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Dear Readers,Welcome to the latest issue of Microb
Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (cdmo) and a global manufacturer of Active Pharmaceutical Ingredients, announced today another new production site of the Group, the facility located in Caronno Pertusella, near Milan (Italy), has received the Good Manufacturing Practice (gmp) certification – CBPF (Certificado de Boas Práticas de Fabricação) – from the Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária).
This authorization joins the previous one, obtained in November 2022, by the Dipharma Italian site located in Baranzate (Milan), and certifies Dipharma world-class quality system, which has been widely recognized by regulatory authorities. The Caronno Pertusella facility has been regularly and successfully inspected by the US FDA and the Italian Ministry of Health (AIFA) for more than 50 years.
“We are very proud to have reached another regulatory milestone: this second successful completion of the ANVISA certification recognizes another Dipharma site as being in compliance with the GMP requisites as foreseen by the Brazilian requirements,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. — “Our Company is committed to providing innovative and competitive solutions to our customers and this achievement once again certifies we are an ideal partner for registering new applications at ANVISA.”
With revenues over €140 million, the Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with more than 550 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 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.
