PORTAGE, Ind., June 6 /PRNewswire/ — MonoSol Rx announces the inauguration of their pharmaceutical analytical laboratories at their Portage, IN site to support ongoing pharmaceutical drug development and production. The new analytical laboratory is part of a corporate initiative to vertically integrate all aspects of product development and manufacturing, including packaging, and position MonoSol Rx as the leading source for rapidly dissolving films in the drug delivery industry.
Dr. Pradeep Sanghvi, Vice President of Pharmaceutical Development commented, “The fully equipped analytical laboratories, along with our manufacturing and packaging capabilities, provide MonoSol Rx the necessary tools to be the leading provider of film based drug delivery systems. These modern cGMP laboratories, part of a 24,000 square feet expansion, are capable of supporting formulation R&D and process development as well as QC testing, ICH stability studies, raw material as well as finished product release testing.”
Each laboratory will house state-of-the-art analytical instrumentation and equipment. Data archival and retrieval will have built-in redundancy systems as well as remote storage and scalability to accommodate future expansion of analytical laboratories at all MonoSol Rx sites.
About MonoSol Rx
MonoSol Rx is a leading drug delivery company that uses film as a fast-dissolve oral drug delivery platform. MonoSol Rx’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.