The Unique Source of High-Grade Generic Pharmaceuticals

Synbias Pharma Ltd.

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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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