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Banner Pharmacaps Receives FDA Approval For Nimodipine Softgel Capsules

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Jan 2008 - 5:00 PDT

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Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, announced that the US Food & Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Nimodipine 30 mg soft gelatin capsules.

Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop® 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles.

Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.

About Banner Pharmacaps Inc.

Banner Pharmacaps Inc. is a global drug delivery and specialty pharmaceutical company which is developing a proprietary portfolio of unique products and oral dosage forms that include the enhanced technologies of enteric and controlled release softgels, as well as Soflet® Gelcaps. Headquartered in High Point, North Carolina, Banner is committed to the research, development, and manufacture of quality healthcare products to serve our global community.

Banner Pharmacaps Inc.

The parent company of Banner is VION N.V., an international food group that produces high-quality foodstuffs and ingredients for humans and animals. VION has annual sales of €7.4 Billion, with 15,150 employees worldwide. The head office of VION is in Son en Breugel, The Netherlands.

About Heritage Pharmaceuticals

Heritage Pharmaceuticals Inc. is an emerging generic pharmaceutical company engaged in the acquisition, licensing, development, marketing, sale and distribution of generic pharmaceutical products for the global prescription drug markets. Heritage launched its U.S. label in 2006 and currently markets 4 products over 15 SKU's. The Company will continue to introduce its acquired multi-source generic product line during 2008 following its tradition of premier quality, value and service in generics.

Heritage Pharmaceuticals




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