China Pharma Receives SFDA Approval For Generic Bumetanide Injection
Generic Bumetanide Injection
China Pharma Holdings has received approval from Chinese SFDA for the production of generic Bumetanide injection which is used to manage hypertension and edema associated with congestive heart failure, cirrhosis, and renal disease, including the nephrotic syndrome by inducing dieresis.
Bumetanide is internationally recognized as one of the most effective diuretics and widely prescribed for cardiovascular diseases, kidney diseases, respiratory diseases, neurological diseases, and surgeries. It has replaced Furosemidum and other diuretic medications on the market because of its efficiency and safety. Bumetanide is on China's National Medical Reimbursement Insurance List thus allowing insured patients to receive reimbursement for the costs of injections. In China, medium size hospitals dispense on average 8,000 doses of Bumetanide per month.
"We are very pleased that we received approval of Bumetanide from the Chinese SFDA, a very important and positive milestone for our business which further diversifies and complements our core product portfolio," Ms. Zhilin Li, President and CEO of China Pharma Holdings, Inc., commented. "We believe this favorable decision by the SFDA is a positive sign that the SFDA new drug approval process is coming back online. For this reason, we are optimistic that the additional drugs that are currently in our development pipeline for SFDA approval will be able to move through this process toward commercialization."
"Additionally, we are well positioned to take advantage of this new growth opportunity. This approval will enable China Pharma to immediately leverage our production capacity and extensive distribution network covering 30 provinces to start production and marketing of this new drug. We expect to begin Bumetanide production and recording of revenues in March 2008. We currently maintain the capacity to produce approximately $2 million of this product annually," concluded Ms. Li.