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news.NeoStem, an international biopharmaceutical company, has reported that its Suzhou Erye Pharmaceutical subsidiary (Erye), has received approval from the State Food and Drug Administration (SFDA) in China to manufacture the sterile active pharmaceutical ingredient (API) of the anti-infective cloxacillin sodium.
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Cloxacillin sodium, a generic form Cloxapen, in finished dosage form is listed in China’s National Medical Reimbursement Insurance List and thus is eligible for reimbursement by the government’s healthcare programs.
Robin Smith, chairman and CEO at NeoStem, said: “Cloxacillin sodium is the second of seven drugs in Erye’s pipeline to be approved since the acquisition of our 51% interest in Erye and is an important addition to the company’s product offerings. As a result of China’s healthcare reform, there will be an increase in access to healthcare professionals and medical products for the 1.3 billion people in China with a planned 30,000 new clinics and hospitals.
“This unprecedented government effort to provide universal healthcare coverage should undoubtedly increase demand for prescription antibiotics, many of which are covered as ‘essential medicines’ under the new healthcare insurance system.”
Madam Jian Zhang, general manager at Erye, said: “While there are many other manufactures in China approved to manufacture generic antibiotics, China’s large market is more than sufficient to provide a significant opportunity for Erye. It is an important part of our strategy to expand our offerings of generic drugs and we hope to commercially launch the drug in the summer, along with generic omeprazole that was approved in November 2009.”