BOCA RATON, Fla., Jan. 7 /PRNewswire/ -- Breckenridge announced today that it has entered into an agreement with Helm AG to develop and manufacture a generic tablet ANDA product. Breckenridge expects to file an ANDA with the FDA in January 2008. Upon approval by the FDA, Helm AG will supply and Breckenridge will market and distribute the product on an exclusive basis.
Under terms of the agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Administration (FDA) for the product which as been developed by Helm AG. The product currently shows U.S. sales of approximately $800 million.
Breckenridge Pharmaceutical is a privately held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of ValuBrand(TM) and 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 100 products, more than 150 sku's, in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions and Topical preparations. http://www.bpirx.com
About Helm AG:
Helm AG is an international chemical and pharmaceutical organization and a multifunctional marketing group which operates as a link between producers and industrial end users.
With branch offices and participations in 32 countries HELM provides a
wide range of services including marketing, distribution, production,
logistics, generic development and registration. http://www.helmag.com
For Further Information, please contact:
Breckenridge Pharmaceutical Helm New York, Inc.
Larry Lapila, Vice President Boy Ehlers, Vice President
Business Development Pharmaceutical Division
TEL: 860-828-8140 TEL: 732-981-1160
FAX: 860-828-8142 FAX: 732-981-0965
|SOURCE Breckenridge Pharmaceutical|
Copyright©2008 PR Newswire.
All rights reserved