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Saturday, March 6, 2010

Provepharm : acceptance of Proveblue® injectable drug MAA for review under EMEA centralized procedure and validation by Novasep of API cGMP process

Pompey and Marseille, France, February 11 2010 - Novasep, a leading supplier of manufacturing solutions to the life sciences industries, and Provepharm, a start-up specialized in the development of pharmaceutical applications for Proveblue®, announce the successful validation by Novasep of a cGMP manufacturing process for the Proveblue® active pharmaceutical ingredient. This is a major step in bringing compliant methylene-blue-based drugs to market.
At the same time, Provepharm announces that the European Medicines Agency (EMEA) has accepted for evaluation the Marketing Authorisation Application (MAA) for Provepharm’s Methylthioninium chloride Proveblue® solution for injection under the Community centralized procedure.
Patented and compliant Proveblue® active pharmaceutical ingredient (API) opens the way to researching and developing methylene-blue-based drug products in a variety of applications, including urinary and ocular antiseptics as well as anti-malarial agents...

...Novasep
About Novasep
Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules. The global manufacturing solutions offered by Novasep include process development services; purification equipment and systems; contract manufacturing services; and complex active molecules. They apply to:
Synthetic molecules, combining conventional chemistry with special technologies and know-how such as hazardous chemistry, asymmetric synthesis, HPAPI handling, low temperature chemistry, biocatalysis, process chromatography, etc.
Biomolecules, with single unit operations or complete upstream and downstream processes including fermentation and cell culture, innovative batch and continuous purification technologies such as membrane processes, ion exchange, chromatography, crystallization and formulation...

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ProvepharmAbout Provepharm
Provepharm is an affiliated company of the Provence Technologies Group, devoted to developing and marketing pharmaceutical drug products from active pharmaceutical ingredients synthesized and patented by its parent company. Provepharm expertise is in experienced managers coming from the international pharmaceutical industry. As one of its strategic lines, the Group recognized the pharmaceutical industry trend to explore known compounds in new indications and its increasing need for accessing such API’s at the required level of quality...Novasep's Press Release - [PDF] Provepharm's Press Release -