Provepharm obtains European marketing authorization for its Methylthioninium Chloride Proveblue
The active principal Proveblue (TM) is the only methylene blue in the world that is compliant with the monograph of the European pharmacopoeia and to ICH Q3A standards on impurities in new active substances. It has a very high degree of purity and is virtually free of metallic contaminants such as heavy metals.
Securing European marketing approval is a major milestone for Provepharm in commercial development terms. It effectively gives the company access to the markets of all 27 European Union countries, as well as the three countries linked to the EU (Norway, Iceland and Liechtenstein). Furthermore, it will give a major boost to its plans for extending the product’s commercialization to the world market, as well as being a significant asset for developing other pharmaceutical applications.
Provepharm’s European Marketing Authorization Application (MAA) for Proveblue (TM) already prompted a leading Japanese pharmaceutical company to carry out a general audit, including the supply chain, and this company has just confirmed its wish to acquire exclusive rights to the product for the Japanese market. In the United States, where no marketing authorization has yet been granted for injectable products based on methylene blue, several candidates have already expressed an interest in Proveblue (TM).
Over and beyond these key markets, Provepharm has already made contact with several companies on other continents, which opens up the possibility of international coverage and confirms the potential of Proveblue (TM).
Most read news
Other news from the department research and development
Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.