-- The Approval Creates New Growth Opportunities for the Company
-- Potentially Denotes a Positive Sign Related to the SFDA Drug Approval Process
NEW YORK and HAIKOU, China, Jan. 29 /Xinhua-PRNewswire-FirstCall/ -- China Pharma Holdings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI) which develops, manufactures, and markets generic and brand bio-pharmaceutical products in China, announced today that it has received approval from the Chinese State Food and Drug Administration (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.
About China Pharma Holdings, Inc.
China Pharma Holdings, Inc. develops, manufactures, and markets generic and brand bio-pharmaceutical products in China that treat a wide range of conditions, including infections, hepatitis, cardiovascular and CNS diseases, and other prevailing diseases. Helpson Bio-pharmaceutical Co., Ltd (Helpson), a specialty pharmaceutical company headquartered in Haikou City, Hainan province in China, is a wholly owned subsidiary of China Pharma Holdings. For more information about China Pharma Holdings, Inc., please visit http://www.chinapharmaholdings.com .
Safe Harbor Statement:
Certain statements in this press release and oral statements made by China Pharma on its conference call in relation to this release, constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, which may include, but are not limited to, such factors as unanticipated changes in product demand, increased competition, failure to obtain or maintain intellectual property protection, downturns in the Chinese economy, uncompetitive levels of research and development, failure to obtain regulatory approvals, and other information detailed from time to time in the Company's filings and future filings with the United States Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this press release and the Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the company's expectations.
For more information, please contact:
Sophia Yu
China Pharma Holdings, Inc.
Tel: +86-898-6681-1730
Email: hps@chinapharmaholdings.com
Alan Sheinwald
HC International, Inc.
Tel: +1-914-669-0222
Email: Alan.sheinwald@hcinternational.net
