Press Room

Press Release / Dec 17, 2014

Successful FDA inspection at Hovione

Hovione today announced that the FDA performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings.

 

Loures, Portugal, December 17th, 2014 – Hovione today announced that the U.S. Food and Drug Administration (FDA) performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings. At the conclusion of the inspection, the FDA issued a Form 483 with three inspectional observations. 

The inspection carried out by the FDA Investigator Mr. Ramon Hernandez and by the Chemist, Mr. Jose A. Lopez Rubet, lasted 5 days as initially planned, started on 1st December and concluded on the 5th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP).

On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "Addressing these observations is the top priority of the site management and the points raised will be replied to within 15 working days from the receipt of the Form 483. We are taking this result to improve our quality system both here and at our other sites.  The investigators spoke positively of many of our initiatives.  We have a strong pipeline of products under development with new NDAs being filed in the next 12 months, and we need to work diligently to continue to deserve our clients’ trust”.

“We have a culture of quality that puts patient safety first. This shapes our behaviors and motivates us to improve. This is a Team effort, and I am very encouraged to see everyone so committed.” said Guy Villax, Chief Executive.

 

About Hovione
Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Also in the Press Room

See All

Twenty companies presented at the annual kickoff to DCAT Week. The Drug, Chemical & Associated Technologies Association (DCAT) opened DCAT Week 2026 with its Member Company Announcement Forum. The kickoff to the annual event in New York City, underway from March 23–26, 2026, showcased 20 companies. These were selected based on their announcements’ “news priority, criticality, and interest” to DCAT member companies. The following is a summary of highlights from the presentations, supplemented by additional information provided by some of the companies. (...) Hovione Hovione’s Vice President of Technical Operations for the Americas, David Basile, delivered the company’s Member Company Announcement Forum presentation. Basile will be speaking exclusively with Contract Pharma during DCAT Week, so check back for more on Hovione’s latest.   Read the full article at ContractPharma.com    

Press Clipping
Contract Pharma, 23 March 2026

DCAT Member Company Announcement Forum 2026: An Inside Look

Mar 23, 2026

With more than six decades of experience in pharmaceutical development and manufacturing, Hovione is an international CDMO offering a comprehensive range of services for New Molecular Entities (NMEs), including drug substances, intermediates, and drug products. The company also supplies niche generic APIs and delivers advanced technologies supporting multiple drug delivery platforms, including oral, injectable, inhalation, and topical formulations.  Today, Hovione employs 2,500 people worldwide and operates 900 m3 of manufacturing capacity across four sites in Europe, the U.S. and Asia. Japan has played an important role in the company’s global strategy since its early years. Initial export activities were followed in 2017 by the establishment of a Japanese subsidiary in Osaka.   Read the full article in Japanese at Yakuji.co.jp Read the article translated in English  

Press Clipping
Yakuji Nippo Magazine, 13 March 2026

International CDMO strengthens its presence in Japan: from active pharmaceutical ingredients to formulations, all at the same location

Mar 13, 2026

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).    

Article
Executiva, 23 February 2026

Hovione’s Diane Villax: “I was not brought up to be a business woman”

Feb 23, 2026

Also in Events

See All