Commencing January of 2008, the SFDA implemented stricter pharmaceutical GMP inspection standards designed to intensify supervision of drug producers and ensure drug quality. The new inspection standards include 259 articles, up from 225 articles in the previous standards, covering areas such as the sourcing of raw materials, manufacturing processes, self-inspection processes at each stage of production and transportation. China Biologic's newly constructed facility with 700 tons of annual production capacity for plasma-based products was certified to be in compliance with the new standards. The renewed GMP Certification replaces the current GMP certification for the production facility, which was renewed in 2004. The GMP certification is valid for five years following the date of issuance.
The plasma-based industry has been immune from the impact of the ongoing global financial crisis as the demand for the products has out-paced supply. As a result, the Company's selling price, cost of revenue and operating expenses during 2008 were not impacted by the global financial turmoil.
Currently, China Biologic is the only approved manufacturer of plasma-based biopharmaceuticals in Shandong Province, which has a population of 93 million. China Biologic currently produces about 200 tons of plasma-based products per year and has 700 tons of annual production capacity. The Company is pursuing an aggressive acquisition strategy aimed at becoming the largest non-state-owned producer of plasma-based products in China.
On September 26, 2008, the Company agreed to acquire a 90% controlling
interest in Chongqing Dalin Biologic Technologies Co., Ltd. ("Dalin"). Dalin
owns 54% of the equity interest in Qianfeng Biological Products Co., Ltd.
("Qianfeng"), one of the largest plasma-based biopharmaceutical companies in
China, located in Guiyang, Guizhou Province. The acquisition will
|SOURCE China Biologic Products, Inc.|
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