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Hovione is an international group dedicated to the cGMP development and manufacture of APIs, serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. Specializing in complex chemistry and particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Our aim is to do well what is difficult, to give our customers what they can not find elsewhere.  

Aiming to provide superior customer service, we take full responsibility for all matters relating to the API from pre-IND to NDA and beyond, ensuring fast and successful product launches.


Hovione’s reputation as a reliable long-term supplier has been built by delivering robust solutions to our customers on time, every time. The continuity and consistency of the service we provide is based on two essential factors: focus and thoroughness.

Our specialist expertise in process chemistry enables us to address the complex issues associated with the development and manufacture of APIs and regulated intermediates. Our rigorous and systematic approach to project management is complemented by experienced staff with excellent technical and practical problem-solving skills. Together, these elements guarantee an unfailing and consistent quality of end-product and service.

Hovione focuses its activities on the development and production of small molecules for demanding customers in the most highly regulated markets. We have produced over 45 different APIs at a commercial scale, developed more than 100 chemical processes at industrial scale and have filings in every country that has a specific API filing requirement.

With worldwide yearly revenues of about US$100m, our main markets are North America (55% of sales), Europe (25%) and Japan (12%). Hovione employs 1000 people worldwide and its 5 sites have a total reactor capacity of 1300m3, ranging from lab to industrial ton scale.

Hovione business is 50% custom synthesis for large Pharma and Biotech companies, 50% generic products.
Our latest technologies in Particle Design and our new state-of-the-art cGMP Spray Drying installation enable us to provide our customers with solutions for Advanced APIs (aAPIs™), a step closer in the formulation pharma process.




 
 
 

Primary Service Lines

Exclusives Inhalation Particle Design Generic Products

Route discovery 
Process development
Proven acceptable range (PAR) studies
Process engineering and industrialization
Clinical quantities
Lab, pilot and commercial scale production
Pre-clinical, clinical and commercial supply
Plant engineering

Formulation development
Device development
Specialist QC support
Cascade impactor studies
Excipient sourcing and characterization
Particle morphology analysis
Lab and pilot scale
Pre-clinical and clinical supply

Spray drying
Freeze drying
Spray congealing
Micronization
Jet milling
Controlled crystallization
Cocrystallization
Encapsulation/particle coatings
Sonocrystallization
Lab, pilot and commercial scale
Pre-clinical, clinical and commercial supply

Value generics
Exclusive generic APIs
Improved formulations
Patent extensions
Tetracyclines, macrolides, mectins
Corticosteroids
Contrast agents
Full service


Supporting services

Regulatory Support GMP and HSE Compliance Technology Transfer Strategic Sourcing





Comprehensive analytical method development and validation
Process control
Product, intermediate and raw materials release
Particle analysis
Full QC stability (ICH)
Batch release
Filings at medicine agencies (DMF/CMC, FDA/EMEA,etc.)

ICH Q7a, ISO 14000
Pre-approval inspections
Audits
Validation
Process documentation
Compliance
Comprehensive quality, GMP and HSE programs

Method transfer from customer to manufacturer
Method transfer from R&D to manufacturing
Method transfer between manufacturing sites
Inter-laboratory analytical method transfer

30-year presence in China
Established relationships with over 100 suppliers in Asia
Audited suppliers for all critical raw material
Experienced team of 10 people in global chemical purchasing

 



Due Diligence Issues

SOLID FOUNDATIONS

Profitability: Founded in 1959 the company has yielded positive operating profits every year.
Labour relations: The company has never lost a day of work to labour unrest.
Shareholding stability: Hovione is an independent manufacturer unconnected with any pharmaceutical company and control has remained essentially unchanged for 50 years.
   

CAPACITY
Hovione has capacity installed to produce from kilos to tonnes of injectable grade APIs, including sterile powder at large scale.
Hovione has a total of 1300m3 of installed reaction capacity, in five sites.
Since 1991, and every year, no less than $5million is invested in new plant and equipment.
   

TRACK-RECORD AT FDA AND AT OTHER HEALTH AUTHORITIES
Hovione has undergone no fewer than 17 FDA inspections over a 27-year period. Over that time, no warning letter has ever been issued and, of the 11 Form 483s received, all were addressed satisfactorily within 30 days.
Our customers have never been the object of a re-call caused by our bulk product.
Hovione has been regularly inspected by FDA for APIs since 1982; and most recently in 2009. We currently supply APIs under NDA or DMF to the USA for oral, topical, inhalation and injectable administration.
We have DMFs filed for APIs in every country of the world who has such a system in place.
   

ENVIRONMENT
Hovione subscribes to Responsible Care®. Our efforts and significant investments in the protection of the environment have earned us the 1992 bi-annual EU and UN award for better environment in industry in the recovery of waste category. This was a pan-european award and the runner-ups included the likes of Solvay and Shell.
Currently a Hovione director is also board member of the Portuguese Chemical Association and has special responsibility for environmental issues.
   
   
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Sete Casas l 2674 - 506 Loures l Portugal | main. +351 21 982 9000 fax.+351 21 982 9388 |
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