Dipharma Receives Regulatory Authorization for the New Line at Its cGMP Pilot Plant

Thanks to the approval by the Italian Medicines Agency (AIFA), the Company increases its efficiency and is able to face the growing demand for its services.

MILAN--(BUSINESS WIRE)-- Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today 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).

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New Dipharma cGMP pilot plant line, located in the Italian facility of Mereto di Tomba (UD). (Photo: Business Wire)

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 S.r.l. —, 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.”

About the Dipharma Francis group
With revenues over €137 million, Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with more than 500 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centers develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. As a third-generation family-owned company, Dipharma has a long history if stability, commitment, and financial solidity. Since 1970, Dipharma has managed to achieve a positive unbroken record of inspections by the main Regulatory Agencies and its cGMP manufacturing sites are equipped to supply quantities from laboratory to industrial scale. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust.

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