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Ranbaxy To Market Zonisamide Capsules In The US |
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10 Jun 2006 |
GURGAON, India | Jun 09, 2006 | Ranbaxy Laboratories Limited (RLL) announced today that the Company plans to market Zonisamide Capsules for the treatment of epilepsy in the U.S. market through a strategic partnership with Invagen Pharmaceuticals Inc. (Invagen) of Hauppauge, New York. Invagen has received the U.S. FDA approval for bio-equivalency and, therefore a therapeutically equivalent Zonisamide to the listed drug Zonegran(tm) Capsules, 25mg, 50mg, and 100mg respectively.
The agreement with Invagen provides for products to be developed and submitted to the U.S. FDA for approval, and for manufacturing in Invagen's U.S-based manufacturing facility. Ranbaxy Pharmaceuticals Inc. (RPI) will then commercialize the product under the Ranbaxy label to all classes of trade. Zonisamide Capsules have total annualized sales of $170.3 Mn ($US, IMS - MAT: March 2006).
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
"The addition of Zonisamide Capsules to our product mix through an alliance with Invagen reinforces our strategy to use inorganic means to grow our product pipeline, as well. Such partnerships with companies like Invagen, who have capabilities and competencies to develop bioequivalent generic products for the marketplace, are naturally beneficial to both organizations, while having a positive economic impact on the U.S. healthcare system," according to Atul Malhotra, President of Ranbaxy, Inc.
Jim Meehan, Vice President of sales and marketing at RPI offered the following comments: "We anticipate product availability to all classes of trade no later then the end of July once sufficient inventories are available to meet the needs of our customers. We are also pleased to see our partnership with Invagen come to fruition, and anticipate additional products materializing to fuel our market growth into the future."
Ranbaxy Pharmaceuticals Inc. (RPI), based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 8 countries.
* Zonegran(tm) is a registered trademark of Dainippon Pharmaceutical USA Corporation.
SOURCE: Ranbaxy Laboratories Limited |
