PATTERSON, NY (April 12, 2004) – Prosolv SMCC, approved by the Japanese Ministry, Health and Welfare in November, is now available for use in pharmaceutical formulations in Japan, JRS Pharma said last week.Previous approvals were granted by the U.S. Food & Drug Administration and the European Union regulatory bodies, the company said.
The Japanese launch enables pharmaceutical companies to expand the development of global formulations using Prosolv SMCC without regulatory delay, the company said. Prosolv is a high-functionality excipient, an advanced new class of co-processed excipients that perform multiple functions simultaneously for rapid tablet formulation.Eric Smith, vice president marketing for JRS Pharma, said the company expects two Japanese product launches that utilize Prosolv within the next 12 months.
Kimura Sangyo is the JRS agent in Japan, the company said. JRS Pharma is a wholly owned subsidiary of Germany-based JRS Pharma GmbH & Co.
