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50 Years Making Generic
APIs
Generic APIs have been a core part of Hovione's business
for the past 49 years. Over that time we launched more than 45 generic APIs
to the most demanding customers in the United States, Europe and Japan and
has gained a reputation in the Industry for superior quality, reliability
and customer service. As a Company, we have always aimed to do well what
is difficult and our steady and healthy evolution has been driven by a constant
seeking of greater technological challenges. Our products have been used
in the most challenging drug product formulations from large volume parenterals
to dry powder inhalation.
A continuous development of technological
expertise
In the 60’s, Hovione began developing strains
by fermentation, for the production of antibiotics, synthesizing and commercializing
small quantities at pilot scale.
In the 70’s, research efforts were directed towards chemical synthesis,
primarily in the area of anti-inflammatory corticosteroids.
An independent 18 consecutive step process was developed and industrialized
to produce betamethasone and its derivatives, with Japan as its primary
market.
In the 80’s, Hovione’s plant was inspected and approved by the
FDA and soon became the largest supplier of doxycycline to the USA.
Hovione’s dexamethasone dipropionate also became Japan’s top
selling topical anti-inflammatory corticosteroid. An extensive portfolio
of semi-synthetic antibiotics and corticosteroids for topical and inhalation
application were also developed and successfully commercialized, establishing
Hovione as a leading player in the international generics market.
In the 90’s, Hovione initiated the production of injectable grade
APIs, investing in facilities and know how to enter this specialized area.
Hovione launched Iopamidol and Iohexol, becoming Japan’s primary supplier
in contrast media agents.
Since 2000, Hovione further diversified its portfolio of generic products,
developing knowledge in the chemistry of Macrolides and becoming the first
supplier to obtain the Certificate of Suitability for Roxithromycin. More
recently, we installed a new cGMP Spray Drying facility and have been developing
our know how in the area of Particle Design, building on our accumulated
expertise in crystallization, micronization, jet-milling and freeze drying.
This expertise gives us greater control in optimizing particle characteristics
and enables us to provide customized solutions to address the special requirements
of new drug delivery systems. In this area, Hovione is now developing what
we call “Super Generics”.
Our focus is on value generics, which means we concentrate on developing
difficult and sophisticated products: complex molecules, niche applications,
supergenerics and APIs which demand exceptional quality standards, advanced
production technologies or that present other challenges and barriers to
market entry.
Our proven track record in compliance combined with our continued investment
in advanced technologies means we are well positioned to serve you as a
supplier of unique solutions.
Our 15-years experience in the exclusive APIs business complements our generic
offering. It makes us a truly service-oriented company with experienced
staff who understand customer's needs and a project's critical path.
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