closed-system handling approach. With this state-of-the-art investment, Dipharma doubles its capacity to process projects for customers, both in the generics and CDMO arena, while enhancing operational safety and isolation technologies.
Already fully operational, the current pilot plant configuration consists of two independent production lines and can produce batches ranging from 5 to 50 kilograms under the most rigorous cGMP conditions, providing flexibility to develop the most effective chemistry prior to moving to production scale.
“We have experienced an unprecedented increase in demand for our services,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis, “particularly for small-scale projects, and the regulatory approval of our new pilot line enables us to better fulfill our customers’ requests and expectations, expanding our network capabilities and reinforcing our integrated services to materialize their projects. This expansion is the latest in a series of strategic investments we are planning in our facilities at all scales to enhance Dipharma’s competitiveness and offer to our international pharma clients a full partnership all the way from preclinical to commercial”.