China's Zhejiang Huahai Pharma Receives US Regulatory Approval for Its Cardiovascular Generic Drug
Tang Shihua
/SOURCE : Yicai
China's Zhejiang Huahai Pharma Receives US Regulatory Approval for Its Cardiovascular Generic Drug

(Yicai Global) May 11 -- China's Zhejiang Huahai Pharmaceutical Co. has obtained the approval of abbreviated new drug application, or ANDA, from the US Food and Drug Administration for its generic drug for the treatment of cardiovascular disease. The approval qualifies the Chinese company to sell the product in the US market, it said.

The company has invested nearly CNY14 million (USD2.2 million) in the research and development of the drug, said a company statement yesterday.

The generic drug, known as clopidogrel tablet, is mainly used for the prevention and treatment of myocardial infarction, ischemic cerebral thrombosis, thromboangiitis obliterans, and complications caused by atherosis and thromboembolism.

The clopidogrel tablet was developed by French pharma firm Sanofi SA and entered the US market in 1997. Among the current main manufacturers of this drug in the US are Canadian Apotex Inc. and Indian Aurobindo Pharma Ltd. The sales of the drug reached USD111 million in the US last year, the statement said, citing publicly available information.

Zhejiang Huahai Pharmaceutical has been actively engaging in the development of generic drugs and also received the approval of ANDA from the FDA for its anti-hypertension generic drug last month.

Editor: Mevlut Katik

Follow Yicai Global on
Keywords: US FDA , Medicine , Cardiovascular Disease , Huahai Pharmaceutical