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
  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
  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

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 USChinaIreland, 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. 

Also in the Press Room

See All

Aim to accelerate drug development and production with new technologies. By: Charlie Sternberg Hovione, an international integrated pharmaceutical development and manufacturing organization, and Microinnova Engineering, a leader in continuous process intensification, have partnered to advance the development of multi-purpose, plug-and-play modular equipment for flow chemistry. The companies will work together to test Microinnova’s modular manufacturing equipment, which is designed to offer greater flexibility, easier scalability, enhanced efficiency, and sustainable practices in active ingredient production, in an industrial setting. Together, the companies aim to accelerate process development, facilitate a seamless transition from lab to large-scale manufacturing, and ultimately reduce the time to market for pharmaceutical customers. “This collaboration with Microinnova underscores Hovione’s commitment to innovation in pharmaceutical manufacturing, with flow chemistry playing an important role in our long-term drug substance strategy,” said Dr. Jean-Luc Herbeaux, CEO of Hovione. “This partnership will allow us to shape and validate emerging continuous manufacturing technologies, which can potentially accelerate drug development and production.” Dr. Dirk Kirschneck, Founder and Strategic Director at Microinnova, added, “This partnership reflects our shared vision to deliver modular manufacturing technologies that support pharmaceutical innovation and manufacturing excellence. We are proud to join forces with Hovione to showcase the capabilities of our next-generation modular equipment in a dynamic CDMO environment, demonstrating its versatility for multi-purpose manufacturing.”   Read the full article on ContractPharma.com  

Press Clipping

Hovione, Microinnova Partner to Test Modular Manufacturing Equipment

Sep 24, 2025

The global inhalation contract development and manufacturing organization (CDMO) market is projected to grow from USD 9.13 billion in 2025 to USD 16.68 billion by 2035, reflecting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases, advancements in inhalation drug delivery technologies, and the rising demand for outsourced manufacturing services in the pharmaceutical industry. The inhalation CDMO market has emerged as a pivotal segment in the pharmaceutical contract development and manufacturing industry. With a rising demand for inhaled therapies for conditions like asthma, COPD, and cystic fibrosis, companies are increasingly outsourcing drug development and production to specialized partners. Inhalation CDMO services cater to both large pharmaceutical corporations and small biotech firms, offering expertise in formulation, device compatibility, regulatory support, and scale-up manufacturing. This market is gaining traction due to the complexity of inhalation drug delivery, which often requires niche technical capabilities and specialized equipment. Outsourcing to an inhalation CDMO allows drug developers to reduce time-to-market while ensuring quality and compliance with global standards. (...) Top Companies Several players dominate the inhalation CDMO market through technological expertise, global reach, and service portfolio diversity: (...) Hovione – Offers particle engineering and inhalation development, with a focus on dry powder inhalers. (...) These companies are continually investing in facilities, talent, and technology to meet evolving customer needs in the inhalation CDMO market.   Read the full article on Pharmiweb.com        

Press Clipping

Inhalation CDMO Market Growth Analysis & Forecast 2025 to 2035

Jun 25, 2025