With this approval, the MPA has confirmed that Oasmia’s manufacture of cytostatics meets the requirements of current Good Manufacturing Practice (cGMP). Oasmia now has a fully approved production facility for manufacture of cytostatics for the EU market.
”This approval is a critical step to bring our products to the market and we are very pleased that the Swedish MPA confirms Oasmia’s ability to manufacture high quality products”, said Julian Aleksov, CEO of Oasmia Pharmaceutical AB.
Notes to editors:
About cGMP
cGMP (Current Good Manufacturing Practice) is a regulatory framework with requirements as to how a medicinal product must be manufactured in order to receive a market authorization. That these requirements are met is verified by regular inspections from pharmaceutical authorities.
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ OMX Stockholm (OASM) and the Frankfurt Stock Exchange (OMAX, ISIN SE0000722365).