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SFDA approves China Pharma Holdings' generic Omeprazole Sodium injection

Published on August 19, 2009 at 4:21 AM · No Comments

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.

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