Business Daily from THE HINDU group of publications Sunday, Aug 27, 2006 |
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Corporate
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Regulatory Bodies & Rulings Akorn-Strides files 10th ANDA Our Bureau
Bangalore , Aug. 26 Strides Arcolab said its US joint venture Akorn-Strides LLC has submitted its tenth ANDA (abbreviated new drug application) with the Office of Generic Drugs. The first filing was made in April this year, according to a release. The release did not give details of the drugs. Akorn manufactures sterile speciality pharmaceuticals and markets hospital and ophthalmic pharmaceuticals. The 50:50 joint venture has identified 20 generic injectables in the first phase. In the venture formed in September 2004, Strides develops products for the US market and Akorn takes care of regulatory aspects, filings and exclusive marketing of USFDA-approved drugs in the US. The Akorn President and CEO, Mr Arthur S. Przybyl, said, "The submission of the tenth ANDA filing represents a significant milestone. Strides is performing its responsibilities to the joint venture ahead of schedule." Expressing happiness at the pace of filings, the Strides Executive Vice-Chairman and Managing Director, Mr Arun Kumar, said, "We are confident of... providing a strong pipeline and supplies to convert Akorn-Strides into a significant hospital player in the US." Akorn is required to achieve a minimum market share in the US for each drug and get a commission on the sales.
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