Sinobiopharma Gets SFDA Approval For Producing Solid Dosage Perindopril

Sinobiopharma received SFDA approval for its formulation of Perindopril, the first version of the drug to be developed in China, 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 Good Manufacturing Practice (GMP) certified production facility.

The company said that SFDA officials inspect the production process, the application of GMP standards, and conducted a full test of randomly picked samples of the drug. Sinobiopharma successfully met all the requirements and now has received approval to distribute the drug throughout China.

The company believes its formulation of Perindopril is the latest generation of the product, which is part of a class of medications known as angiotensin-converting enzyme (ACE) inhibitors. These medications are used alone or in combination with other medications to treat high blood pressure.

Perindopril allows blood to flow more smoothly by preventing the production of certain natural chemicals that constrict blood vessels. Sinibiopharma’s Perindopril will be marketed under the trade name, YiTai, in China.

Lequn Lee Huang, CEO of Sinobiopharma, said: “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. The market for anti-hypertensives in China is huge, but highly fragmented. Sinobiopharma’s YiTai is well positioned to capture substantial market share quickly.”