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Welcome
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
600 people worldwide and its 3 sites have a total reactor capacity of 530m3,
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.
Due Diligence Issues
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SOLID FOUNDATIONS |
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Profitability: Founded in 1959 the company has yielded positive
operating profits every year. |
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Labour relations: The company has never lost a day of work to labour
unrest. |
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Shareholding stability: Hovione is an independent manufacturer
unconnected with any pharmaceutical company and control has remained
essentially unchanged for 45 years. |
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CAPACITY |
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Hovione has capacity installed to produce from kilos to tonnes of
injectable grade APIs, including sterile powder at large scale. |
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Hovione has a total of 530m3 of installed reaction capacity, in two
sites, both FDA approved, and Macau is ISO9001:2000 certified. |
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Since 1991, and every year, no less than $5million is invested in
new plant and equipment. |
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TRACK-RECORD AT FDA AND AT OTHER HEALTH AUTHORITIES |
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Hovione has undergone no fewer than 14 FDA inspections over a
23-year period. Over that time, no warning letter has ever been
issued and, of the 10 Form 483s received, all were addressed
satisfactorily within 30 days. |
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Our
customers have never been the object of a re-call caused by our bulk
product. |
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Hovione has been regularly inspected by FDA for APIs since 1982; and
most recently in 2005. We currently supply APIs under NDA or DMF to
the USA for oral, topical, inhalation and injectable administration.
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We
have DMFs filed for APIs in every country of the world who has such
a system in place. |
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ENVIRONMENT |
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Hovione subscribes to Responsible CareŽ. 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. |
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Currently a Hovione director is also board member of the Portuguese
Chemical Association and has special responsibility for
environmental issues. |
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About us 
Corporate Responsibility
Corporate Responsibility
