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China Pharma Holdings, Inc. Announces SFDA Approval for Production of Omeprazole Injections

Friday, September 18, 2009 General News J E 4
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HAIKOU CITY, China, Aug. 18 China PharmaHoldings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI), which develops,manufactures, and markets specialty pharmaceutical products in China, todayannounced that it has received approval from the Chinese State Food and DrugAdministration ("SFDA) for the production of generic Omeprazole Sodiuminjections.

Omeprazole is widely utilized to treat gastroesophageal reflux disease(GERD), and is highly effective in other conditions caused by excess acidicformulations in the stomach, including gastric ulcers, recurrent duodenalulcers and Zollinger-Ellison Syndrome.

Omeprazole is a gastric proton pump inhibitor. This product is asubstituted benzimidazole derivative which acts on the final step of gastricacid production and therefore controls acid secretion in response to allvarieties of stimuli. Omeprazole was first marketed in the US by AstraZenecaunder the brand names Losec and Prilosec (it is estimated that patients havebenefited from over 900 million treatments since its launch(1)), and is nowalso available from generic manufacturers under various brand names.Omeprazole is on China's National Medical Reimbursement Insurance List,allowing insured patients to receive reimbursement for the cost of injections,and has been included in the WHO (World Health Organization) Model List ofEssential Medicines in March 2009.

China Pharma's CEO and President, Ms Zhilin Li, commented, "We are verypleased that the SFDA has approved China Pharma's production of OmeprazoleSodium injections. Omeprazole, a selective inhibitor for gastric acidsecretion, is one of the most widely prescribed drugs in the world today(2).The market of gastrointestinal (GI) disorders is one of the largest and mostprofitable therapeutic areas for the global pharmaceutical industry. With areported $49.9bn in revenue in 2007 worldwide, GI diseases consistently rankswith cardiovascular diseases and oncology in the top 3 therapeutic areas interms of market value(3). While most oral Omeprazole preparations areenteric-coated due to the rapid degradation of the drug in the acidicconditions of the stomach; our injection product is formulated in freeze-driedpowder, as a result, it enters the blood circulation faster and worksefficiently toward absorption and avoiding degradation."

Ms. Li continued, "We believe that this approval provides us with anexciting opportunity to extend our product portfolio, and we expect it tocreate value for our patients and shareholders over time."

About China Pharma Holdings, Inc.

China Pharma Holdings, Inc. is a specialty pharmaceutical company withrapidly growing profit that develops, manufactures, and markets treatments fora wide range of high incidence and high mortality conditions in China,including cardiovascular, CNS, infectious, and digestive diseases. TheCompany's cost-effective, high margin business model is driven by marketdemand and supported by eight scalable GMP-certified product lines coveringthe major dosage forms. In addition, the Company has a broad and expandingdistribution network across 30 provinces, municipalities and autonomousregions. The Company is registered in Delaware, USA. Hainan Helpson Medical &Biotechnology Co., Ltd. (Helpson), located in Haikou City, Hainan Province,China, is a wholly owned subsidiary of China Pharma Holdings, Inc. For moreinformation about China Pharma Holdings, Inc., please visithttp://www.chinapharmaholdings.com .

Safe Harbor Statement

Certain statements in this press release and oral statements made by ChinaPharma on its conference call in relation to this release, constitute forward-looking statements for purposes of the safe harbor provisions under ThePrivate Securities Litigation Reform Act of 1995. Any statements set forthabove that are not historical facts are forward-looking statements thatinvolve risks and uncertainties that could cause actual results to differmaterially from those in the forward-looking statements, which may include,but are not limited to, such factors as unanticipated changes in productdemand, increased competition, failure to obtain or maintain intellectualproperty protection, downturns in the Chinese economy, uncompetitive levels ofresearch and development, failure to obtain regulatory approvals, and otherinformation detailed from time to time in the Company's filings and futurefilings with the United States Securities and Exchange Commission. Theforward-looking statements made herein speak only as of the date of this pressrelease and the Company undertakes no duty to update any forward-lookingstatement to conform the statement to actual results or changes in thecompany's expectations.(1) Source: Astrazeneca Annual Report And Form 20-F Information 2008 (2) Source: Analytica Chimica Acta 2009 Vol.633(no.2) Maria Rambla- AlegreJosep Esteve-RomeroSamuel Carda-Broch "Analysis of omeprazole and its main metabolites by liquid chromatography using hybrid micellar mobile phases" (3) Source: World Gastrointestinal Disorders Market 2008-2023 For more information, please contact: China Pharma Holdings, Inc. Tel: +86-898-6681-1730 Email: hps@chinapharmaholdings.com ICR, Inc. Christine Duan Tel: +1-203-682-8200

SOURCE China Pharma Holdings, Inc.
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