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China Pharma wins approval for Tiopronin enteric-coated capsules

China Pharma Holdings, a developer, manufacturer and marketer of specialty pharmaceuticals, has received approval from China's State Food and Drug Administration for the production of Tiopronin enteric-coated capsules. Tiopronin is listed in the National Medical Insurance Program, thus allowing patients to obtain reimbursement.

Tiopronin tablets are prescribed in several countries for the treatment of acute and chronic hepatitis B, and for the relief of drug-induced liver injury. However, this drug can cause stomach irritation; therefore, its use and patient compliance may be limited by the side effects.

To address this, China Pharma said that it has developed Tiopronin capsules with an enteric coating to decrease the stomach mucosal irritation associated with Tiopronin. As a result, China Pharma’s Tiopronin enteric-coated format improves liver function while protecting the stomach, the company added.

Zhilin Li, China Pharma’s president and CEO, said: “The competitive advantage of our enteric coating, coupled with the reimbursement available, make Tiopronin enteric-coated capsules a superior treatment option for liver disease. The increased intestinal absorption of our product, Tiopronin enteric-coated capsules, is consistent with reduced gastric irritation, and higher bioavailability.

“All these advantages of the enteric-coated format which is the fruit of our product differentiation strategy, will create a stronger market position for China Pharma and bring positive influence on our 2009 operating targets.”