Dipharma builds cGMP manufacturing suite at US subsidiary

24 Feb 2020

Italy’s Dipharma Francis has completed construction of a new cGMP manufacturing suite at its US subsidiary, Kalexsyn, strengthening its service offering and ensuring continuity across the product lifecycle from preclinical to commercialisation , the contract research and development organization announced Monday.

The suite comprises a quality control laboratory --designed and equipped according to latest pharmaceutical quality standards with full CFR21 compliance for data integrity management—and a kilo lab, Dipharma said.

Dipharma builds cGMP manufacturing suite at US subsidiary
Dipharma's kilo lab at its CDMO site, Kalexsyn, in Kalamazoo

“The new suite marks the achievement of a key milestone within the Exclusive Synthesis growth strategy and reinforces the company’s value proposition to provide reliable innovative solutions to customers: Dipharma Group is now able to cover the whole pharmaceutical chemistry services spectrum, from discovery to marketed drugs,” said Jorge Nogueira, CEO of Dipharma Francis.

He added that with the addition of the new kilo lab, Dipharma has implemented cGMP capability at Kalexsyn, enhancing its range of exclusive services from contract research organisation to CDMO.

With an engineering batch already scheduled for production, Dipharma said it is currently assembling all documents required by the US Food and Drug Administration for Drug Establishment Registration.

Dipharma, which also manufactures active pharmaceutical ingredients, has offices in Italy, the US and China. It bought the then CRO Kalexsyn in 2018.