Hovione - Sites and cGMP Facilities

Sites and cGMP Facilities

Hovione has more than 530m3 of flexible production capacity with vessels ranging in size from 20 to 16,000 liters.

Flexible cGMP manufacturing capacity

Hovione has more than 530 cubic meters of production capacity in three FDA inspected sites: Portugal (Loures), China (Macau) and the USA (East Windsor, New Jersey). Five decades of focus in research and manufacturing activities in APIs explain the depth and breadth of available expertises, capabilities and experience.

We are dedicated to the manufacture of pharmaceutical fine chemicals complying with cGMP and regulatory filings. 95% of our sales are final APIs.

We are specialists in pharmaceutical chemistry and see ourselves as generalists in fine chemicals. Whatever the project requires – if it fits our strategy – we will perform every chemistry, make available any condition and will implement whatever engineering solution the process requires.

Our facilities suit every scale across our offering
– from phase I to compliant routine manufacture – and are constantly being adapted to suit projects.

Robust and mature procedures regulate the finer points of our activities:

– Phase appropriate GMP standards
– Policy on IP use and ownership, and patent assignment
– Tech transfer from customer to Hovione, from R&D to a validated routine
production environment and from site to site.
– Project management follows a defined template

Global production facilities:

•	Materials of construction range from glass lined, halar coated, TeflonTM, MonelTM, HastelloyTM and various types of stainless steel

•	Qualified clean rooms are used whenever solids or wet cakes are handled n Class 100,000 or better clean rooms for all finished product packing n State-of-the-art cGMP spray drying facilities, including large scale injectable grade capabilities and small volume sterile API

•	High potency category 3 compounds manufacturing facilities

•	Multiple vessel reactor trains operating at -90°C address process needs

•	High pressure hydrogenations to 100 bar, including a Buss loop reactor

•	Routine handling of HF at large-scale

•	DCS automated plants and electronic batch records in operation for over 10 years

•	24/7 piloting and manufacturing, with QC support

Investment in advanced technologies
Hovione’s commitment to modern and well-maintained equipment and new technologies has always been apparent to any visitor to our sites. Every year significant capital expenditure ensures that our GMP is current and our technologies state-of-the-art. Ask us about our use of PAT to define “design space” and how it is used in our labs and in our validated production lines. Come and find out how our Particle Design technologies can help improve the bioavailability or the stability of your drug product.

Highly qualified and well-trained people

Reliability and consistency are the result of well trained and motivated staff. At Hovione, we make sure this is routine, not a matter of luck.

Nothing we have achieved would have been possible without our people. Auditors routinely report that they find our staff technically proficient and enthusiastic. Employee turnover is less than 4% per year.

We are committed to the professional development of our staff at all levels and invest accordingly. Employees across all geographic locations are united by a common approach to projects. Our "one company, multiple locations" culture has three distinctive attributes: process chemistry skills within an industrial environment, a pharmaceutical culture and a rigorous quality mind-set.