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Ashland Opens Excipient Facility in China

Now manufactures its major brands of excipients in Nanjing to better serve China’s burgeoning pharma industry

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Ashland has opened a new pharmaceutical excipient facility in Nanjing, China. Demand for polymer excipients, the substances formulated alongside the active ingredients of medications, is rising in China as the country’s pharmaceutical industry moves to modernize oral drug manufacturing and comply with new quality standards set forth in the 2015 edition of the Chinese Pharmacopoeia.

“Opening a world-class excipient facility in Nanjing is a testament to our willingness to partner with industry in China and to support the integrity and usability of pharmaceuticals produced in a country that is rapidly modernizing its healthcare infrastructure,” said William Wulfsohn, chairman and chief executive officer, Ashland.

William Zhao, general manager of specialty ingredients, greater China, said, “Opening a facility in Nanjing to manufacture the world’s most respected brands of polymer excipients within ‘tight’ world-class specifications is a vote of Ashland’s long-term confidence in the Chinese pharmaceutical industry,” he said. “Making a commitment to the Chinese market with a state-of-the-art facility, Ashland may now supply highly functional excipient technologies to manufacturers of oral pharmaceuticals and provide tailor-made formulation solutions that enable the delivery of vital health care to everyone in China.”

Among the cellulose-based excipients, Ashland will make available to China’s markets include those sold under the Klucel HPC, Benecel HPMC, Blanose CMC and Aqualon EMC trade names. The company also will make available a series of PVP-based polymer excipients, including Plasdone PVP and Polyplasdone PVPP polymers. All of these products are sold with a Registered Pharmaceutical Excipient Certificate, as required by the China Food & Drug Administration.

Alongside Ashland’s first ever pharmaceutical excipient production facility in China is an advanced quality control laboratory that contains equipment to measure and analyze products throughout the production process, including Thermal Fourier transform infrared spectrometers, Agilent liquid chromatography systems, and PE ICP optical emission spectrometers. The quality control system design and advanced analytical equipment allow Ashland to test all excipient products in accordance with Chinese Pharmacopoeia quality standards.

“Ashland has designed the excipient production facility in Nanjing to meet pharmaceutical excipient GMP standards, and that high level of manufacturing integrity is evident in outstanding product quality testing results,” said Mr. Zhao. “Moreover, our machines for each processing stage, including screening, grinding and packaging, are all global leading brands, and further support the manufacture of products that meet the same high standards as our world-class facilities outside of China.”

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