CANDIAC, QC, June 4, 2013 /CNW Telbec/ - Uman Pharma is pleased to announce that it has successfully passed its inspection by the United States Food and Drug Administration (FDA). The agency has thus communicated to Uman Pharma that the positive results of its establishment inspection of the facility clears the way for sale of products manufactured at the Canadian facility in the United States.
"The FDA is arguably one of the most stringent regulatory agencies. This positive news will allow Uman to operate in some of the most restrictive regulatory environments. It will provide Uman Pharma with an important commercial opportunity and a strategic positioning since it is one of the few cytotoxic facilities in North America that can manufacture products for the Canadian, American and European markets." said Sylvain Duvernay, Uman Pharma's President and CEO.
Uman Pharma is physically located in a hub of the pharmaceutical industry and now has strategic access to the largest regulated markets. In addition to this US approval, Canada benefits from a mutual recognition accord with the European Medicines Agency (EMA) where Uman Pharma has launched its Methotrexate pre-filled syringes in Germany and other countries.
CFR Pharmaceuticals, Uman Pharma's majority shareholder, and an important player in the rapidly growing South American markets, is pleased of the outcome of this inspection, the result of a continuous effort carried by Uman and CFR since the year 2012.
About Uman Pharma
Uman Pharma is a global pharmaceutical company based in Candiac, on the South Shore of Montreal, Canada. Its strengths lie in the development and manufacturing of cytotoxic and high potent sterile injectables for the oncology market. Uman's portfolio of products includes complex and generic formulations, backed by an experienced and professional team and GMP manufacturing facilities (11,700m2).
Please visit www.umanpharma.com for more information.
About CFR Pharmaceuticals
CFR Pharmaceuticals S.A. is a leading Latin American pharmaceutical company with operations in 15 countries in Latin America (mainly Chile, Peru, Argentina and Colombia), and other emerging markets. Its business model is focused on the development, manufacture and commercialization of off-patent and locally unpatented branded specialty pharmaceutical products. The company manages its operations along several business segments.
Please visit www.cfr-corp.com for more information.
SOURCE: UMAN PHARMA INC.
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