BOCA RATON, Fla., Aug. 17 /PRNewswire/ -- Breckenridge announced today that it has entered into an agreement with Orit Laboratories to market the Company's Abbreviated New Drug Application (ANDA) for Ergocalciferol Capsules, USP, 50,000 USP Units (1.25mg), (Vitamin D), the generic version of Drisdol(R) by Sanofi-aventis. The product was approved by the U.S. Food and Drug Administration (FDA) on May 20, 2009. Under the terms of this agreement the product will be supplied by Orit Laboratories, and marketed and distributed by Breckenridge Pharmaceutical, Inc. on an exclusive basis in the U.S. The companies plan to start shipping immediately.
About Orit Laboratories:
Orit Laboratories specializes in the development of specialty generic pharmaceutical prescription products. The company focuses on the development of solid, liquid, soft gelatin capsule, modified release, and orally disintegrating dosage formulations using proprietary Drug Delivery Platforms. Orit Laboratories operates an FDA registered cGMP facility in West Caldwell, New Jersey that is approximately 10,000 sq. ft. The company is capable of pilot scale production, and their analytical laboratory operates under cGMP & cGLP. Orit has capabilities of Regulatory filing with the US Food and Drug Administration (FDA).
Breckenridge Pharmaceutical
