BOCA RATON, Fla., Nov. 19, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Rabeprazole Sodium Delayed Release Tablets. The product is being manufactured and supplied by Rubicon Research Private Limited, and will be available in 20mg strengths and pack sizes of 30's, 90's and 500ct. Rabeprazole DR Tablets are AB rated to Aciphex®, which is indicated for the treatment, healing and maintenance of GERD in Adults and Adolescent Patients 12 Years of age and older and the healing of Duodenal Ulcers in Adults has annual sales of $128 million based on IMS Health sales data, as of September 2015. The product launch plans are being finalized and the first shipment will occur shortly.
Breckenridge Pharmaceutical, Inc., is a privately-held own label Distributor that performs pharmaceutical research and development as well as marketing and distribution in the U.S. The company markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: tablets, capsules, soft gel capsules, liquids, suspensions, and powders. www.bpirx.com
About Rubicon Research Private Limited.
"Rubicon is technology driven pharmaceutical product development company. Rubicon is engaged in research, development, and manufacturing of both OTC and Rx branded and specialty generic products. Rubicon has demonstrated excellence in product development across dosage forms such as Oral Solids, Oral Liquids and Topical formulations. Rubicon carries out Innovative Research programs that include development of differentiated products based on proprietary technology platforms such Orally Disintegrating Tablet Technology, Gastroretentive Solubilized Drug Delivery System and Extended Release Oral (Solid and Liquid) Systems. The technologies are all IP protected and Rubicon has numerous patents application and a few issued patents which gives freedom to operate to our partner companies. Rubicon has a state-of-art commercial manufacturing plant which has been successfully inspected by USFDA and UKMHRA. " For further information, please visit www.rubicon.co.in
ACIPHEX® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
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SOURCE Breckenridge Pharmaceutical, Inc.