Press Room

Press Release / May 09, 2011

New Products at Hovione, 6 inspections in 8 months

Loures, Portugal, May 9th, 2011 – Hovione today announced that in the past 8 months the Company has had a large number of GMP inspections

Hovione today announced that in the past 8 months the Company has had a large number of GMP inspections by the major Medicines’ Agencies.

The Japanese PMDA inspected our sites in China and Portugal. The US FDA inspected our sites 3 times: Loures twice and New Jersey once. The Portuguese authorities also performed an inspection in April. In the last week of April FDA inspected simultaneously both New Jersey and Loures, in both cases no Form 483 was issued. The PMDA inspections have also been closed successfully.

On the outcome of the PAI in Loures Luisa Paulo, Director of Compliance at Hovione, commented: “This was the best pre-approval inspection ever by FDA. The investigators were very experienced and very well prepared; they had studied the file in great detail. This was a Quality by Design submission and a key element of it was a continuous process – so the discussions were really interesting. We definitely broke new ground.”

The large number of inspections reflects the constant flow of submissions that Hovione clients make. Innovator drugs, generics, devices all make use of Hovione APIs or of its technologies that focus on particle properties in high performing formulations. “Our clients are thrilled. Successful outcomes at inspections is not an unusual event at Hovione, but to continue with this kind of stellar record in the current climate is something that makes us all really proud “ said Guy Villax, Hovione’s CEO.

About Hovione

Hovione is an international company with over 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

For more information about Hovione, please visit the Hovione site at www.hovione.com  or contact Corporate Communications, Isabel Pina, +351 91 7507 462 or + 351 21 982 9362, e-mail: ipina@hovione.com.

 

 

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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

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