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2 Feb 2023

Dipharma completes second phase of CGMP expansion at its Kalamazoo site

A Quality Control chemist performs a test in the new Dipharma CGMP QC lab at the Kalamazoo site (MI), US.

The Company continues to strengthen its capabilities in the North American market

Milan, Italy – Dipharma Francis S.r.l. (Dipharma), a global CDMO and leading manufacturer of Active Pharmaceutical Ingredients and advanced Intermediates, announced today the completion of the second phase of expansion of its American site, Dipharma Inc., located in Kalamazoo, MI. (US).

The new investment provides additional CGMP, Quality Control laboratory and warehouse spaces, increasing the capability of the American site to support and expand its CDMO services.The state-of-the-art QC laboratory is designed and equipped according to the latest pharmaceutical quality standards, with full 21CFR Part 11 compliance for Electronic Data Integrity, and the new warehouses are fully-climate controlled and allow enhanced material storage with increased material segregation.This expansion follows the 2020 opening of the dedicated CGMP Kilolab and QC laboratory.

The third phase of the project is ongoing and will expand the current Kilolab by adding a second CGMP line. The new line will be capable of running larger-scale reactions, up to 85 L while also expanding our cryogenic reaction and solid isolation capabilities.The third phase is expected to be completed by the 2nd quarter of 2023.

“Expanding and upgrading our US operations enhances Dipharma’s CDMO portfolio, allowing us to offer a wider and more customized set of solutions designed to meet the most stringent customer requirements — said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. — These activities compliment strategic investments underway at our Italian facilities, including doubling our pilot plant capacity and others with the aim to further strengthen Dipharma’s capacity and support the growing demand from our worldwide partners at all phases of development”.

About the Dipharma Francis groupWith revenues over €137 million, the Dipharma Group is a global CDMO and a leading manufacturer of 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 U.S.A. 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. Experience you can trust.

For more information:Paola Clerici
Communication Manager
Dipharma Francis S.r.l.
E-mail: [email protected]

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