PORTAGE, Ind., July 6 /PRNewswire/ — MonoSol Rx announced today that it had completed the registration of both its Portage Indiana manufacturing facility as well as its Kingsport Tennessee development facility with the U.S. Drug Enforcement Administration (DEA) to handle controlled substances. The Company’s development facility has been registered for schedules II-V; the Company’s manufacturing facility has been registered for schedules III-V controlled substances.
These registrations complement other developments in the Company’s infrastructure including the bringing of packaging in-house as well as the inauguration of the Company’s analytical capabilities. These registrations will allow the Company to scale up active projects dealing with controlled substances.
Debra Belmonte, DEA Coordinator, commented: “The Portage manufacturing facility provides security for all controlled substances on the premises and our documentation processes are appropriate for registration requirements and ongoing compliance. The support and knowledge of everyone at MonoSol Rx was vital to our success in obtaining DEA registrations.” Ms. Belmonte joined MonoSol Rx in March 2006 from Morton Grove Pharmaceuticals.
About MonoSol Rx LLC
MonoSol Rx is a leading drug delivery company that uses film as a fast-dissolve oral drug delivery platform. MonoSol Rx LLC’s manufacturing facility is located in Portage, Indiana. MonoSol Rx previously acquired substantially all of the assets of Kosmos Pharma, including its extensive oral film intellectual property portfolio. MonoSol Rx’s film oral dosage form looks like a postage stamp and dissolves readily on the tongue to deliver drugs to a patient, replacing the use of conventional tablets and capsules. MonoSol Rx currently markets a variety of products together with its marketing partners.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide MonoSol Rx’s current expectations or forecasts of future events. These may include statements regarding the expected filing date of the sNDA and ANDA drug submissions for various products and the related anticipated date of FDA approvals, anticipated scientific progress on MonoSol Rx’s research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for the company’s products or product candidates, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. MonoSol Rx’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing MonoSol Rx. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, MonoSol Rx does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.