Manufacturing
In 2008, Orient Pharma invested NT$800 million in a new plant located in Yunlin County’s Huwei Township. The Huwei plant takes up a total area of 15,300 square meters and the main building is comprised of three stories. The new plant is designed to conform to the standards set forth by the U.S. FDA (U.S. Food and Drug Administration), and apply the product certification to U.S. FDA, European PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme) as well as certification bodies in Japan. The plant is conveniently located at about an hour and half from Taipei via the high speed rail. The groundbreaking ceremony took place on Dec. 7, 2008 and construction is slated for completion in 2010. The plant is scheduled to start producing its own R&D drugs for bioavailability, bioequivalence and clinical trials in the second quarter of 2010.
Drugs manufactured in the new plant include generic, controlled-release, and internationally patented new forms, combinations and indications.
In order to carry out large-scale production while lowering costs and increasing competitiveness, Orient Pharma will import branded drug manufacturing equipment, including high-sheer mixers, granulators, fluid bed dryers, film coating machines, and tablet compressing machines. Orient Pharma also plans to partner with Japanese machinery plants to manufacture the company’s own designs of three-stage hot-melt capsule filling equipment for use in the production of new drug forms or combinations.
To ensure product quality and comply with U.S., European, and Japanese pharmaceutical standards, Orient Pharma will hire quality control personnel and import state-of-the-art drug analysis equipment. The subsidiary will also train its staff on international regulations and enlist the services of foreign consultants.