Dipharma Francis S.r.l., a global contract development and manufacturing organization (CDMO) and manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients and advanced intermediates, has completed the expansion of its research and development center for small molecules at its headquarters in Baranzate, 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.

According to the company, the new area further expands Dipharma’s R&D network, which is composed of advanced R&D hubs in Italy and in the U.S., 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 characterization 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, CEO, 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.”