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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 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.
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Primary
Service Lines
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Inhalation |
Particle Design |
Generic Products |
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Route
discovery |
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Process
development |
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Proven
acceptable range (PAR) studies |
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Process
engineering and industrialization |
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Clinical
quantities |
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Lab,
pilot and commercial scale production |
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Pre-clinical,
clinical and commercial supply |
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Plant
engineering |
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Formulation
development |
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Device development |
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Specialist QC
support |
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Cascade impactor
studies |
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Excipient sourcing
and characterization |
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Particle morphology
analysis |
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Lab and pilot
scale |
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Pre-clinical
and clinical supply |
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Spray drying |
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Freeze drying |
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Spray congealing |
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Micronization |
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Jet milling |
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Controlled crystallization |
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Cocrystallization |
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Encapsulation/particle
coatings |
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Sonocrystallization |
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Lab, pilot and
commercial scale |
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Pre-clinical,
clinical and commercial supply |
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Value generics |
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Exclusive generic
APIs |
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Improved formulations |
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Patent extensions |
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Tetracyclines,
macrolides, mectins |
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Corticosteroids |
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Contrast agents |
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Full service |
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Supporting services
| Regulatory Support |
GMP and HSE Compliance |
Technology Transfer |
Strategic Sourcing |
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Comprehensive
analytical method development and validation
Process control
Product, intermediate and raw materials release |
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Particle analysis |
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Full QC stability
(ICH) |
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Batch release |
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Filings at medicine
agencies (DMF/CMC, FDA/EMEA,etc.) |
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ICH Q7a, ISO
14000 |
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Pre-approval
inspections |
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Audits |
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Validation |
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Process documentation |
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Compliance |
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Comprehensive
quality, GMP and HSE programs |
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Method transfer
from customer to manufacturer |
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Method transfer
from R&D to manufacturing |
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Method transfer
between manufacturing sites |
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Inter-laboratory
analytical method transfer |
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30-year presence
in China |
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Established
relationships with over 100 suppliers in Asia |
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Audited suppliers
for all critical raw material |
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Experienced
team of 10 people in global chemical purchasing |
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Due
Diligence Issues 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 50 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 1300m3 of installed
reaction capacity, in five sites. |
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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 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. |
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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 2009. 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 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. |
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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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