Reliable Biopharmaceutical LLC Announces Submission of its Drug Master File for Edaravone to the Japanese Regulatory Agency
St. Louis, MO 7/28/2011…. Reliable Biopharmaceutical LLC (RBC) announced today that they have submitted to the Japanese Regulatory Agency its Drug Master File (DMF) for Edaravone.
Edaravone is approved for use in Japan. It eliminates harmful free radicals that have been found to increase in the area of constricted blood flow associated with Ischaemic strokes. Ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain. It accounts for 87 percent of all stroke cases.
The current market size for Edaravone is $308.5 Million growing at 8% (as reported by IMS Health)
Mr. David Feldker, President and CEO, Reliable Biopharmaceutical Corp. said, “RBC’s increased API product introduction highlights the scientific strength and value Reliable brings to the global generic market.”
About Reliable Biopharmaceutical Corporation
Founded in 1968, RBC is an integrated developer and manufacturer of active pharmaceutical ingredients ("APIs") and High Purity Ingredients ("HPIs") for pharmaceuticals and biologics. RBC has established a strong position as a leading developer and manufacturer of complex generic injectable APIs. The Company has developed 18 generic injectable APIs to date that have been approved as Type II Drug Master Files by the FDA and has 14 more in various stages of development. RBC's products are the active ingredients for leading generic injectable drugs that treat cancer, heart disease, hypertension, anxiety and other serious and life threatening illnesses. RBC also manufactures critical processing aids for the pharmaceutical industry and currently supplies these products to many of the world's leading pharmaceutical and biotechnology companies.
For more information, contact:
Reliable Biopharmaceutical LLC
James Wickenhauser, Vice President Sales and Marketing
1945 Walton Road
St. Louis, MO 63114