Canadian Pharma Company Passes U.S. FDA Inspection
Uman Pharma has passed inspection by the U.S. FDA, and the company reports that its Candiac facility has been cleared to manufacture products for sale 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, in a statement issued by the company.
In addition to this U.S. 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, the company reports.
For more details, visit www.umanpharma.com.