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news.GeoPharma has said that the FDA Office of Compliance has completed the assessment of its manufacturing facility, at Largo, Florida, which is dedicated to the production of Cephalosporin antibiotics.
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GeoPharma has also indicated that, based on the adequacy of its written response, it is acceptable to manufacture upon FDA approval of its Cephalexin ANDA.
Mihir Taneja, CEO of GeoPharma, said: “The approval of this facility has been long anticipated. We are so pleased to have finally gained the endorsement of our facility by the FDA and we look forward to the related Cephalexin ANDA approval during the fiscal year ending March 31, 2011.
“We have made dramatic in roads with regards to our relationships in these areas and believe the plant approval and pending ANDA approval will be beneficial to the future of the Company. In this morning’s conference call we will be discussing the company financials as well as the plant approval and other pertinent information related to our business.”
GeoPharma is a bio/pharma company with a diversified business model participating in pharmaceuticals, contract manufacturing, and medical devices. The pharmaceutical divisions specialize in the formulation of generic drugs for human and veterinary usage and the development of medical devices used by oncologists and other medical professionals. The manufacturing division manufactures and packages generic drugs, nutraceuticals, cosmetics, and functional food products for companies worldwide.