Sinobiopharma’s production facility for solid dosage Perindopril has passed Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.
The company received SFDA approval for its formulation of Perindopril in April 2009. SFDA regulations require that drug makers conduct large-scale production of at least three batches of a newly approved drug in a GMP certified production facility. SFDA officials inspect the production process, the application of GMP standards, and conduct a full test of randomly picked samples of the drug.
Perindopril is part of a class of medications known as angiotensin-converting enzyme (ACE) inhibitors that are used alone or in combination with other medications to treat high blood pressure. The drug will be marketed under the trade name YiTai in China.
"We believe that YiTai is a first-to-market drug in China and therefore enjoys the benefit of having a government sanctioned price premium as well as certain exclusive marketing rights to hospitals," said Dr. Lequn Lee Huang, chief executive officer of Sinobiopharma. "The market for anti-hypertensives in China is huge, but highly fragmented. Sinobiopharma's YiTai is well positioned to capture substantial market share quickly."