After receiving approval from the Food and Drug Administration of United States of America (US FDA), Claris Lifesciences has announced its strategy to sell on its own in United States (US). With this development, the company, will no longer pursue its strategy to supply to the United States through any of its partners including Pfizer, West- Ward and Sagent.
The company earlier also was selling in the US, at the time when it had not entered with other companies, through its wholly owned subsidiary, Claris Lifesciences Inc, and had developed adequate capabilities to sell on its own. Further, the company expects this strategy to be beneficial for the growth of the company as the pricing under the direct sales would be better than the supply through partners.
Back, in 2010, the USFDA issued a warning to the company over quality issues and banned the company from selling its products in the US until it complied with the issues. However, after inspecting Claris facility in February, USFDA subsequently lifted the ban earlier this week.
Meanwhile, Claris, in 2009 entered into an agreement with Pfizer to gain access to markets in North America, Europe and Australia. The deal allowed Multinational drug-maker Pfizer Inc to sell 15 off-patent parenteral products made by Claris in the Western markets under its own brand name.
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