Press Room

Press Release / Mar 08, 2018

Compliance at Hovione - Annual Inspection Review

Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities.

Loures, Portugal, March 8, 2018 – Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections revealed that all Hovione sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture.

This is the first press release that reports on the outcomes of inspections in the previous year. This will now be a regular commitment, it is another feature of our commitment to transparency.

Hovione inspections during 2017

Site	Authority	Date	Type of inspection	Outcome
Portugal	Ministry of Healthcare of the Russian Federation	Jan 2017	PAI for an Intermediate Drug Product	GMP certificate granted
	Ministry of Healthcare of the Russian Federation	Jul 2017	PAI for an Intermediate Drug Product	GMP certificate granted
	FDA, USA	Mar 2017	PAI for an Intermediate Drug Product	Form 483 – 6 observations Site approved
	FDA, USA	Nov 2017	Surveillance inspection	No Form 483
	INFARMED, Portugal, EU	Jul 2017	GMP inspection to a new building	GMP certificate granted
Macau	PMDA, Japan	Dec 2017	GMP inspection	11 minor observations reported
Ireland	Ministry of Healthcare of the Russian Federation	Jul 2017	PAI for an Intermediate Drug Product	GMP certificate granted
Ireland	FDA, USA	Dec 2017	Surveillance inspection	No Form 483

“Each inspection at Hovione is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.” said Joerg Gampfer, Vice President of Quality at Hovione.

“We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.” added Frédéric Kahn, Vice President Marketing and Sales.

About Hovione
Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.

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Hovione has once again solidified its position as a top employer in all four of its manufacturing sites - Lisbon (Portugal), Cork (Ireland), East Windsor (NJ, USA), and Macau. The program highlights the company’s significant advancements in several critical areas, including Purpose & Values, Diversity, Equity & Inclusion (DEI), Employer Branding, and Recognition & Rewards, driven by sustained investment in people. This certification from the Top Employers Institute follows a rigorous audit process and underscores Hovione’s consistency in investing in people and world-class workplace practices, as well as the unwavering commitment of its more than 2,300 employees to the company's core purpose and values. “This recognition reflects the exceptional dedication and collaboration of the entire Hovione team,” said Jean-Luc Herbeaux, Chief Executive Officer. “Hovione is a development and manufacturing service company operating in one of the most demanding and regulated industries. We understand that our success is deeply rooted in our people. Together, as One Hovione, we are committed to continuously refining our people practices to foster a workplace that inspires motivation and enhances employee satisfaction, so that, every day, our team members bring their best selves to work, driving innovation and excellence at every step.” Macau, which became the first company in the region to achieve Top Employer certification last year, has successfully renewed the status, solidifying Hovione’s global leadership in workplace excellence. With its consistent Top Employer recognition, Hovione demonstrates that the talent strategy is perfectly aligned with the business strategy. Watch Ilda Ventura, Senior Vice-President of Human Resources and Member of the Management Board of Hovione, video about what this certification means for Hovione. For additional information, please read the press release.

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The certification is granted to Hovione's four manufacturing sites for the third consecutive year.