Oasmia Announces Successful FDA Pre-Approval Inspection of Its Manufacturing Facility

UPPSALA, Sweden, December 3, 2013 /PRNewswire/ --

The Swedish pharmaceutical company Oasmia Pharmaceutical AB (publ), listed on Nasdaq OMX in Stockholm and the Frankfurt Stock Exchange, today announced that its manufacturing facility in Uppsala, Sweden, has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA).

With this inspection, the FDA has confirmed that Oasmia's manufacture meets the requirements of Current Good Manufacturing Practice (cGMP).

"This is a significant milestone in our endeavours to bring our products to the market, and we are very pleased that the FDA has confirmed Oasmia's cGMP manufacturing capability and commitment to provide products of high quality", said Julian Aleksov, CEO of Oasmia Pharmaceutical AB.    

Notes to editors:

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).

About cGMP

cGMP (Current Good Manufacturing Practice) is a regulatory framework with requirements how a medicinal product must be manufactured in order to be eligible for a marketing authorization, and that these requirements are fulfilled is controlled by i.e. authorities' inspections. For additional information see: http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm.

Information is also available at http://www.oasmia.com http://www.nasdaqomxnordic.com http://www.boerse-frankfurt.de. twitter.com/oasmia"Oasmia is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at X a.m. CET on XX."