The completion of the Health Canada inspection and the issuance of a compliant rating are major milestones for Therapure Biopharma
Toronto, ON (PRWEB) July 1, 2009
Thomas Wellner, President and CEO of Therapure Biopharma Inc. today announced that the Company has received a compliant rating from the Health Products and Food Branch Inspectorate of Health Canada.
The rating results from a Good Manufacturing Practices (GMP) inspection conducted at the Company's Meadowpine facility between May 19 and June 12, 2009. The compliant rating means that the Company has demonstrated that the aseptic fill/finish activities conducted in the facility and the associated support services are in compliance with the Canadian Food and Drugs Act and its associated regulations. Based on the results of the inspection, Therapure Biopharma expects to be issued an Establishment License for the Meadowpine facility.
In addition to being recognized in Canada, under the terms of the Mutual Recognition Agreements between Canada and the European Community and Australia, this Establishment License will be recognized by the European Medicines Agency (the EMEA) and the Australian Therapeutic Goods Administration.
"The completion of the Health Canada inspection and the issuance of a compliant rating are major milestones for Therapure Biopharma," said Thomas Wellner. "We have been focused on achieving GMP standards in our facility since acquiring these assets in 2007. Therapure Biopharma staff have devoted their energies to achieving the highest standards of quality, and it has paid off."
GMP standards are the benchmark that must be applied by all manufacturers of approved biopharmaceuticals. As a result of achieving the compliant rating, Therapure Biopharma will be licensed to provide formulation, filling, packaging, and testing services for approved biotherapeutic, Schedule F prescription pharmaceutical, and plasma-derived biological products.
About Therapure Biopharma:
Therapure Biopharma Inc. is an integrated biopharmaceutical company that develops, manufactures, purifies, and packages therapeutic proteins. Therapure Biopharma is also a specialist in the development of therapeutics derived from a wide range of biological sources, including hemoglobin, a blood protein. As a contract development and manufacturing organization (CDMO), Therapure Biopharma applies scientific, manufacturing, and downstream purification expertise with an intimate understanding of advanced biology, complex proteins, and regulatory processes to develop effective and innovative solutions to advance products from discovery to market.
For more information, please visit: http://www.therapurebio.com