Full Description

Caraco Pharmaceutical Laboratories, Ltd. (Caraco) is engaged in the business of developing, manufacturing, marketing and distributing generic and private-label pharmaceuticals to wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers, throughout the United States and Puerto Rico. During the fiscal year ended March 31, 2009 (fiscal 2009), Caraco received United States Food and Drug Administration (FDA) approval for eight abbreviated new drug applications (ANDAs) relating to three products. It had filed 10 ANDAs relating to nine products with the FDA during fiscal 2009. This brings Caraco’s total number of ANDAs pending approval by the FDA to 29 (including four tentative approvals) relating to 25 products as of March 31, 2009.

As of March 31, 2009, the Company’s product portfolio included 63 prescription products in 144 strengths delivered in various package sizes. It had submitted 71 ANDAs to the FDA for approval as of March 31, 2009, including 10 filed during fiscal 2009, which includes three products with multiple ANDAs. Of these 71 ANDAs filed, the FDA had approved 42 through March 31, 2009. Accordingly, the Company has 29 pending ANDAs (including four tentative approvals) relating to 25 products. The Company purchase 27 active pharmaceutical ingredients from Sun Pharmaceutical Industries Limited (Sun Pharma) and 63 active pharmaceutical ingredients from other third parties. During fiscal 2009, the Company’s three largest customers, Amerisource-Bergen Corporation, McKesson Corporation and Cardinal Health, accounted for approximately 9%, 16% and 20%, respectively, of the Company’s total net sales.