TOKYO, Japan – The Sanda factory of R-Tech Ueno, Ltd. has received notice from the FDA that its facility has been classified as acceptable for the production of pharmaceuticals by meeting compliance with U.S. cGMP regulations. The FDA inspected the Sanda factory in December 2009. By passing this inspection, Rescula Eye Drops (unoprostone isopropyl eye drops) manufactured at this factory may be exported for sale in the United States.
R-Tech Ueno announced the signing of a contract with Sucampo Pharmaceuticals, Inc. for the sale of Rescula Eye Drops in the United States and Canada in a press release dated April 24, 2009. Under this agreement, Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, is granted the right to sell Rescula Eye Drops in the United States and Canada for the treatment of glaucoma and ocular hypertension and is licensed to use Rescula’s patent protection to develop new uses. R-Tech Ueno has the exclusive right to supply the eye drops to Sucampo Pharma Americas.
Passing this inspection will not affect the performance of R-Tech Ueno at this time. However, it allows the company to manufacture and export this pharmaceutical to the United States, which is one of the world’s largest markets for pharmaceuticals. R-Tech Ueno believes that successfully passing this inspection will lead directly to future growth in R-Tech Ueno’s contract manufacturing services.
“We will aggressively pursue opportunities to manufacture pharmaceuticals and investigational drugs for customers in the United States. We also plan to offer R&D support services for U.S. pharmaceutical companies,” stated R-Tech Ueno President Yukihiko Mashima. “In addition, we can provide customers in Japan with high-quality services such as OEM production and technical assistance for their research programs. I believe these capabilities will allow us to capture more outsourcing contracts and broaden the scope of our business operations.”