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Solux
Corporation is an International Pharmaceutical Company with the focus on
innovative development of generic Active Pharmaceutical Ingredients
(APIs) for oncology and acute-care hospital market. Our production of
generic APIs is based on the unique internationally patented or
patent-pending technologies which allow for a significant increase in
yield and a remarkable enhancement in purity and stability of our
products.
The
key APIs distributed by Solux Corporation throughout the World (the
anthracylcin-derived doxorubicin, epirubicin and idarubicin) are
manufactured by a manufacturing site Synbias
Pharma Ltd.,
in Donetsk, Ukraine. Solux Corporation is
an
exclusive World distributor for Synbias Pharma Ltd.,
which production technology is based on the intellectual property that
belongs to Solux Corporation. The Synbias Pharma facilities have
successfully passed both European Union and the US Food and Drug Administration
inspections, and they are certified as fully compliant with cGMP.
Please click to view the EU
cGMP Certificate and the US
FDA cGMP Certificate.
Solux
Corporation is proud to announce that in May of 2006 the US Patent and
Trademark Office issued the US
Patent 7,053,191 describing a novel idarubicin production method.
This particular invention has also received corresponding patents in China
(CN100379749C), Russia
(2336277), and India
(224413), with multiple patent pending applications in European Union.
Solux Corporation also received a US Patent 7,485,707 (link http://www.freepatentsonline.com/7485707.html ) (February
2009) describing a novel epirubicin crystalline polymorph with
significantly improved stability characteristics. Both patents having
priority date of 2004. This invention has also received corresponding
patents in China (CN100412084C) and Russia
(341530), with multiple patent pending application in European Union and India.
Another patent successfully issued by the US PTO to Solux Corporation is US
Patent 7,388,083 B2 (link http://www.freepatentsonline.com/7388083.html
), describing novel modifications of the anthracycline molecules
applicable to our proprietary epirubicin production technology.
Corresponding patent applications are pending in China, Russia,
India and multiple
countries of European Union. In all, Solux Corporation is currently
prosecuting seven (7) patent applications with corresponding PCT
application throughout the World.
Another
great achievement of Solux Corporation is that in December of 2006 the US
FDA approved the idarubicin hydrochloride injectable form, based on
Synbias’ API, for production and sale in the United
States. Since then, multiple global generic
manufacturers have had their ANDAs approved by the US FDA for production
of injectable formulations of Epirubicin, Idarubicin and Doxorubicin in
the United States.
However, the top achievement of Solux Corporation is that its work with
the United States Pharmacopoeia in 2009 resulted in our Epirubicin
becoming a USP standard. This confirms the superiority of our
manufacturing process and our APIs quality to the ones manufactured by
our competitors.
An
integral part of Solux Corporation success is its relationship with Biolik
biopharmaceutical company. This company specializes on production of
biologic medication, vaccines, anti-sera, and injectable final dosage
forms. Biolik facilities make our company exceptionally competitive in
all spheres of pharmaceutical manufacturing with strong expectations for
growth opportunities in the future. Solux Corporation currently
introduced an inactivated Hepatitis A vaccine to the Biolik’s portfolio.
This vaccine is currently undergoing clinical trial in Ukraine.
Over
the years, Solux Corporation has built an impressive network of customers
and partners throughout the world generic dosage forms manufacturers.
Current customers of Solux Corporation are a geographically diverse group
of pharmaceutical companies located in Western and Eastern Europe, Russia,
India, Australia, New
Zealand, Taiwan,
South Korea, Japan, Argentina,
Mexico, Uruguay, Canada
and United States.
Customer care continues to be the highest priority in our daily
operations.
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