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Abstral® Receives Japan’s MHLW Approval


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Recipharm Stockholm has announced that the company was informed on September 20, 2013 by the R&D-based pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (Tokyo, Japan, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) that Abstral® sublingual tablet (nonproprietary name: fentanyl citrate; referred to below as “Abstral®”), has been approved for manufacturing and marketing by Japan's Ministry of Health, Labour and Welfare(MHLW).

The approval allows Recipharm to carry out commercial scale manufacturing and packaging of Abstral® for supply to the Japanese market through Kyowa Hakko Kirin.

The drug product, Abstral® is a novel, highly potent, rapid disintegration, sublingual (under the tongue) formulation of fentanyl citrate.

This well-established opioid is used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients that are already in receipt of opioid analgesics for cancer pain.

Japanese regulatory agency assessed Recipharm’s suitability through detailed analysis of the company’s history, capabilities, proven track record and the reliability of the supply chain set to take the product through to Japan, together with a thorough review of all clinical data and product documentation.

Recipharm will compress and formulate Abstral® in tablet dosage at its manufacturing site in Årsta, with all packaging performed at the company’s Jordbro complex. Quality control will be initiated in laboratories located in central Stockholm.

Thomas Beck, Director of Quality and Qualified Person at Recipharm Stockholm commented: “We are delighted to receive Japan’s MHLW approval to carry out a combination of both the manufacturing and the packaging of such a product, for onward supply to the Japanese market. Indeed, we are pleased, both because securing such authorization from a regulatory body outside of the EU is an extremely complicated process, especially in the case of Japan, and due to the fact that Abstral® is a highly innovative drug that enables fast relief of pain endured by patients undergoing cancer treatment.”

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