SFDA approves China Pharma Holdings' generic Omeprazole Sodium injection

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."


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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