Suzhou Erye Pharma gets Chinese approval to manufacture generic cloxacillin
NeoStem, Inc, an international biopharmaceutical company with operations in the US and China, announced that its Suzhou Erye Pharmaceutical subsidiary (Erye) recently 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. 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.
NeoStem's chairman and CEO, Robin Smith, commented, "Cloxacillin sodium is the second of seven drugs in Erye's pipeline to be approved since the acquisition of our 51 per cent 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."
"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," said Madam Jian Zhang, Erye's general manager. "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."
NeoStem acquired its 51 per cent interest in Erye through its acquisition of China Biopharmaceutical Holdings, Inc. in October 2009.
NeoStem is engaged in the development of stem cell-based therapies and building of a network of adult stem cell collection centres in the US and China that are focused on enabling people to donate and store their own (autologous) stem cells for their personal use in times of future medical need.