Tianjin-based pharmaceutical company Tasly Group is investing $40 million to build a production and training center in Maryland, US, to help prepare for the entry of its Compound Danshen Dripping Pills (CDDP) into the American market, the company announced in Shanghai on Thursday.
The 430,000-square-foot facility is expected to be complete within a year and a half, and will serve as a base for further clinical trials of CDDP as well as its future production, packaging and warehousing.
CDDP is a TCM (traditional Chinese medicine) for treating coronary diseases. It started its US Food and Drug Administration (FDA) application in 1997 and successfully passed the Phase II clinical trial last year. If it passes the Phase III trials, it will be the first combination Chinese medicine – which means it includes both Western medicine and TCM – given the all clear for marketing in the US.
The company expects to put its star product on US store shelves as early as 2014, benefiting some 10 million patients, it said.
"Tasly Group aims to become an international company and help push forward TCM onto the global market," Tasly chairman Yan Xijun said.
While many TCM companies are busy applying for approvals from the European Union (EU), Tasly is focusing on FDA approval.
"FDA certification is even stricter than that of the EU, so if CDDP passes FDA tests, entry into the EU will be an easier process and the company will achieve its global goal," Guo Fanli, pharmaceutical researcher at the CIC industry research center, said on Thursday.
"Tasly's domestic test results show that CDDP is safe, so we expect it to pass the Phase III test. But if it fails, the company will have to turn its focus back to the domestic market," Guo said.
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