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China Pharma Holdings, Inc. Announces SFDA Approval for Prod

编辑:918 日期:2019-01-08

Broadens Product Offerings for MulAAAle Therapeutic Markets

HAIKOU CITY, China, Aug. 18 /PRNewswire-Asia-FirstCall/ -- China Pharma Holdings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that it has received approval from the Chinese State Food and Drug Administration ("SFDA) for the production of generic Omeprazole Sodium injections.

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

Omeprazole is a gastric proton pump inhibitor. This product is a substituted benzimidazole derivative which acts on the final step of gastric acid production and therefore controls acid secretion in response to all varieties of stimuli. Omeprazole was first marketed in the US by AstraZeneca under the brand names Losec and Prilosec (it is estimated that patients have benefited from over 900 million treatments since its launch(1)), and is now also 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 of Essential Medicines in March 2009.

China Pharma’s CEO and President, Ms Zhilin Li, commented, "We are very pleased that the SFDA has approved China Pharma’s production of Omeprazole Sodium injections. Omeprazole, a selective inhibitor for gastric acid secretion, 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 most profitable therapeutic areas for the global pharmaceutical industry. With a reported $49.9bn in revenue in 2007 worldwide, GI diseases consistently ranks with cardiovascular diseases and oncology in the top 3 therapeutic areas in terms of market value(3). While most oral Omeprazole preparations are enteric-coated due to the rapid degradation of the drug in the acidic conditions of the stomach; our injection product is formulated in freeze-dried powder, as a result, it enters the blood circulation faster and works efficiently toward absorption and avoiding degradation."

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

About China Pharma Holdings, Inc.

China Pharma Holdings, Inc. is a specialty pharmaceutical company with rapidly growing profit that develops, manufactures, and markets treatments for a wide range of high incidence and high mortality conditions in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company’s cost-effective, high margin business model is driven by market demand and supported by eight scalable GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding distribution network across 30 provinces, municipalities and autonomous regions. 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 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’AAAApectations.

(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 hybriAAAAAAAA> 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

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