Dipharma Expands its Italian R&D Center to Increase its Analytical Services

Dipharma Francis S.r.l. recently announced the completion of the expansion of its Research and Development Center for small molecules at its Headquarters located in Baranzate, close to Milan, in the North of Italy.

The new space, which increases the Italian laboratory space dedicated to analytical R&D activities by over 130%, will strengthen Dipharma’s analytical capabilities and techniques and will broaden expertise for the development of new organic synthesis methods and technology to target and offer a wider range of new APIs and advanced intermediates.

It is designed and equipped according to the latest quality and safety standards, with state-of-the-art instrumentation, including a brand new 500 MHz NMR, and is managed through cloud-based integrated data systems.

The new area further expands Dipharma’s R&D network, which is composed of advanced R&D hubs in Italy (Baranzate) and the US (Kalamazoo, MI), and the R&D laboratories located in each facility. They support faster and more reliable product scale ups and tech transfers between sites.

Dipharma’s R&D expertise includes, in addition to analytical method development services, synthesis, isolation and characterisation of impurities, expertise in solid-state studies and preformulation, elemental impurities and potentially genotoxic impurities, including nitrosamine, risk assessment and detection, toxicological assessment and commercialization services. The R&D team is supported by an internal Intellectual Property department, with extensive experience in patent evaluation, NIS services and patent litigation.

“This expansion boosts Dipharma’s R&D services and is part of an investment strategy aimed to increase our capabilities and skills to better support our valued custom synthesis and generic API customers with innovative and more efficient solutions in all phases of API development and manufacturing,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. “Our R&D team has grown strongly in the last years, both in Italy and in the US, and the number of Italian researchers has increased by more than 40% since 2020 and it will continue to grow in the future. The new space will provide a state-of-the-art working environment to meet the most stringent requirements from our customers.”

With revenues over €137 million, the Dipharma Group is a global CDMO and a leading manufacturer of New Chemical Entities (NCE), APIs and advanced Intermediates for Generic and Contract Manufacturing markets, with more than 500 skilled and highly committed employees and 4 CGMP plants, located in the US and Italy. 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 of 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. For more information, visit www.dipharma.com.